Pre-oxygenation Methods in Bariatric Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-01

Study Completion Date

2019-10-15

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Obesity Anesthesia Bariatric Surgery Candidate

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type ACTIVE_COMPARATOR

Standard anaesthetic face mask

Intervention Type DEVICE

Oxygen delivery via an anaesthetic facemask

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

Group Type EXPERIMENTAL

Optiflow and THRIVE technique

Intervention Type DEVICE

Nasal high flow humidified oxygen

Interventions

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Optiflow and THRIVE technique

Nasal high flow humidified oxygen

Intervention Type DEVICE

Standard anaesthetic face mask

Oxygen delivery via an anaesthetic facemask

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes