Randomised controlled trial of average volume-assured pressure support (AVAPS) versus spontaneous/times (ST) mode pressure support ventilation in obesity hypoventilation syndrome
| ISRCTN | ISRCTN63940700 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN63940700 |
| Secondary identifying numbers | EAME2007AVAPS001 |
- Submission date
- 15/09/2008
- Registration date
- 11/12/2008
- Last edited
- 30/11/2012
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Respiratory
Plain English summary of protocol
Background and study aims?
There is an increase worldwide in obesity and obesity related respiratory problems. In patients with severe obesity, significant breathing problems can develop which may prevent them from breathing properly during sleep. This can cause a build-up of waste gas in the blood and is called respiratory failure. Although this problem is increasingly common the best way to treat it remains unclear. The study was designed to evaluate a new medical device aimed at better controlling patients breathing during sleep in order to improve their breathing.
Who can participate?
Patients can participate in the study if they suffer with both severe obesity and respiratory failure without other underlying breathing or muscle problems.
What does the study involve?
The study involves being randomly picked to receive either standard treatment or the new device for a 3 month period. Patients will be unaware of which device they are given and will perform a number of tests to assess breathing and sleep as well as complete questionnaires to inform us as to how their condition affects their everyday lives.
What are the possible benefits and risks of participating?
It is not thought that there are any specific risks associated with the new device but taking part in the trial will involve additional trips to hospital. It is hoped that the new device may offer some improvements in symptom control and tolerability for patients.
Where is the study run from?
The lead study site is the Lane Fox Unit, St Thomas Hospital part of the Kings Academic Health Science Centre.
When is the study starting and how long is it expected to run for?
The study started in 2008 and was completed in 2010.
Who is funding the study?
Philips-Respironics
Who is the main contact?
Dr Patrick Murphy
patrickmurphy1@nhs.net
Contact information
Scientific
Lane Fox Respiratory Unit
St Thomas' Hospital
Department of Critical Care
Guy's and St Thomas' NHS Foundation Trust
Lambeth Palace Road
London
SE1 7EH
United Kingdom
| nicholas.hart@gstt.nhs.uk |
Study information
| Study design | Randomised parallel-group controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | |
| Study acronym | AVAPS-OHS |
| Study objectives | Average volume-assured pressure support (AVAPS) mode will deliver nocturnal ventilatory support more effectively than the spontaneous/times (S/T) mode and have greater physiological and clinical benefits in a subgroup of obesity hypoventilation syndrome (OHS) patients with severe obesity and marked daytime hypercapnia. |
| Ethics approval(s) | Guys Research Ethics Committee, South London REC Office 3 gave approval on the 21st January 2008 (ref: 07/H0804/140) |
| Health condition(s) or problem(s) studied | Obesity hypoventilation syndrome |
| Intervention | Bi-level positive airway pressure (BiPAP) ventilator will provide both the S/T and AVAPS modes. Total duration of intervention/follow-up: 3 months |
| Intervention type | Other |
| Primary outcome measure | Effectiveness of the nocturnal ventilatory support, assessed using the PaCO2 - daytime arterial blood gas (ABG) at baseline and 3 months |
| Secondary outcome measures | Physiological and clinical benefits in a subgroup of OHS patients with severe obesity and marked daytime hypercapnia, assessed by the following at baseline and 3 months: 1. Partial pressure of oxygen in arterial blood (PaO2), pH, bicarbonate areterial blood gas (HCO3-ABG) 2. Health related quality of life: Severe Respiratory insufficiency Questionnaire, Fatigue Severity Questionnaire 3. Anthropometric data: weight, BMI, neck, hip and waist circumference 4. Activity: Actiwatch® 5. Daytime vigilance: Epworth Sleepiness Scale, Oxford Sleep Resistance (OSLER) test |
| Overall study start date | 01/09/2008 |
| Completion date | 01/09/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 40 |
| Key inclusion criteria | 1. Both males and females, aged 18 - 90 years 2. Body mass index (BMI) greater than 40 kg/m^2 3. Daytime partial pressure of carbon dioxide in the arterial blood (PaCO2) greater than 6.5 kPa |
| Key exclusion criteria | Forced expiratory volume in one second (FEV1)/forced vital capacity (FVC) less than 70% |
| Date of first enrolment | 01/09/2008 |
| Date of final enrolment | 01/09/2009 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
SE1 7EH
United Kingdom
Sponsor information
Industry
20 Rue-Jacques Daguerre
Rueil-Malmaison
Paris
92500
France
| steven.coughlin@respironics.com | |
| Website | http://www.respironics.com |
"ROR" |
https://ror.org/05jz46060 |
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 | 01/08/2012 | Yes | No |
