High Flow Oxygen With THRIVE Gives Better Oxygenation in Rapid Sequence Induction Patients (THRIVE/RSI 1)

October 3, 2017 updated by: St George's, University of London
High flow oxygen results in better oxygenation in emergency cases needing rapid sequence induction for anaesthesia. Secondary outcome measure is time for any desaturation.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The investigators intend to do the study using high flow oxygen for all emergency cases needing rapid sequence induction. As part of the study the Investigators will measure the oxygen levels in the blood gas sample of the patient and the heart rate of anesthetist in charge of the airway management. After the airway is secured the time for desaturation will be noted.

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Emergency patients needing rapid sequence induction for surgery
  • ≥ 16 years
  • Able to give consent

Exclusion Criteria:

  • Patients age under 16 years
  • Inability to give consent
  • Severe respiratory disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Face mask group
Patients will be given oxygen via face mask as per routine practice, blood gas sample taken after airway is secured, heart rate of anaesthetist monitored and time for desaturation noted.
Device: face mask oxygen
oxygen given by face mask as per routine practice
Active Comparator: THRIVE group
Patients will be given oxygen via high flow oxygen in Optiflo, blood gas sample taken after airway is secured, heart rate of anaesthetist monitored and time for desaturation noted.
Device: High flow oxygen
High flow oxygen given via optiflo machine / device

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oxygen levels in blood gas sample
Time Frame: intraoperative
Oxygen levels in blood gas sample after the airway is secured
intraoperative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
time to desaturation
Time Frame: intraoperative or 10 minutes after intubation
after airway is secured time will be noted for oxygen levels to fall to 92% before the ventilation is started.
intraoperative or 10 minutes after intubation
heart rate of anaesthetist performing the intubation
Time Frame: During the process of induction of anaesthesia and intubation upto 5 minutes post intubation
During the process of induction of anaesthesia and intubation upto 5 minutes post intubation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

St George's, University of London

Investigators

  • Principal Investigator: Fauzia Mir, St Georges Hospital NHS Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2015

Primary Completion (Anticipated)

March 1, 2018

Study Completion (Anticipated)

March 1, 2018

Study Registration Dates

First Submitted

May 13, 2016

First Submitted That Met QC Criteria

May 18, 2016

First Posted (Estimate)

May 19, 2016

Study Record Updates

Last Update Posted (Actual)

October 5, 2017

Last Update Submitted That Met QC Criteria

October 3, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • 15/LO/0277

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

As per guidelines

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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