Condition category
Respiratory
Date applied
17/08/2012
Date assigned
20/09/2012
Last edited
06/10/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
The goal of oxygen therapy is to treat or prevent hypoxemia (low concentration of oxygen in the blood). Many different devices can be used to achieve this goal in spontaneously breathing patients. In intensive care unit (ICU) patients, high flow devices provide oxygen at flow rates high enough to completely satisfy the patient’s needs. High flow oxygen therapy is provided by various techniques. The aim of this study is to compare three commonly used oxygen therapy devices (Optiflow™, Boussignac™, and standard facemask with a reservoir bag) to see whether they provide different levels of oxygen, airway pressure, and breathing comfort for the same oxygen flow.

Who can participate?
Patients aged 18 and over who are in the intensive care unit being treated with a tracheostomy tube to help them breathe

What does the study involve?
After their tracheostomy tube is removed participants are treated with the three oxygen therapy devices (Optiflow™, Boussignac™, and standard facemask with a reservoir bag) in a random order. Airway pressure and amount of oxygen inhaled are measured using a catheter (tube) inserted through the hole left by the tracheotomy tube. Comfort is also evaluated.

What are the possible benefits and risks of participating?
The results of this study could help determine which oxygen therapy is the most effective for a given patient. There are no risks involved in this study.

Where is the study run from?
Intensive care unit at the University of Montpellier Saint Eloi Hospital (France)

When is the study starting and how long is it expected to run for?
June 2009 to April 2011

Who is funding the study?
Fisher & Paykel Healthcare (France)

Who is the main contact?
Dr Gerald Chanques
g-chanques@chu-montpellier.fr

Trial website

Contact information

Type

Scientific

Primary contact

Dr Gerald Chanques

ORCID ID

Contact details

Departement d'Anesthésie-Réanimation (DAR)
Hôpital Saint Eloi
Centre Hospitalier Universitaire de Montpellier
80
avenue Augustin Fliche
Montpellier
34295
France
+33 (0)467 337 272
g-chanques@chu-montpellier.fr

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

V2 Apr 6th 2009

Study information

Scientific title

Comparison of three high flow oxygen therapy delivery devices: a clinical physiological cross-over study

Acronym

Study hypothesis

Our hypothesis was that three commonly used oxygen therapy devices (1-Optiflow™; 2-Boussignac™, and 3-standard facemask with a reservoir bag) could provide different inspired fractions of oxygen and airway pressure measured in the trachea, as well as respiratory comfort for the same oxygen flow.

To evaluate this hypothesis, a prospective physiological cross-over study was performed in ICU patients.

Ethics approval

1. Institutional Review Board of the Saint-Eloi Teaching Hospital (Comité de Protection des Personnes Sud Méditerranée IV, Montpellier, France)
2. National Agency for Health Safety regarding Healthcare Materials (Agence Française de Sécurité Sanitaire des Produits-de-Santé), ref: ID-RCB-2009-A00190-57

Study design

Cross-over physiological study

Primary study design

Interventional

Secondary study design

Randomised cross over trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

Respiratory failure requiring critical care

Intervention

1. Optiflow™
2. Boussignac™
3. Standard facemask with a reservoir bag

Airway-pressures and Fraction of inspired oxygen (FiO2) were measured by a tracheal catheter inserted through the hole of the tracheotomy tube after removal. Comfort was also evaluated by self-reporting.

Intervention type

Device

Phase

Not Applicable

Drug names

Primary outcome measures

Mean airway pressure measured in the trachea

Secondary outcome measures

1. FiO2
2. Noise intensity
3. Respiratory and auditory discomfort

Overall trial start date

25/06/2009

Overall trial end date

14/04/2011

Reason abandoned

Eligibility

Participant inclusion criteria

1. Consecutive patients ≥ 18 years old hospitalized in a medical-surgical ICU
2. Planned removal of a tracheotomy tube previously placed in the ICU for weaning from mechanical ventilation

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

n=10

Participant exclusion criteria

1. Pregnancy
2. Adult under tutelage
3. Contraindications for non-invasive ventilation, as defined by the last French consensus conference

Recruitment start date

25/06/2009

Recruitment end date

14/04/2011

Locations

Countries of recruitment

France

Trial participating centre

Saint Eloi Hospital (Hôpital Saint Eloi)
Montpellier
34295
France

Sponsor information

Organisation

Saint Eloi Hospital (Hôpital Saint Eloi) (France)

Sponsor details

c/o Samir Jaber
Association for Research and Education in Transplantation
Anesthesiology and Critical Care (ARFTAR)
DAR B
80
avenue Augustin Fliche
Montpellier
34295
France

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Industry

Funder name

Fisher & Paykel Healthcare (France)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23857440

Publication citations

Additional files

Editorial Notes

06/10/2016: Plain English summary added.