Impact of tapered-cuff tracheal tube on microaspiration of gastric contents in intubated critically ill patients: a multicenter cluster-randomized cross-over controlled trial.

PURPOSE: Studies on the impact of tapered-cuff tracheal tubes on rates of microaspiration and ventilator-associated pneumonia (VAP) in intubated patients have reported conflicting results. The aim of this study was to determine the influence of this shape of tracheal cuff on abundant microaspiration of gastric contents in critically ill patients. METHODS: All patients intubated in the intensive care unit (ICU) and requiring mechanical ventilation for at least 48 h were eligible for this multicenter cluster-randomized controlled cross-over open-label study. The primary outcome was abundant microaspiration of gastric contents, defined by the presence of pepsin at significant level in >30% of tracheal aspirates. Quantitative measurement of pepsin and salivary amylase was performed in all tracheal aspirates during the 48 h following enrollment. RESULTS: A total of 326 patients were enrolled in the ten participating ICUs (162 in the PVC tapered-cuff group and 164 in the standard-cuff group). Patient characteristics were similar in the two study groups. The proportion of patients with abundant microaspiration of gastric contents was 53.5% in the tapered-cuff and 51.0% in the standard-cuff group (odds ratio 1.14, 95% CI 0.72-1.82). While abundant microaspiration of oropharyngeal secretions was not significantly different (77.4 vs 68.6%, p = 0.095), the proportion of patients with tracheobronchial colonization was significantly lower (29.6 vs 43.3%, p = 0.01) in the tapered-cuff than in the standard-cuff group. No significant difference between the two groups was found for other secondary outcomes, including ventilator-associated events and VAP. CONCLUSIONS: This trial showed no significant impact of tapered-cuff tracheal tubes on abundant microaspiration of gastric contents. TRIAL REGISTRATION: ClinicalTrials.gov, number NCT01948635.

The use of static and dynamic haemodynamic parameters before volume expansion: A prospective observational study in six French intensive care units.

OBJECTIVE: The aim of the present study was to determine the use of static and dynamic haemodynamic parameters for predicting fluid responsiveness prior to volume expansion (VE) in intensive care unit (ICU) patients with systemic inflammatory response syndrome (SIRS). METHODS: We conducted a prospective, multicentre, observational study in 6 French ICUs in 2012. ICU physicians were audited concerning their use of static and dynamic haemodynamic parameters before each VE performed in patients with SIRS for 6 consecutive weeks. RESULTS: The median volume of the 566 VEs administered to patients with SIRS was 1000mL [500-1000mL]. Although at least one static or dynamic haemodynamic parameter was measurable before 99% (95% CI, 99%-100%) of VEs, at least one them was used in only 38% (95% CI, 34%-42%) of cases: static parameters in 11% of cases (95% CI, 10%-12%) and dynamic parameters in 32% (95% CI, 30%-34%). Static parameters were never used when uninterpretable. For 15% of VEs (95% CI, 12%-18%), a dynamic parameter was measured in the presence of contraindications. Among dynamic parameters, respiratory variations in arterial pulse pressure (PPV) and passive leg raising (PLR) were measurable and interpretable before 17% and 90% of VEs, respectively. CONCLUSIONS: Haemodynamic parameters are underused for predicting fluid responsiveness in current practice. In contrast to static parameters, dynamic parameters are often incorrectly used in the presence of contraindications. PLR is more frequently valid than PPV for predicting fluid responsiveness in ICU patients.

Impact of tracheal cuff shape on microaspiration of gastric contents in intubated critically ill patients: study protocol for a randomized controlled trial.

BACKGROUND: Ventilator-associated pneumonia (VAP) is the most common infection in intubated critically ill patients. Microaspiration of the contaminated gastric and oropharyngeal secretions is the main mechanism involved in the pathophysiology of VAP. Tracheal cuff plays an important role in stopping the progression of contaminated secretions into the lower respiratory tract. Previous in vitro studies suggested that conical cuff shape might be helpful in improving tracheal sealing. However, clinical studies found conflicting results. The aim of this study is to determine the impact of conical tracheal cuff shape on the microaspiration of gastric contents in critically ill patients. METHODS/DESIGN: This prospective cluster randomized controlled crossover open-label trial is currently being conducted in ten French intensive care units (ICUs). Patients are allocated to intubation with a polyvinyl chloride (PVC) standard (barrel)-shaped or a PVC conical-shaped tracheal tube. The primary objective is to determine the impact of the conical shaped tracheal cuff on abundant microaspiration of gastric contents. Secondary outcomes include the incidence of microaspiration of oropharyngeal secretions, tracheobronchial colonization, VAP and ventilator-associated events. Abundant microaspiration is defined as the presence of pepsin at significant level (>200 ng/ml) in at least 30 % of the tracheal aspirates. Pepsin and amylase are quantitatively measured in all tracheal aspirates during the 48 h following inclusion. Quantitative tracheal aspirate culture is performed at inclusion and twice weekly. We plan to recruit 312 patients in the participating ICUs. DISCUSSION: BEST Cuff is the first randomized controlled study evaluating the impact of PVC tracheal-cuff shape on gastric microaspirations in patients receiving invasive mechanical ventilation. Enrollment began in June 2014 and is expected to end in October 2015. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT01948635 (registered 31 August 2013).