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Prophylactic post-operative high flow nasal oxygen therapy versus conventional oxygen therapy in obese patients undergoing bariatric surgery: a randomised controlled pilot study

Prophylactic post-operative high flow nasal oxygen therapy versus conventional oxygen therapy in obese patients undergoing bariatric surgery: a randomised controlled pilot study

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12617000694314
Acronym
OXYBAR High flow nasal OXYgen after BARiatric surgery
Enrollment
64
Registered
2017-05-15
Start date
2017-04-03
Completion date
2017-09-30
Last updated
2017-05-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Obesity, defined as a body mass index (BMI) > 30 kg/m2, has almost doubled since 1980, with more than 671 million people worldwide now classified as obese. Health problems associated with obesity impact on quality of life and impose a significant cost burden to the health service. The total financial cost of obesity is estimated to be $8.3 billion. Obesity is difficult to treat. Diet, exercise and medications being only modestly effective in aiding weight loss. In selected individual’s, bariatric surgery may offer a means of achieving long-term weight loss, improved health and cost reduction. The physiological and pathological changes that arise from obesity predispose to post-operative respiratory complications. Excess pressure exerted by an increased amount of fat tissue on the chest wall and in the abdomen, leads to collapse and closure of small airways within the lungs. This collapse of the small airways is worsened still by general anaesthesia and lying flat both of which are a requirement for surgery. This collapse persists longer into the postoperative period in the obese when compared to the non-obese population. High flow nasal oxygen therapy (HFN02) has been established as treatment for respiratory failure in infants and neonates. Its use has also become more prevalent in the adult population over the last decade, with an expanding list of clinical applications. High flow nasal cannula (HFNC) are designed to deliver a predetermined amount of heated and humidified oxygen to a patient. HFNC deliver oxygen at a much higher flow rate than a conventional face mask or nasal cannula, up to 70L/min vs 6L/min. The use of high flow nasal oxygen (HFN02) has been shown to improve the clearance of mucus from the airways, reduce the amount of energy used to breath, deliver a more accurate and reliable amount of oxygen to the lungs, and provide a degree of positive pressure into the lungs. The provision of positive pressure has been shown to increase the lung volume, this suggests that small airways that were previously closed are splinted open by the pressure provided. All of the positive effects of HFN02 outlined above are of potential benefit to obese patients in the postoperative period. Of particular interest is the provision of positive pressure which helps open up collapsed small airways. By carrying out our proposed study we hope to determine the impact that HFN02 has on postoperative lung volumes when compared to standard oxygen therapy. Lung volumes, specifically end expiratory lung volume (EELV) can be measured using electrical impedance tomography (EIT). EIT is a radiation free functional imaging modality invented over 30 years ago. It is non-invasive and can be used in real time at the patient’s bedside to assess lung volume changes. EIT has been successful validated against a number of other imagining and measurement modalities. It consists of 16 paired electrodes attached to a belt that is placed around the patient’s chest usually between the 4th/5th or 5th/6th rib. It then feeds back information about the patient’s volumes lungs as they breath to a computer for analysis. Both numerical measurements and images are produced. Hypotheses In obese, adult patients, undergoing laparoscopic surgery for weight reduction, prophylactic post-operative HFN02 therapy will increase EELV, improve respiratory function and reduce respiratory morbidity in the post-operative period

Interventions

Pre-operative management of the patient will be consistent with current surgical best practice and at the discretion of the responsible surgeon. The method and conduct of general anaesthesia will be at the discretion of the responsible anaesthetist. Given the nature of the surgery, all patients will undergo endotracheal intubation and mechanical ventilation. Extubation will occur in theatre and all patients (control and intervention) will receive 6l of oxygen via Hudson face mask. They will th

Pre-operative management of the patient will be consistent with current surgical best practice and at the discretion of the responsible surgeon. The method and conduct of general anaesthesia will be at the discretion of the responsible anaesthetist. Given the nature of the surgery, all patients will undergo endotracheal intubation and mechanical ventilation. Extubation will occur in theatre and all patients (control and intervention) will receive 6l of oxygen via Hudson face mask. They will then be transferred to the ICU. Baseline measurements will be undertaken when the patient has achieved a Richmond agitation and sedation score (RASS) of -2 or greater. After baseline measurements have been recorded patients randomised to the intervention group will be managed with supplemental oxygen delivered at a FiO2 of 0.5 and a flow rate of 50 L/min via the Airvo (Trademark) 2 High Flow Nasal Oxygen device (Fisher & Paykel, New Zealand). Oxygen therapy will be titrated to maintain peripheral oxygen saturations (SpO2) =95%. This will be achieved by increasing or decreasing the FiO2 delivered. A constant flow rate of 50 L/min should be maintained for the duration of the study period. The study period will last for 6 hours following initation of HFN02.

Sponsors

St Andrews War Memorial Hospital
Lead SponsorHospital

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Age >18 yrs BMI >32 kg/m2 Undergoing a laparoscopic bariatric procedure for weight reduction

Exclusion criteria

Age <18 yrs Refusal of informed consent Any contraindication to HFN02 therapy (see below) Chest circumference too large for EIT belt (Chest > 75cm in diameter from left to right mid-axillae) Contraindications to HFN02 Epistaxis Significant facial trauma Base of skull fracture Nasal obstruction; e.g. nasal fracture, tenacious secretions, tumour

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 23, 2026