NCT02777840

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

March 1, 2015

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

May 13, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 19, 2016

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2018

Completed
Last Updated

October 5, 2017

Status Verified

October 1, 2017

Enrollment Period

3 years

First QC Date

May 13, 2016

Last Update Submit

October 3, 2017

Conditions

High Flow Oxygen in Rapid Sequence InductionAirway Morbidity

Outcome Measures

Primary Outcomes (1)

  • Oxygen levels in blood gas sample

    Oxygen levels in blood gas sample after the airway is secured

    intraoperative

Secondary Outcomes (2)

  • time to desaturation

    intraoperative or 10 minutes after intubation

  • heart rate of anaesthetist performing the intubation

    During the process of induction of anaesthesia and intubation upto 5 minutes post intubation

Study Arms (2)

Face mask group

ACTIVE COMPARATOR

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

THRIVE group

ACTIVE COMPARATOR

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

Interventions

face mask oxygenDEVICE

oxygen given by face mask as per routine practice

Face mask group
High flow oxygenDEVICE

High flow oxygen given via optiflo machine / device

THRIVE group

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St Georges Hospital NHS Trust

London, sw17 0qt, United Kingdom

RECRUITING

Study Officials

  • Fauzia Mir

    St Georges hospital NHS trust

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lucy Parker

CONTACT

0208 266 6397lparker@sgul.ac.uk

Study Design

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

Study Record Dates

First Submitted

May 13, 2016

First Posted

May 19, 2016

Study Start

March 1, 2015

Primary Completion

March 1, 2018

Study Completion

March 1, 2018

Last Updated

October 5, 2017

Record last verified: 2017-10

Data Sharing

IPD Sharing
Will share

As per guidelines

Locations

GB(1)