Comparison of three high flow oxygen therapy delivery devices
| ISRCTN | ISRCTN15995925 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15995925 |
| Secondary identifying numbers | V2 Apr 6th 2009 |
- Submission date
- 17/08/2012
- Registration date
- 20/09/2012
- Last edited
- 06/10/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Respiratory
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
Contact information
Scientific
Departement d'Anesthésie-Réanimation (DAR)
Hôpital Saint Eloi
Centre Hospitalier Universitaire de Montpellier
80, avenue Augustin Fliche
Montpellier
34295
France
| Phone | +33 (0)467 337 272 |
|---|---|
| g-chanques@chu-montpellier.fr |
Study information
| Study design | Cross-over physiological study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised cross over trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | Comparison of three high flow oxygen therapy delivery devices: a clinical physiological cross-over study |
| 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(s) | 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 |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | |
| Primary outcome measure | Mean airway pressure measured in the trachea |
| Secondary outcome measures | 1. FiO2 2. Noise intensity 3. Respiratory and auditory discomfort |
| Overall study start date | 25/06/2009 |
| Overall study end date | 14/04/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | n=10 |
| 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 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
Study participating centre
34295
France
Sponsor information
Hospital/treatment centre
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
"ROR" |
https://ror.org/04pwyfk22 |
|---|
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/12/2013 | Yes | No |
Editorial Notes
06/10/2016: Plain English summary added.
