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

Sponsor
St George's, University of London (Other)
Overall Status
Unknown status
CT.gov ID
NCT02777840
Collaborator
(none)
80
Enrollment
1
Location
2
Arms
36
Anticipated Duration (Months)
2.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

High flow oxygen results in better oxygenation in emergency cases needing rapid sequence induction for anaesthesia. Secondary outcome measure is time for any desaturation.

Condition or Disease Intervention/Treatment Phase
  • Device: face mask oxygen
  • Device: High flow oxygen
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
80 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
High Flow Oxygen With THRIVE Gives Better Oxygenation in Rapid Sequence Induction Patients
Actual Study Start Date :
Mar 1, 2015
Anticipated Primary Completion Date :
Mar 1, 2018
Anticipated Study Completion Date :
Mar 1, 2018

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Oxygen levels in blood gas sample [intraoperative]

    Oxygen levels in blood gas sample after the airway is secured

Secondary Outcome Measures

  1. time to desaturation [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.

  2. heart rate of anaesthetist performing the intubation [During the process of induction of anaesthesia and intubation upto 5 minutes post intubation]

Eligibility Criteria

Criteria

Ages Eligible for Study:
16 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 St Georges Hospital NHS Trust London United Kingdom sw17 0qt

Sponsors and Collaborators

  • St George's, University of London

Investigators

  • Principal Investigator: Fauzia Mir, St Georges hospital NHS trust

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
St George's, University of London
ClinicalTrials.gov Identifier:
NCT02777840
Other Study ID Numbers:
  • 15/LO/0277
First Posted:
May 19, 2016
Last Update Posted:
Oct 5, 2017
Last Verified:
Oct 1, 2017
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes

Study Results

No Results Posted as of Oct 5, 2017