Pre-oxygenation Methods in Bariatric Patients

A Randomised Controlled Comparison of Effectiveness of Facemask Preoxygenation and Transnasal Humidified Rapid-Insufflation Ventilatory Exchange (THRIVE) in Bariatric Patients Undergoing General Anaesthesia

The purpose of the study is to compare effectiveness of different methods of achieving pre-oxygenation in bariatric patients. The investigators intend to compare facemask pre-oxygenation with a high-flow humidified nasal oxygen.

The primary outcome measure of interest is time to desaturation to 92% or 18 minutes of apnoea.

Study Overview

• Status: Completed
• Conditions: Obesity; Bariatric Surgery Candidate; Anesthesia
• Intervention / Treatment: Device: Standard anaesthetic face mask; Device: Optiflow and THRIVE technique

Detailed Description

General anaesthesia involves giving patients anaesthetic and muscle relaxant medications to allow transition to sleep and airway relaxation to permit laryngoscopy, respectively. During laryngoscopy, a breathing tube is placed to 'secure' the airway. There is therefore a length of time from administration of these medications to when the breathing tube is placed, when the patient is not breathing and the airway is not secured. This time is known as apnoea time. In a patient who is not breathing, blood oxygen levels fall to dangerously-low levels, within 1-2 minutes. In order to prevent this, patients breathe 100% oxygen before induction of anaesthesia as part of a process known as pre-oxygenation. There are different ways of delivering pre-oxygenation, but the common aim is to increase the oxygen reservoir within the lungs to give the anaesthetist more time to place the breathing tube. With good pre-oxygenation, apnoea times of up to 7 minutes are possible.

Apnoea time is a potentially hazardous period during induction of anaesthesia and it is particularly so in patients with severe obesity. On the one hand, obesity makes the upper airway anatomy difficult, and on the other hand, lung collapse (atelectasis) caused by abdominal contents compressing the base of the lungs reduces the amount of oxygen available within the lungs. Apnoea time can be as short of 30 seconds. Identifying the most effective method of pre-oxygenating bariatric patients can therefore significantly improve the safety of delivering general anaesthesia to these patients.

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom
    • St Mary's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 76 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Able to provide informed consent.
• Undergoing general anaesthesia .
• Between the ages of 18 and 80 years.
• Body mass index (BMI) greater than 40 Kgm-2.

Exclusion Criteria:

• Unable to give informed consent.
• Significant cardiac history which is defined as current angina, myocardial infarction <12 months before the date of the procedure.
• Significant peripheral vascular disease defined as claudication on minimal exertion or Ankle-Brachial index of <0.7, a stroke or a transient ischaemic attack <12 months before the procedure.
• Presence of significant heart-valve disease or congestive heart failure.
• Significant lower respiratory disease including brittle asthma; chronic obstructive pulmonary disease (GOLD stages 3 or 4).
• Strong predictors of both difficult intubation and difficult facemask ventilation on anaesthetic airway assessment.
• Patient with American Society of Anesthesiologists (ASA) grade of 4 for any reason.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Pre-oxygenation with a standard anaesthetic face mask; Pre-oxygenation delivered in the standard way; 3 minutes, Fraction of inspired oxygen (FiO2) 1.0, 8 vital capacity breaths in the last minute	Device: Standard anaesthetic face mask; Oxygen delivery via an anaesthetic facemask
Experimental: Pre-oxygenation using Optiflow and THRIVE technique; Pre-oxygenation delivered via nasal high flow humidified oxygen (Optiflow) and THRIVE technique. Gradually increased to 70 litres/minute, mouth closed, 8 vital capacity breaths in the last minute	Device: Optiflow and THRIVE technique; Nasal high flow humidified oxygen

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Following the induction of general anaesthesia and muscle relaxation, the time (minutes and seconds) to peripheral oxygen saturations (SpO2) of 92%. Comparing pre-oxygenation with standard face mask oxygen or THRIVE technique.	Pre-oxygenation is delivered either by a standard anaesthetic face mask or the THRIVE technique. General anaesthesia is induced and muscle relaxation is given. The time for the peripheral oxygen saturations (SpO2) to fall to 92% is recorded. When this occurs the trial is stopped and the patient is intubated. If 18 minutes is reached before SpO2 = 92% then the trial is stopped.	Eighteen (18) minutes maximum

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The correlation between Oxygen Reserve Index (ORI) and pre-oxygenation with either a standard anaesthetic face mask or the THRIVE technique.	The investigators will simultaneously record the ORI. The ORI readings will then be correlated with the SpO2 and arterial oxygen content.	Eighteen (18) minutes maximum

Collaborators and Investigators

• Sponsor: Imperial College London
• Investigators: Principal Investigator: Jonathan Cousins, FRCA FFICM, Imperial College Healthcare

Publications and helpful links

General Publications

• Schutzer-Weissmann J, Wojcikiewicz T, Karmali A, Lukosiute A, Sun R, Kanji R, Ahmed AR, Purkayastha S, Brett SJ, Cousins J. Apnoeic oxygenation in morbid obesity: a randomised controlled trial comparing facemask and high-flow nasal oxygen delivery. Br J Anaesth. 2022 Jan 11:S0007-0912(21)00800-X. doi: 10.1016/j.bja.2021.12.011. Online ahead of print.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2018
• Primary Completion (Actual): October 15, 2019
• Study Completion (Actual): October 15, 2019

Study Registration Dates

• First Submitted: November 27, 2017
• First Submitted That Met QC Criteria: February 8, 2018
• First Posted (Actual): February 9, 2018

Study Record Updates

• Last Update Posted (Actual): October 18, 2019
• Last Update Submitted That Met QC Criteria: October 16, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: Obesity; Bariatric Surgery
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics
• Other Study ID Numbers: 17SM3844

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No