Efficacy of recombinant human deoxyribonuclease I in the hospital management of respiratory syncytial virus bronchiolitis.

OBJECTIVE: To evaluate the effect of recombinant human deoxyribonuclease I (rhDNase) in shortening the length of the hospitalization and improving the chest radiographs (CXRs) in hospitalized infants with respiratory syncytial virus (RSV) infection as a result of its mucolytic properties. METHODS: Randomized, double-blind, placebo-controlled investigation of 75 patients with RSV bronchiolitis. The study was conducted at the University of Michigan Medical Center and St. Joseph Mercy Hospital, both in Ann Arbor, MI. RESULTS: The respiratory rate, wheezing, and retraction difference scores, obtained by subtracting the hospital discharge score from the corresponding hospital admission score, show no difference between the two groups, but the CXR difference scores show that the rhDNase group improved by 0.46 while the placebo group worsened by 0.60 (p < 0.001). Analysis of covariance for the hospital discharge CXR score after adjusting for the hospital admission score for both groups was done. There was a difference in scores between the two groups, with adjusted mean for the study group of 2.03, and 2.76 for the placebo group (p < 0.001). Paired t test statistics in each of the two groups were computed. For the placebo group, the mean increase of 0.60 was significant (p = 0.02), and the mean decrease of 0.46 for the rhDNase group was also significant (p = 0.02). A one-way analysis of covariance with the hospital discharge CXR scores as the dependent variable and the hospital admission score as the covariate showed that there was a significant difference between the groups (p = 0.01). CONCLUSION: In patients with RSV bronchiolitis, there was significant improvement in the CXRs with the use of rhDNase compared to significant worsening in the placebo group. To our knowledge, this is the first report of the use of rhDNase to treat RSV bronchiolitis.

Venovenous versus venoarterial extracorporeal life support for pediatric respiratory failure: are there differences in survival and acute complications?

OBJECTIVES: To examine the Extracorporeal Life Support Organization (ELSO) registry database of infants and children with acute respiratory failure to compare outcome and complications of venovenous (VV) vs. venoarterial (VA) Extracorporeal Life Support (ECLS). DESIGN: Retrospective cohort study. SETTING: ELSO registry for pediatric pulmonary support. PATIENTS: All nonneonatal pediatric pulmonary support ECLS cases treated at U.S. centers and reported to the ELSO registry as of July 1997. Patients were excluded if they had one or more of the following diagnoses: hematologic-oncologic, cardiac, abdominal surgical, burn, metabolic, airway, or immunodeficiency disorder. INTERVENTIONS: Venoarterial or venovenous extracorporeal life support for severe pulmonary failure. MEASUREMENTS AND MAIN RESULTS: From 1986 to June of 1997, 763 pediatric patients met the inclusion criteria. Overall, 595 were initially managed with VA bypass, and 168 with VV bypass. The VA group was younger (mean +/- SD, 26.1+/-42.2 months for VA vs. 63.5+/-68.7 months for VV) and smaller (11.8+/-15.1 kg vs. 22.9+/-23.8 kg) (p<.001). There were no differences between groups in number of days on mechanical ventilation before ECLS, number of hours on ECLS, or number of hours on mechanical ventilation post-ECLS in survivors. Mean pH and Paco2 values, positive end-expiratory pressure, and mean airway pressure just before placing the patient on ECLS were also similar. VA-treated patients had higher Fio2 requirements (p = .034), lower Pao2 (p = .047), and lower Pao2/Fio2 ratio (p = .014) just before cannulation. There was a trend of higher peak inspiratory pressure in VA-treated patients (p = .053). Overall, survival rate was not different for the two groups (55.8% for VA vs. 60.1% for VV; p = .33). Central nervous system complications were not different between the two groups. Examination of the same variables was then conducted after dividing the patients into four subgroups. There were no significant differences in survival or complications during bypass between VV and VA modes of ECLS in any subgroup. Stepwise logistic regression modeling was performed to control for variables associated with the outcome survival for VV and VA-treated groups, and variables measured before bypass were identified as being associated with improved survival. There was a trend of improved survival in the VV-treated patients (p = .12). CONCLUSIONS: Overall survival of pediatric patients with acute respiratory failure supported by VA or VV ECLS was comparable. A randomized clinical trial may be useful in clarifying these observations.

Severity of illness models for respiratory syncytial virus-associated hospitalization.

