Prophylactic Postoperative High Flow Nasal Oxygen Versus Conventional Oxygen Therapy in Obese Patients Undergoing Bariatric Surgery (OXYBAR Study): a Pilot Randomised Controlled Trial.

BACKGROUND: Patients with obesity are predisposed to a reduction in end-expiratory lung volume (EELV) and atelectasis after anaesthesia. High flow nasal oxygen (HFNO) may increase EELV, reducing the likelihood of postoperative pulmonary complications (PPC). We conducted a pilot randomised controlled trial (RCT) of conventional oxygen therapy versus HFNO after bariatric surgery. The aim was to investigate the feasibility of using electrical impedance tomography (EIT) as a means of assessing respiratory mechanics and to inform the design of a definitive RCT. METHODS: We performed a single-centre, parallel-group, pilot RCT. Adult patients with obesity undergoing elective bariatric surgery were eligible for inclusion. We excluded patients with a known contraindication to HFNO or with chronic lung disease. RESULTS: Fifty patients were randomised in equal proportions. One patient crossed over from conventional O2 to HFNO. Delta EELI was higher at 1 hour in patients receiving HFNO (mean difference = 831 Au (95% CI - 1636-3298), p = 0.5). Continuous EIT beyond 1 hour was poorly tolerated. At 6 hours, there were no differences in PaO2/FiO2 ratio or PaCO2. Only one patient developed a PPC (in the HFNO group) by 6 weeks. CONCLUSIONS: These data suggest that a large-scale RCT of HFNO after bariatric surgery in an 'all-comers' population is likely infeasible. While EIT was an effective means of assessing respiratory mechanics, it was impractical over time. Similarly, the infrequency of PPC precludes its use as a primary outcome. Future studies should focus on identifying patients at the greatest risk of PPC.

Bleeding Management Practices of Australian Cardiac Surgeons, Anesthesiologists and Perfusionists: A Cross-Sectional National Survey Incorporating the Theoretical Domains Framework (TDF) and COM-B Model.

PURPOSE: Excessive bleeding is an acknowledged consequence of cardiac surgery, occurring in up to 10% of adult patients. This clinically important complication leads to poorer patient outcomes. Clinical practice guidelines are available to support best practice however variability in bleeding management practice and related adverse outcomes still exist. This study had two objectives: 1) to gain insight into current bleeding management practice for adult cardiac surgery in Australia and how that compared to guidelines and literature; and 2) to understand perceived difficulties clinicians face implementing improvements in bleeding management. METHODS: A national cross-sectional questionnaire survey was utilized. Perspectives were sought from cardiac surgeons, cardiac anesthesiologists and perfusionists. Thirty-nine closed-ended questions focused on routine bleeding management practices to address pre and intra-operative care. One open-ended question was asked; "What would assist you to improve bleeding management with cardiac surgery patients?" Quantitative data were analysed with SPSS. Qualitative data were categorized into the domains of the Theoretical Domains Framework; the domains were then mapped to the COM-B model. RESULTS: Survey responses from 159 Anesthesiologists, 39 cardiac surgeons and 86 perfusionists were included (response rate 37%). Four of the recommendations queried in this survey were reported as routinely adhered to < 50% of the time, 9 queried recommendations were adhered to 51-75% of the time and 4 recommendations were routinely followed >76% of the time. CONCLUSION: There is a wide variation in peri-operative bleeding management practice among cardiac anaesthesiologists, surgeons and perfusionists in Australian cardiac surgery units. Conceptualizing factors believed necessary to improve practice with the TDF and COM-B model found that bleeding management could be improved with a standardized approach including; point of care diagnostic assays, a bleeding management algorithm, access to concentrated coagulation factors, cardiac surgery specific bleeding management education, multidisciplinary team agreement and support, and an overarching national approach.

A randomized, controlled pilot clinical trial of cryopreserved platelets for perioperative surgical bleeding: the CLIP-I trial (Editorial, p. 2759).

