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Use of high flow nasal oxygen in bariatric surgery: a randomised controlled trial

The efficacy of Transnasal humidified Rapid-insufflation ventilator exchange (THRIVE) in obese adults: a randomised controlled trial.

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12618000445279
Enrollment
42
Registered
2018-03-28
Start date
2018-09-10
Completion date
2019-05-07
Last updated
2020-02-03

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

Conditions

None listed

Brief summary

During general anaesthesia, obese patients are at risk of oxygen levels in the blood rapidly falling when not breathing. This rapid reduction is due to the combination of reduced chest wall and diaphragmatic tone, the increased incidence of lung collapse, and secretion retention. Administering oxygen before general anaesthesia is less effective than in patients with a normal weight and obese patients pose more difficulties with airway management. Transnasal humidified Rapid-insufflation ventilator exchange (THRIVE) has recently gained popularity within anaesthetic practice due to the respiratory safety benefits it provides in patients who are not breathing. THRIVE increases the time in which patients can be not breathing before oxygen levels in the blood begin to fall. The aim of this study is to identify the safety benefits of high-flow nasal oxygen deliver (Transnasal humidified Rapid-insufflation ventilator exchange (THRIVE)) in obese patients undergoing elective bariatric surgery. It may potentially increase the time to hypoxia and increase carbon dioxide elimination in obese patients who are not breathing, who are at higher risk of lung complications.

Interventions

After manually oxygenating the patient to an end-tidal oxygen concentration (FEO2) of 0.9 via bag-mask-ventilation, oxygen will be administered via the Optiflow THRIVE device, at a flow rate of 50-70LPM as tolerated, humidified using the Fisher and Paykel 850 humidifier, to a humidity of 70% relative humidity. The oxygen concentration delivered from the device will be 100%, but the actual inspired oxygen concentration will vary with the degree of air entrainment. Pre-operatively an arterial li

After manually oxygenating the patient to an end-tidal oxygen concentration (FEO2) of 0.9 via bag-mask-ventilation, oxygen will be administered via the Optiflow THRIVE device, at a flow rate of 50-70LPM as tolerated, humidified using the Fisher and Paykel 850 humidifier, to a humidity of 70% relative humidity. The oxygen concentration delivered from the device will be 100%, but the actual inspired oxygen concentration will vary with the degree of air entrainment. Pre-operatively an arterial line will be inserted for baseline and post-apnoea arterial blood gas analysis and blood pressure measurement. Arterial line insertion and invasive blood pressure monitoring is current practice in our institution in the management of an obese patient due to the lack of reliability of non-invasive blood pressure measurements in this population. Additionally, the use of an arterial line allows for repeated blood samples to be taken without exposing the patient to repeated skin puncture. Induction of anaesthesia will be conducted with alfentanil or fentanyl, propofol and rocuronium 1mg/kg of calculated lean body weight. Maintenance of anaesthesia during the period of data collection will be via intravenous propofol infusion. The patient will be ventilated with bag mask ventilation and the treating anaesthetist will perform gentle laryngoscopy with a CMAC video laryngoscope when the patient is pharmacologically paralysed. Laryngoscopy will take approximately 60 seconds. If the patient is judged to be an easy bag-mask ventilation and Cormack-Lehane laryngoscopy grade I or II, the laryngoscope will be removed and the patient will be bag-mask ventilated to an end-tidal oxygen of 90%. Once this target it reached, Optiflow THRIVE will be applied to the patient, an adequately sized an oropharyngeal airway inserted and airway manoeuvres (chin lift, head tilt, jaw thrust) performed to ensure airway patency. The patient will remain anaesthetised and apnoeic until an SpO2 of 95% or a time of six minutes is reached. At this point Optiflow THRIVE will be removed and the patient manually bag mask ventilated until SpO2 of 98% is achieved, and the patient will be intubated. During the period of apnoeic oxygenation, anaesthesia will be maintained with a propofol infusion. The intervention will only be performed once during the trial, for a maximum time period of 6 minutes. The procedure will be performed by a specialist anaesthetist with at least 5 years of anaesthetic experience, or by an anaesthetic trainee with a consultant anaesthetist present. The trial will occur at a tertiary hospital. The trial will be performed under direct supervision by the research practitioner in order to ensure that the intervention and control groups are being adhered to.

Sponsors

Royal Brisbane and Women's 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
Yes

Inclusion criteria

- Patients aged >18 years - BMI >35 kg/m2 - Scheduled for elective bariatric surgery - Written informed consent by the patient

Exclusion criteria

- ASA physical status greater than or equal to 4 - Severe respiratory pathology - Pulmonary hypertension - Cormack-Lehane Laryngoscopy grade equal to 3 at the time of intraoperative laryngoscopy - Difficulty with bag-mask-ventilation after induction of anaesthesia - Pregnant patients - Inability to obtain written informed consent

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026