The objective of this investigation was to examine the feasibility of multivariate severity of illness models for pediatric patients hospitalized with respiratory syncytial virus (RSV) infection. From a preexisting retrospective cohort study database, all infants and children 2 yr of age or younger with community-acquired RSV infection admitted to the University of Michigan's C. S. Mott Children's Hospital during nine epidemics were examined. The study group consisted of 802 hospitalized patients younger than 2 yr of age with community-acquired RSV infection; 182 (23%) patients had prolonged hospital length of stay defined as 7 d or greater. Multivariate logistic regression modeling of nine variables measurable during the first hospital day was strongly associated with prolonged hospitalization (p < 0.0001). Receiver operator characteristic curve analysis resulted in an area under the curve of 0.894, indicating excellent model discrimination. Goodness-of-fit testing indicated excellent model calibration for observed versus predicted outcomes (p = 0.216). We conclude that severity of illness models for RSV-associated hospitalization with excellent predictive properties in terms of classification, discrimination, and calibration are possible. Further study is required to determine if such models are generalizable across multiple centers and epidemics.

Outcome-associated factors in pediatric patients treated with extracorporeal membrane oxygenator after cardiac surgery.

BACKGROUND: The use of the extracorporeal membrane oxygenator (ECMO) for postoperative cardiac patients has not resulted in the same high success rate as when ECMO is used for neonates with pulmonary hypertension or pulmonary failure. The reason for this is poorly understood. METHODS AND RESULTS: We analyzed retrospectively all pediatric patients placed on ECMO after surgery for a congenital heart lesion between 1981 and 1995 (n = 64). Patients had a two-ventricular repair (A) or pulmonary blood flow supplied by an aortopulmonary shunt (B) or by a cavopulmonary connection (C). Indication for ECMO was unsatisfactory hemodynamics due to (1) ventricular dysfunction, (2) pulmonary failure, (3) pulmonary hypertension, or (4) a combination or (5) for unclear reasons. Hospital survival was related to these and other factors. Overall hospital survival was 33%; 42% of group A patients survived to discharge, whereas only 25% and 17% survived in groups B and C, respectively. Survival was unrelated to the indication for ECMO but appeared to be lower when ECMO was initiated in the operating room or > 50 hours after surgery. Except for one patient with pneumonia, no patient survived who was on ECMO for > 208 hours. ECMO discontinuation in nonsurvivors was due to neurological (30%) or multiple complications (39%), the lack of return of cardiac function (12%), or other reasons (15%). CONCLUSIONS: This review suggests that the diagnosis of single ventricle, initiation of ECMO in the operating room or > 50 hours after surgery, and ECMO for > 208 hours are associated with patient nonsurvival. Noncardiac complications more frequently led to discontinuation of ECMO than did failure of the return of cardiac function.

Ribavirin utilization and clinical effectiveness in children hospitalized with respiratory syncytial virus infection.

Ribavirin was approved in early 1986 for treatment of illness associated with respiratory syncytial virus (RSV) infection in hospitalized children; however, the value of its use remains controversial. This investigation was undertaken to describe ribavirin utilization and to evaluate the effectiveness of ribavirin in reducing the period of hospitalization. All children with laboratory-confirmed RSV infection, hospitalized over seven epidemic periods at a single institution, were identified. Characteristics from the medical records of the 768 children and their course of hospitalization were evaluated as determinants of treatment with ribavirin. Very young age as well as diagnoses of congenital heart disease, certain pulmonary conditions, and failure to thrive were all significantly related to increased likelihood of treatment. Children requiring intensive care were likely to be treated; however, the most critically ill children, those who required mechanical ventilation, were not treated. Although these results were in keeping with treatment guidelines for the use of ribavirin, actual utilization declined significantly over the course of the evaluation. The effect of ribavirin treatment on the duration of hospitalization among children with community-acquired infection was evaluated in a multivariate model, which controlled for the effects of underlying conditions, measures of illness severity, and epidemic year. This analysis failed to demonstrate a benefit for ribavirin in reducing length of stay; in fact, ribavirin treatment was significantly associated with prolonged hospitalization. It was not likely that the explanation for ribavirin's association with prolonged hospitalization was that the most seriously ill children were treated; however, it was not possible to determine whether this association was due to an adverse effect of treatment or resulted from a perceived need to complete the course of therapy.