BACKGROUND: Cryopreservation extends platelet (PLT) shelf life from 5 to 7 days to 2 to 4 years. However, only 73 patients have been transfused cryopreserved PLTs in published randomized controlled trials (RCTs), making safety data insufficient for regulatory approval. STUDY DESIGN AND METHODS: The Cryopreserved vs. Liquid Platelet (CLIP) study was a double-blind, pilot, multicenter RCT involving high-risk cardiothoracic surgical patients in four Australian hospitals. The objective was to test, as the primary outcome, the feasibility and safety of the protocol. Patients were allocated to study group by permuted block randomization, with patients and clinicians blinded by use of an opaque shroud placed over each study PLT unit. Up to 3 units of cryopreserved or liquid-stored PLTs were administered per patient. No other aspect of patient care was affected. Adverse events were actively sought. RESULTS: A total of 121 patients were randomized, of whom 23 received cryopreserved PLTs and 18 received liquid-stored PLTs. There were no differences in blood loss (median, 715 mL vs. 805 mL at 24 hr; difference between groups 90 mL [95% CI, -343.8 to 163.8 mL], p = 0.41), but the Bleeding Academic Research Consortium criterion for significant postoperative hemorrhage in cardiac surgery composite bleeding endpoint occurred in nearly twice as many patients in the liquid-stored group (55.6% vs. 30.4%, p = 0.10). Red blood cell transfusion requirements were a median of 3 units in the cryopreserved group versus 4 units with liquid-stored PLTs (difference between groups, 1 unit [95% CI, -3.1 to 1.1 units]; p = 0.23). Patients in the cryopreserved group were more likely to be transfused fresh-frozen plasma (78.3% vs. 27.8%, p = 0.002) and received more study PLT units (median, 2 units vs. 1 unit; difference between groups, 1 unit [95% CI, -0.03 to 2.0 units]; p = 0.012). There were no between-group differences in potential harms including deep venous thrombosis, myocardial infarction, respiratory function, infection, and renal function. No patient had died at 28 days, and postoperative length of stay was similar in each group. CONCLUSION: In this pilot RCT, compared to liquid-stored PLTs, cryopreserved PLTs were associated with no evidence of harm. A definitive study testing safety and hemostatic effectiveness is warranted.

High flow nasal oxygen after bariatric surgery (OXYBAR), prophylactic post-operative high flow nasal oxygen versus conventional oxygen therapy in obese patients undergoing bariatric surgery: study protocol for a randomised controlled pilot trial.

BACKGROUND: The incidence of obesity is increasing worldwide. In selected individuals, bariatric surgery may offer a means of achieving long-term weight loss, improved health, and healthcare cost reduction. Physiological changes that occur because of obesity and general anaesthesia predispose to respiratory complications following bariatric surgery. The aim of this study is to determine whether post-operative high flow nasal oxygen therapy (HFNO2) improves respiratory function and reduces the incidence of post-operative pulmonary complications (PPCs) in comparison to conventional oxygen therapy in these patients. METHOD: The OXYBAR study is a prospective, un-blinded, single centre, randomised, controlled pilot study. Patients with body mass index (BMI) > 30 kg/m2, undergoing laparoscopic bariatric surgery, will be randomised to receive either standard low flow oxygen therapy or HFNO2 in the post-operative period. The primary outcome measure is the change in end expiratory lung impedance (∆EELI) as measured by electrical impedance tomography (EIT). Secondary outcome measures include change in tidal volume (∆Vt), partial arterial pressure of oxygen/fraction of inspired oxygen (PaO2/FiO2) ratio, incidence of PPCs, hospital length of stay and measures of patient comfort. DISCUSSION: We hypothesise that the post-operative administration of HFNO2 will increase EELI and therefore end expiratory lung volume (EELV) in obese patients. To our knowledge this is the first trial designed to assess the effects of HFNO2 on EELV in this population. We anticipate that data collected during this pilot study will inform a larger multicentre trial. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry (ANZCTR), ACTRN12617000694314 . Registered on 15 May 2017.

Targeted Bleeding Management Reduces the Requirements for Blood Component Therapy in Lung Transplant Recipients.

OBJECTIVE: Lung transplantation is associated with high rates of bleeding and frequent blood transfusion. The authors aimed to determine if point-of-care coagulation testing (POCCT) reduced transfusion requirements. DESIGN, SETTINGS, AND PARTICIPANTS: A before-and-after cohort analysis conducted at a single tertiary referral center. Ninety-three sequential adult patients between January 2010 and January 2014 undergoing isolated lung transplant without preoperative extracorporeal support were analyzed. INTERVENTION: ROTEM and multi-plate POCCT were introduced on July 1, 2012, with an associated algorithm based on the results. MEASUREMENTS AND MAIN RESULTS: Statistically significant decreases in the proportion of patients receiving PRBCs (87% v 65%; p = 0.015), FFP (72% v 30%; p<0.0001) and platelets (70% v 37%; p = 0.002) were found after the intervention. There were small decreases in median chest tube blood loss at 2 hours (300 mLs v 215 mLs; p = 0.03) and 4 hours (440 mLs v 350 mLs; p = 0.050) but not at 12 hours postoperatively. There were no changes in reoperation for bleeding (9% v 4%; p = 0.158) or in-hospital mortality (6% v 2%; p = 0.617). The cost of blood products administered decreased from a median of $3,935.00 to $991.00 (p<0.001). CONCLUSIONS: Use of POCCT in lung-transplant surgery is associated with significant reductions in blood product use and cost. There were no detectable changes in outcome aside from a small decrease in early postoperative bleeding.