NCT03428256

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable obesity

Timeline
Completed

Started Oct 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 27, 2017

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 9, 2018

Completed
8 months until next milestone

Study Start

First participant enrolled

October 1, 2018

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2019

Completed
Last Updated

October 18, 2019

Status Verified

October 1, 2019

Enrollment Period

1 year

First QC Date

November 27, 2017

Last Update Submit

October 16, 2019

Conditions

ObesityAnesthesiaBariatric Surgery Candidate

Keywords

ObesityBariatric Surgery

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • The correlation between Oxygen Reserve Index (ORI) and pre-oxygenation with either a standard anaesthetic face mask or the THRIVE technique.

    Eighteen (18) minutes maximum

Study Arms (2)

Pre-oxygenation with a standard anaesthetic face mask

ACTIVE COMPARATOR

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

Pre-oxygenation using Optiflow and THRIVE technique

EXPERIMENTAL

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

Interventions

Optiflow and THRIVE techniqueDEVICE

Nasal high flow humidified oxygen

Pre-oxygenation using Optiflow and THRIVE technique
Standard anaesthetic face maskDEVICE

Oxygen delivery via an anaesthetic facemask

Pre-oxygenation with a standard anaesthetic face mask

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St Mary's Hospital

London, United Kingdom

Location

Related Publications (1)

  • 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.

    PMID: 35027169DERIVED

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Jonathan Cousins, FRCA FFICM

    Imperial College Healthcare

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 27, 2017

First Posted

February 9, 2018

Study Start

October 1, 2018

Primary Completion

October 15, 2019

Study Completion

October 15, 2019

Last Updated

October 18, 2019

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)