Mechanical ventilation and arterial blood gas measurements 24 hours postextracorporeal life support for survivors of pediatric respiratory failure.

OBJECTIVE: To summarize our institutional experience concerning mechanical ventilation support and blood gas measurements in the 24-hr period following extracorporeal life support (ECLS) for pediatric acute respiratory failure. DESIGN: Descriptive study. SETTING: A tertiary pediatric referral center. PATIENTS: Children aged 1 month to 18 yrs treated with ECLS for acute respiratory failure at University of Michigan Hospitals from November 1982 to June 1993. All patients aged 1 month to 18 yrs who received ECLS for acute respiratory failure were included. Patients who received ECLS primarily for cardiac support or who had a diagnosis of congenital gastrointestinal malformation (i.e. congenital diaphragmatic hernia) were excluded. INTERVENTIONS: ECLS for severe pediatric respiratory failure. MEASUREMENTS AND MAIN RESULTS: Forty-nine children were treated at our center with ECLS for acute respiratory failure 36 (73%) survived. Ventilator settings immediately after decannulation from ECLS for survivors were as follows: FIO2 0.53 +/- 0.18 (SD); intermittent mandatory ventilation (IMV) 29.6 +/- 1.18 breaths/min, positive end-expiratory pressure 5.3 +/- 1.6 cm H2O, mean airway pressure 12.6 +/- 2.9 cm H2O, and peak inspiratory pressure 31.7 +/- 5.5 cm H2O. Arterial blood gas measurements at decannulation were PaO2 89.4 +/- 30.9 torr (11.9 +/- 4.1 kPa), PaCO2 43.7 +/- 9.7 torr (5.8 +/- 1.3 kPa), and pH 7.39 +/- 0.07. Twenty-four hours after decannulation, ventilator settings and arterial blood gas measurements were as follows: FIO2 0.42 +/- 0.14, IMV 27.4 +/- 13.5 breaths/min, positive end-expiratory pressure 5.2 +/- 1.6 cm H2O, mean airway pressure 12.0 +/- 3.4 cm H2O, peak inspiratory pressure 31.1 +/- 6.5 cm H2O, PaO2 77.0 +/- 16.9 torr (10.3 +/- 2.3 kPa), PaCO2 44.9 +/- 8.4 torr (6.0 +/- 1.1 kPa), and pH 7.40 +/- 0.07. Variables associated with oxygenation status (P[A-a]O2) and mean airway pressure (oxygenation index) improved during the immediate 24-hr period postbypass (p < .05). CONCLUSIONS: Successful decannulation from ECLS for > 24 hrs resulted in long-term survival in 97% (36/37) of children. Ventilator parameters and arterial blood gas measurements during the 24-hr period following bypass have been described for this population. Such conventional support may indicate safe levels of oxygen and mechanical ventilation pressures for the postbypass recovering lung.

Effectiveness of ribavirin in otherwise well infants with respiratory syncytial virus-associated respiratory failure. Pediatric Critical Study Group.

OBJECTIVE: To examine ribavirin's effectiveness in otherwise well infants with respiratory syncytial virus (RSV)-associated respiratory failure. DESIGN: Prospective multicenter cohort study. SETTING: Pediatric critical care units affiliated with the Pediatric Critical Care Study Group; 38 centers from the United States and Canada participated. PATIENTS: Infants with RSV-associated respiratory failure undergoing mechanical ventilation. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: Data collected included demographic information; dates of hospitalization, intensive care, and mechanical ventilation; all patient diagnoses; reason for tracheal intubation; dates of ribavirin use before and during mechanical ventilation; time in hours after intubation until ribavirin administration; Pediatric Risk of Mortality (PRISM) score; and outcome. A total of 439 patients received mechanical ventilation for RSV-associated respiratory failure; 223 were classified as previously well and met entry criteria. Ninety-one infants (41%) received ribavirin during mechanical ventilation. The PRISM scores during the initial 24 hours of intensive care and blood gas measurements before intubation were similar for patients who received ribavirin versus those who did not. Use of ribavirin during mechanical ventilation was associated with prolonged duration of mechanical ventilation (p < 0.01) in a multivariate model that controlled for patient age, gender, prematurity status, and use of ribavirin before intubation. Subgroup analysis of mechanical ventilation days for previously well patients was 5.0 +/- 4.2 in the no-ribavirin group versus 6.4 +/- 5.0 in the ribavirin group (p < 0.05) and for well premature infants was 6.3 +/- 4.9 in the no-ribavirin group versus 9.0 +/- 6.3 in the ribavirin group (p < 0.01). The mortality rates for the term and the premature groups were similar for treated and untreated patients. CONCLUSIONS: Ribavirin administration during mechanical ventilation to previously well infants with RSV infection was not associated with reductions in either mortality rates or duration of mechanical ventilation. Additional clinical effectiveness studies are required to define specific groups in which the use of aerosolized ribavirin is indicated.

