Non-invasive mechanical ventilation with average volume assured pressure support (AVAPS) in hypercapnic encephalopathy
| ISRCTN | ISRCTN05135218 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN05135218 |
| Secondary identifying numbers | 1857461069795800 |
- Submission date
- 07/09/2012
- Registration date
- 18/09/2012
- Last edited
- 04/05/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Respiratory
Plain English Summary
Background and study aims
Patients with chronic obstructive pulmonary disease (COPD) have a number of lung conditions that make it difficult to breathe. NIMV (non-invasive mechanical ventilation) is a method of non-invasive ventilatory (breathing) support which deliver air through a face mask in order to keep the airways open. This is used to help patients with acute respiratory failure. One of the main problems with NIMV is that it can alter the consciousness of its users. A Bilevel positive airway pressure machine (BiPAP) such as another non-invasive form of therapy that provides continuous airway pressure to help patients breath. Bilevel positive airway pressure-spontaneous/timed (BiPAP S/T) with average volume assured pressure support (AVAPS) allows for setting a fixed tidal volume, and the system output automatically adjusts based on variations in inspiratory pressure to ensure the target value. Its long-term benefits have been demonstrated in patients with chronic respiratory failure, and other breathing issues such as obstructive sleep apnea, and alveolar hypoventilation syndrome. It could be helpful for COPD patients. The aim of this study is to determine if using a BiPAP S/T with AVAPS as the first line of noninvasive ventilatory treatment in patients with exacerbations of COPD and hypercapnic encephalopathy, is useful and safe.
Who can participate?
Adults over the age of 40 who are diagnosed with COPD or Hypercapnic encephalopathy.
What does the study involve?
Participants are randomly allocated to receiving either BiPap S/T with AVAPs or to being in the control group. Participants are followed up for their level of consciousness, how long they required the use of the ventilation, their hospital stays and their progression.
What are the possible benefits and risks of participating?
Not provided at time of registration.
Where is the study run from?
Geraneos (Ecuador)
When is the study starting and how long is it expected to run for?
February 2009 to September 2011
Who is funding the study?
Universidad San Francisco de Quito (Ecuador)
Who is the main contact?
Dr Killen Briones Claudett
kyllenbrio@yahoo.com
Contact information
Scientific
Geraneos II Mz 3010 Villa 7
Guayaquil
5934
Ecuador
| Phone | +593 4 289 3242 |
|---|---|
| kyllenbrio@yahoo.com |
Study information
| Study design | Prospective interventional match-controlled study |
|---|---|
| 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 | Non-invasive mechanical ventilation with average volume assured pressure support (AVAPS) in patients with chronic obstructive pulmonary disease and hypercapnic encephalopathy: prospective interventional match-controlled study |
| Study hypothesis | To determine if the use of BiPAP S/T with AVAPS as the first line of noninvasive ventilatory treatment in patients with exacerbations of Chronic obstructive pulmonary disease (COPD) and hypercapnic encephalopathy (GCS < 10), is useful and safe. |
| Ethics approval(s) | School of Medicine Ethics Committee of the Universidad San Francisco de Quito, 03 January 2009, ref: 3012009 |
| Condition | Infectious exacerbations of COPD and hypercapnic encephalopathy |
| Intervention | 11 patients with infectious exacerbations of COPD and hypercapnic encephalopathy with GCS < 10 were designated to receive BiPAP S/T with AVAPS. The control group was then selected from patients in the emergency unit with infectious exacerbations of COPD and encephalopathy (GCS < 10). |
| Intervention type | Other |
| Primary outcome measure | Level of consciousness (Glasgow Coma Scale score) |
| Secondary outcome measures | 1. Duration of mechanical ventilation 2. Hospital stay, and 3. Progression (exhaled tidal volume, inspiratory pressure, and arterial blood gases) |
| Overall study start date | 01/02/2009 |
| Overall study end date | 01/09/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 11 x 2 |
| Participant inclusion criteria | 1. Age > 40 years 2. COPD was diagnosed on the basis of the recommendations of the American Thoracic Society 3. Hypercapnic encephalopathy with GCS < 10 were designated to receive BiPAP S/T with AVAPS 4. The control group was then selected from patients in the emergency unit with infectious exacerbations of COPD and encephalopathy (GCS < 10). Patients were treated immediately and referred to us by doctors who were unaware of the study. Each patient was treated with NIV and was selected according to: Acute Physiology and Chronic Health Evaluation II (APACHE II) score within 4 points, age within 10 points, pH within 0.04, GCS within 2 points, and BMI within 2 points 5. Informed consent |
| Participant exclusion criteria | 1. A face deformity 2. Obstruction of the upper respiratory tract owing to recent surgery or trauma 3. Alterations in the central nervous system not related to a hypercapnic encephalopathy 4. Cardiogenic pulmonary edema, pneumothorax, pulmonary thromboembolism, hemoptysis, or septic shock 5. Urgent intubation owing to cardiac and/or respiratory arrest, and hemodynamic instability with a systolic arterial blood pressure (BP) of less than 80mmH 6. Other neurological illness |
| Recruitment start date | 01/02/2009 |
| Recruitment end date | 01/09/2011 |
Locations
Countries of recruitment
- Ecuador
Study participating centre
5934
Ecuador
Sponsor information
University/education
c/o Dr Killen Harold Briones Claudett
School of Medicine
Guayaquil
5934
Ecuador
| kyllenbrio@yahoo.com | |
"ROR" |
https://ror.org/01r2c3v86 |
Funders
Funder type
University/education
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 | 12/03/2013 | Yes | No |
Editorial Notes
04/05/2017: Plain English summary added.
