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Pre-oxygenation Methods in Bariatric Patients

Primary Purpose

Obesity, Anesthesia, Bariatric Surgery Candidate

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Optiflow and THRIVE technique
Standard anaesthetic face mask
Sponsored by
Imperial College London
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring Obesity, Bariatric Surgery

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • St Mary's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Pre-oxygenation with a standard anaesthetic face mask

Pre-oxygenation using Optiflow and THRIVE technique

Arm Description

Pre-oxygenation delivered in the standard way; 3 minutes, Fraction of inspired oxygen (FiO2) 1.0, 8 vital capacity breaths in the last minute

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
November 27, 2017
Last Updated
October 16, 2019
Sponsor
Imperial College London
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1. Study Identification

Unique Protocol Identification Number
NCT03428256
Brief Title
Pre-oxygenation Methods in Bariatric Patients
Official Title
A Randomised Controlled Comparison of Effectiveness of Facemask Preoxygenation and Transnasal Humidified Rapid-Insufflation Ventilatory Exchange (THRIVE) in Bariatric Patients Undergoing General Anaesthesia
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
October 1, 2018 (Actual)
Primary Completion Date
October 15, 2019 (Actual)
Study Completion Date
October 15, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Imperial College London

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Anesthesia, Bariatric Surgery Candidate
Keywords
Obesity, Bariatric Surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pre-oxygenation with a standard anaesthetic face mask
Arm Type
Active Comparator
Arm Description
Pre-oxygenation delivered in the standard way; 3 minutes, Fraction of inspired oxygen (FiO2) 1.0, 8 vital capacity breaths in the last minute
Arm Title
Pre-oxygenation using Optiflow and THRIVE technique
Arm Type
Experimental
Arm Description
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
Intervention Type
Device
Intervention Name(s)
Optiflow and THRIVE technique
Intervention Description
Nasal high flow humidified oxygen
Intervention Type
Device
Intervention Name(s)
Standard anaesthetic face mask
Intervention Description
Oxygen delivery via an anaesthetic facemask
Primary Outcome Measure Information:
Title
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.
Description
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.
Time Frame
Eighteen (18) minutes maximum
Secondary Outcome Measure Information:
Title
The correlation between Oxygen Reserve Index (ORI) and pre-oxygenation with either a standard anaesthetic face mask or the THRIVE technique.
Description
The investigators will simultaneously record the ORI. The ORI readings will then be correlated with the SpO2 and arterial oxygen content.
Time Frame
Eighteen (18) minutes maximum

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jonathan Cousins, FRCA FFICM
Organizational Affiliation
Imperial College Healthcare
Official's Role
Principal Investigator
Facility Information:
Facility Name
St Mary's Hospital
City
London
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35027169
Citation
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. 2023 Jan;130(1):103-110. doi: 10.1016/j.bja.2021.12.011. Epub 2022 Jan 11.
Results Reference
derived

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Pre-oxygenation Methods in Bariatric Patients

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