The impact of extracorporeal membrane oxygenation on survival in pediatric patients with acute respiratory failure. Pediatric Critical Care Study Group.

OBJECTIVE: Extracorporeal membrane oxygenation (ECMO) has been used with increasing frequency in the treatment of acute respiratory failure in pediatric patients. Our objective in this study was to test the hypothesis that ECMO improves outcome in pediatric patients with acute respiratory failure. DESIGN: Multicenter, retrospective cohort analysis. SETTING: Forty one pediatric intensive care units participated in the study under the auspices of the Pediatric Critical Care Study Group. PATIENTS: All pediatric patients admitted to the participating institutions with acute respiratory failure during 1991 were included. Patients with congenital heart disease, contraindications to ECMO, or incomplete data were excluded, yielding a data set of 331 patients from 32 hospitals. INTERVENTIONS: Conventional mechanical ventilation, high-frequency ventilation, and extracorporeal membrane oxygenation. MEASUREMENTS AND MAIN RESULTS: Multivariate logistic regression analysis was used to identify factors associated with survival. In a second analysis, pairs of ECMO and non-ECMO patients, matched by severity of disease and respiratory diagnosis, were compared. The use of ECMO (p = .0082), but not the use of high-frequency ventilation, was associated with a reduction in mortality. Other factors independently associated with mortality included oxygenation index (p < .0001), Pediatric Risk of Mortality score (PRISM) (p < .0001) and the Paco2 (p = .045). In 53 diagnosis- and risk-matched pairs, there was a significantly lower mortality rate (26.4% vs. 47.2%; p < .01) in the ECMO-treated patients. When all patients were stratified into mortality risk quartiles on the basis of oxygenation index and PRISM score, the proportion of deaths among ECMO-treated patients in the 50% to 75% mortality risk quartile was less than half the proportion in the non-ECMO treated patients (28.6% vs. 71.4% p < .05)> No effect was seen in the other quartiles. CONCLUSIONS: The use of ECMO was associated with an improved survival in pediatric patients with respiratory failure. The lack of association of outcome with treatment in the ECMO-capable hospital or with another tertiary technology (i.e. high-frequency ventilation) suggests that ECMO itself was responsible for the improved outcome. Further studies of this procedure are warranted but require broad-based multi-institutional participation to provide sufficient statistical power and sensitivity to demonstrate efficacy.

Initial experience with partial liquid ventilation in pediatric patients with the acute respiratory distress syndrome.

OBJECTIVE: Liquid ventilation with perfluorocarbon previously has not been reported in pediatric patients with respiratory failure beyond the neonatal period. We evaluated the technique of partial liquid ventilation in six pediatric patients with the acute respiratory distress syndrome of sufficient severity to require extracorporeal life support (ECLS). DESIGN: This study was a noncontrolled, phase I/II experimental study with a single group pretest/posttest design. SETTING: All studies were performed at a tertiary, pediatric referral hospital at the University of Michigan Medical School. PATIENTS: Six pediatric patients, from 8 wks to 5 1/2 yrs of age, with severe respiratory failure requiring ECLS to support gas exchange. INTERVENTIONS: After 2 to 9 days on ECLS, perfluorocarbon was administered into the trachea until the dependent zone of each lung was filled. The initial administered was 12.9 +/- 2.3 mL/kg (range 5 to 20). Gas ventilation of the perfluorocarbon-filled lungs (partial liquid ventilation) was then performed. The perfluorocarbon dose was repeated daily for a total of 3 to 7 days, with a cumulative dose of 45.2 +/- 6.1 mL/kg (range 30 to 72.5). MEASUREMENTS AND MAIN RESULTS: All measurements of native gas exchange were made during brief periods of discontinuation of ECLS and include PaO2 and the alveolar-arterial oxygen gradient, P(A-a)O2. Static pulmonary compliance, corrected for weight, was also measured directly. The mean PaO2 increased from 39 +/- 6 to 92 +/- 29 torr (5.2 +/- 0.8 to 12.2 +/- 3.9 kPa) over the 96 hrs after the initial dose (p = .021 by repeated-measures analysis of variance). The average P(A-a)O2 decreased from 635 +/- 10 to 499 +/- 77 torr (84.7 +/- 1.3 to 66.5 +/- 10.3 kPa) over the same time period (p = .059), while the mean static pulmonary compliance (normalized for patient weight) increased from 0.12 +/- 0.02 to 0.28 +/- 0.08 mL/cm H2O/kg (p = .01). All six patients survived. Complications potentially associated with partial liquid ventilation were limited to pneumothoraces in two of six patients. CONCLUSIONS: Perfluorocarbon may be safely administered into the lungs of pediatric patients with severe respiratory failure on ECLS and may be associated with improvement in gas exchange and pulmonary compliance.

