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.

Evaluation of latest viscoelastic coagulation assays in the transcatheter aortic valve implantation setting.

BACKGROUND: Point of care viscoelastic measures with thromboelastography (TEG; Haemonetics Corporation, Switzerland) and thromboelastometry (ROTEM, Tem Innovations GmbH, Germany) now supersede laboratory assays in the perioperative assessment and management of coagulation. To the best of our knowledge, this sophisticated coagulation assessment has not been performed to characterise thrombotic changes in the transcatheter aortic valve implantation (TAVI) setting, nor have the two latest iteration cartridge-based systems been directly compared in the elective perioperative period. METHODS: Patients undergoing TAVI were prospectively recruited. Samples (n=44) were obtained at four timepoints (postinduction of anaesthesia, postheparin (100 IU/kg), postprotamine (1 mg/100 IU heparin) and 6 hours postoperatively). Each sample was concurrently assessed with standard laboratory tests (prothrombin time/international normalised ratio, activated partial thromboplastin time, thrombin clotting time, platelet count and direct fibrinogen, ROTEMSigma and TEG6s). RESULTS: Clot strength showed a statistically significant increase postheparin/TAVI deployment. When considering the subgroup of samples taken following the administration heparin, the heparinase channel of the TEG6s did not yield clotting strength results in 55% of samples and clotting time exceeded the upper limit of normal in 70% of samples. It was retrospectively recognised that the arachidonic acid channel of the TEG6s Platelet Mapping Cartridge had been decommissioned prohibiting assessment of aspirin effect. CONCLUSIONS: This study demonstrated a small intraprocedural prothrombotic change of uncertain clinical importance during the transcatheter aortic valve procedure. Further comparison with percutaneous coronary intervention and aortic valve replacement cohorts are needed to assess the merits of current antithrombotic guidelines, which are extrapolated from the PCI setting. The heparin effect was more consistently quantified by ROTEM.

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.