NCT02694705

Brief Summary

Comparison of the preoxygenation efficacy of tidal volume breathing using three different preoxygenation techniques which are available to providers in the prehospital environment.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2016

Shorter than P25 for not_applicable

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

Study Start

First participant enrolled

February 1, 2016

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

February 24, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 29, 2016

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

September 30, 2016

Status Verified

September 1, 2016

Enrollment Period

5 months

First QC Date

February 24, 2016

Last Update Submit

September 29, 2016

Conditions

Keywords

Oxygen Inhalation TherapyIntubationEmergency Medicine

Outcome Measures

Primary Outcomes (1)

  • Fractional Expired Oxygen Concentration

    Measure of denitrogenation efficacy

    3 minutes

Secondary Outcomes (1)

  • Ease of breathing assessment using a visual analogue scale

    3 minutes

Study Arms (3)

CPAP

EXPERIMENTAL

3 minutes of preoxygenation with a portable ventilator providing Continuous Positive Airway Pressure (CPAP) at 5 cmH20 and an FiO2 of 100%.

Device: Continuous Positive Airway Pressure (CPAP)

BVM

EXPERIMENTAL

3 minutes of preoxygenation with a bag-valve-mask (BVM) device and oxygen flow rate of 15 litres / minute.

Device: Bag-Valve-Mask (BVM)

NRM

EXPERIMENTAL

3 minutes of preoxygenation with a non-rebreather mask (NRM) device and oxygen flow rate of 15 litres / minute.

Device: Non-rebreather Mask (NRM)

Interventions

CPAP provided by a portable Draeger Oxylog® 3000 plus ventilator

CPAP

Preoxygenation provided by BVM device, oxygen flow rate 15 l/min

BVM

Preoxygenation provided by NRM, oxygen flow rate 15 l/min

NRM

Eligibility Criteria

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

You may qualify if:

  • Adult volunteers

You may not qualify if:

  • Pregnancy
  • Respiratory disease
  • Bearded
  • Facial abnormality
  • Edentulous

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Essex & Herts Air Ambulance Trust

Earls Colne, Essex, CO6 2NS, United Kingdom

Location

Related Publications (1)

  • Groombridge C, Chin CW, Hanrahan B, Holdgate A. Assessment of Common Preoxygenation Strategies Outside of the Operating Room Environment. Acad Emerg Med. 2016 Mar;23(3):342-6. doi: 10.1111/acem.12889. Epub 2016 Feb 17.

    PMID: 26728311BACKGROUND

MeSH Terms

Conditions

Hypoxia

Interventions

Continuous Positive Airway Pressure

Condition Hierarchy (Ancestors)

Signs and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Positive-Pressure RespirationRespiration, ArtificialAirway ManagementTherapeuticsRespiratory Therapy

Study Officials

  • Christopher J Groombridge, MBBS

    Queen Mary University of London

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

February 24, 2016

First Posted

February 29, 2016

Study Start

February 1, 2016

Primary Completion

July 1, 2016

Study Completion

July 1, 2016

Last Updated

September 30, 2016

Record last verified: 2016-09

Data Sharing

IPD Sharing
Will not share

Locations