Normalization of priming solution ionized calcium concentration improves hemodynamic stability of neonates receiving venovenous ECMO.

The authors' objectives in this investigation were: 1) to prospectively determine whether a normocalcemic priming solution would result in elimination of hypocalcemia after the initiation of extracorporeal membrane oxygenation (ECMO); 2) to investigate whether normocalcemia would result in improvements in the patient's hemodynamics during the initiation of ECMO; and 3) to further define the relationship between ionized calcium measurements and total calcium, serum total protein, serum albumin, and total magnesium. This was a prospective study done in our neonatal intensive care unit, and included nine neonatal patients placed on ECMO for cardiopulmonary support. The bypass circuit was primed in the standardized manner with 100 mg calcium chloride. Circuit ionized calcium measurements were performed, and additional calcium chloride was added to normalize the ionized calcium in the priming solution. Ionized calcium was measured from the circuit and the patient before the initiation of ECMO, and then again from the patient 5, 10, 15, 30, 60, 120, and 240 minutes after the initiation of ECMO. The patients' mean arterial pressure was measured simultaneously with each ionized calcium measurement. Ionized calcium, serum total calcium, total protein, serum albumin, and total magnesium were measured from blood samples simultaneously collected four times daily. There was no significant change in the ionized calcium measured in the patients after the initiation of ECMO. There was, however, a significant increase in blood pressure 5 min after the initiation of ECMO (62 +/- 7 mmHg vs 53 +/- 6 mmHg, p = 0.01). Thereafter, there was no difference in blood pressure measured when compared with pre ECMO values. A poor correlation was demonstrated between ionized calcium and total calcium (r2 = 0.35), serum total protein (r2 = 0.26), serum albumin (r2 = 0.27), and total magnesium (r2 = 0.05). On the basis of the authors' data, the initiation of ECMO with a normocalcemic prime results in a minimal change in patient ionized calcium and resolution of the hypotension previously observed. In addition, there was poor correction between ionized calcium, total calcium, and other indirect measures of ionized calcium. Ionized calcium measurements are critical for patient hemodynamic stability before bypass and should be normalized in both the patient and priming solution before the initiation of bypass.

Probability of survival after prolonged extracorporeal membrane oxygenation in pediatric patients with acute respiratory failure. Extracorporeal Life Support Organization.

OBJECTIVE: Extracorporeal membrane oxygenation (ECMO) has been used with increasing frequency for respiratory failure that is unresponsive to conventional therapy. We examined the relationship between duration of ECMO and outcome to understand whether prolonged ECMO (duration of the procedure for > 14 days) was more commonly associated with futile therapy or eventual recovery. DESIGN: A cohort study of all patients reported to the Pediatric ECMO Registry for Acute Respiratory Failure of the Extracorporeal Life Support Organization. SETTING: Tertiary hospitals (n = 83) capable of providing extracorporeal support for pediatric patients. PATIENTS: Children (n = 382) between the ages of 1 wk and 18 yrs of age with severe respiratory failure. INTERVENTIONS: Extracorporeal membrane oxygenation. MEASUREMENTS AND MAIN RESULTS: The death or live hospital discharge of ECMO-treated patients, together with the post-ECMO mechanical ventilation course, were examined as a function of duration of ECMO and of pre-ECMO respiratory status. The occurrence of complications and the causes of death were also noted. The criteria used to initiate ECMO, as well as the determination of the futility of further ECMO, were determined by local practice at individual centers. There were 382 patients treated with ECMO, of whom 184 (48%) survived. The proportional survival in the patients treated for the longest duration was similar to the overall group. The cause of death was given for 168 patients: 32 neurologic deaths; nine deaths due to ECMO complications; and 30 deaths due to nonpulmonary organ failure. There were 97 deaths due to elective ECMO termination; 80 of these deaths occurred after the determination of the futility of anticipating pulmonary recovery. The latter deaths occurred at widely varying durations of ECMO, with a median of 282 hrs. However, at that same duration, 47 eventual survivors (26% of all survivors) continued to receive ECMO. By discriminant analysis, the survival rate was independently related (r2 = .18; p < .0001) to peak ventilator inspiratory pressure before ECMO and duration of intubation before ECMO, patient age, and the occurrence of several complications. CONCLUSIONS: While the survival rate in pediatric patients receiving ECMO appears related to the severity of lung disease and to the occurrence of ECMO complications, the survival rate in patients treated with ECMO courses of > 2 wks was similar to the survival rate of patients treated for shorter periods of time. ECMO was terminated in some patients for pulmonary futility at durations of ECMO associated with survival in substantial numbers of patients in whom ECMO was continued.

Continuous versus intermittent nebulized terbutaline: plasma levels and effects.

The purpose of this investigation was to compare continuous versus intermittent nebulization of a beta 2-agonist, terbutaline, to determine whether differences exist in plasma concentrations or adverse cardiovascular effects of the drug with these two techniques for its administration. Sixteen children 6 to 16 yr of age, admitted for acute asthma, were enrolled in this randomized double-blind clinical trial. Nebulization of 16 mg of terbutaline over an 8-h period was performed either continuously or intermittently, with a dose of 4 mg given over 20 min every 2 h. The peak plasma terbutaline concentration for the intermittent nebulization treatment (INT) group (5.1 +/- 2.1 ng/ml) occurred 1 h after the fourth inhalation treatment and was similar to the peak concentration for the continuous nebulization treatment (CNT) group, which was reached at the end of the 8 h period (4.7 +/- 2.3 ng/ml). The maximum heart rate increase for the INT group (19.6 +/- 18.3 bpm) occurred 1 h after the fourth dose and was similar to the peak observed in the CNT group (19.6 +/- 19.2 bpm), which occurred after 3 h. Similar increases in systolic and decreases in diastolic pressures were observed for the INT and CNT groups. No evidence of serious adverse myocardial complications was seen in either group, as evidenced by measurements of the MB fraction of creatine phosphokinase (CPK-MB) and Holter-monitor recordings. Continuous nebulization of the terbutaline produces similar plasma concentrations and cardiovascular physiologic responses as intermittent nebulization.(ABSTRACT TRUNCATED AT 250 WORDS)

Chronic otitis media requiring ventilation tubes in tracheotomized ventilator dependent children.

The occurrence of sinusitis and middle ear effusions has frequently been attributed to the obstruction of the sinus ostia and/or eustachian tube. In the intensive care unit setting, edema caused by the irritation from nasogastric, nasotracheal and orotracheal tubes has been associated with this pathology and has been responsible for occult sepsis in this population. Our investigation was performed to determine the risk of chronic otitis media with effusion necessitating myringotomy with tympanostomy tubes among tracheotomized, ventilator dependent children in a consecutive series of children admitted to our recently created stable ventilator unit. We retrospectively reviewed the medical records of all tracheotomized, chronically ventilator dependent children < 48 months of age who had been hospitalized in this unit from the initial opening in September 1990 to January 1993. Data collected consisted of patient demographics, gestational age, cognitive abilities, age at onset of mechanical ventilation, age at tracheostomy, age at myringotomy, presence of nasogastric and gastroenterostomy tubes and evidence of gastric-esophageal reflux. All children underwent a tracheostomy procedure subsequent to the onset of mechanical ventilation. Of these patients, 9/12 (75%) later required myringotomy with tympanostomy tube placement following the occurrence of chronic otitis media with effusion. Ventilation tubes for chronic otitis media with effusion were not required in 3 patients. Using a case control study design, we examined the need of myringotomy tubes for children requiring continuous mechanical ventilation versus those requiring night-time only ventilation. The risk of myringotomy tubes in the continuously ventilated group (9/9) was significantly greater than the risk in the intermittently ventilated group (0/3) P < 0.01.(ABSTRACT TRUNCATED AT 250 WORDS)