Use of non-invasive mechanical ventilation with pressure support guaranteed with average volume (AVAPS) in de novo hypoxemic respiratory failure
| ISRCTN | ISRCTN13036391 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13036391 |
| Secondary identifying numbers | 01/12/2010 serial: 2010.14 (2) |
- Submission date
- 16/07/2017
- Registration date
- 26/07/2017
- Last edited
- 20/06/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Respiratory
Plain English summary of protocol
Background and study aims
Hypoxemic respiratory failure is a condition where there is not enough oxygen in the blood but levels of carbon dioxide are close to normal. Non-invasive ventilation is a form of treatment for acute respiratory failure in which a mask is placed covering the face and mouth of the patient to deliver oxygen. The aim of this study is to test a new noninvasive ventilation strategy in order to find out whether this technique is well tolerated by patients.
Who can participate?
Patients aged 18 and over with hypoxemic respiratory failure
What does the study involve?
All participants are treated with noninvasive ventilation using the new strategy and are evaluated during their stay in ICU and follow-up until discharge from hospital.
What are the possible benefits and risks of participating?
The new technique may avoid the need for endotracheal intubation (breathing tube) with a shorter hospital stay and fewer complications. The risks are related to the facial complications that could arise from the use of the mask (lacerations on the face and nose) and gastric distension (bloating of the stomach) due to the effects of the airway pressure.
Where is the study run from?
1. Santa Maria Clinic (Ecuador)
2. Universidad de Guayaquil (Ecuador)
3. Universidad San Francisco de Quito (Ecuador)
When is the study starting and how long is it expected to run for?
January 2010 to January 2014
Who is funding the study?
Universidad San Francisco de Quito (Ecuador)
Who is the main contact?
1. Dr Killen Briones Claudett
killen.brionesc@ug.edu.ec
2. Dr Michelle Grunauer
mgrunauer@usfq.edu.ec
Contact information
Scientific
Ciudadela Victoria del Rio Mz 2963 Villa 17
Guayaquil
Postal code: 090514 Guayaquil – ECUADOR Area Code: 5934
Ecuador
 ORCID ID |
0000-0002-7778-0362 |
|---|---|
| Phone | +593 (0)989097152 |
| kyllenbrio@yahoo.com |
Scientific
Av. Interoceánica Km 12 ½ Edificio de Especialidades Médicas PB Hospital de los Valles
Universidad San Francisco de Quito
Quito
-
Ecuador
| ORCID ID |
0000-0002-5821-7603 |
|---|---|
| Phone | +593 (0)9 98938210 |
| mgrunauer@usfq.edu.ec |
Study information
| Study design | Single-center retrospective/prospective non-randomized study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Longitudinal study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | ISRCTN13036391_PIS_24Jul17_Spanish.pdf |
| Scientific title | AVAPS in de novo hypoxemic respiratory failure |
| Study acronym | NIMV with AVAPS |
| Study objectives | The strategy of ventilation with BiPAP S/T - AVAPS - pressure (support guaranteed with average volume) is feasible in patients with de novo hypoxemic respiratory failure. |
| Ethics approval(s) | Teaching and Research Department of the Santa Maria Clinic, 01/12/2010, ref: 2010.14 (2) |
| Health condition(s) or problem(s) studied | De novo hypoxemic respiratory failure (not produced by acute exacerbations of COPD, chronic pulmonary diseases or congestive heart failure) |
| Intervention | The study consists of subjecting patients to noninvasive ventilation using a new strategy that includes the programming of ventilatory parameters in BiPAP S / T AVAPS mode in order to observe if this technique is well tolerated by the patients. All patients were admitted during the period between 01/12/2010 and 01/01/2014, informed consent was obtained from patients and their surrogates if they were not able to respond by themselves. A total of 70 patients were recruited for this study. All patients were evaluated during their stay in ICU and follow-up until discharge from hospital. |
| Intervention type | Device |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | |
| Primary outcome measure | Success or failure of the use of the NIV (expressed as percentage), evaluated during stay in ICU and follow-up until discharge from hospital |
| Secondary outcome measures | Evaluated during stay in ICU and follow-up until discharge from hospital: 1. Days of hospitalization (expressed in days) 2. Proportion requiring endotracheal intubation (expressed as percentage) 3. Death (expressed as percentage of patients) |
| Overall study start date | 01/01/2010 |
| Completion date | 01/01/2014 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 70 |
| Total final enrolment | 38 |
| Key inclusion criteria | 1. Aged 18 years and over 2. Patients who presented with signs of acute respiratory failure at the emergency room (RR >25 breath for minute, use of accessory muscles) for de novo hypoxemic respiratory failure (not produced by acute exacerbations of COPD, chronic pulmonary disease or congestive heart failure) with PaO2/FIO2 of mild to moderate as per thresholds defined in the Berlin criteria for the ARDS |
| Key exclusion criteria | 1. Facial deformity 2. Obstruction of the upper airway by surgery or trauma 3. Alterations in the central nervous system does not relating to hypercapnic encephalopathy 4. Cardiogenic pulmonary edema, pulmonary embolism, pneumothorax, hemoptysis, or septic shock 4. Urgent intubation due to cardiorespiratory arrest and hemodynamic instability with systolic pressure less than 80 mmHg 5. Hemodynamic instability 6. Excess of respiratory secretions 7. Non-cooperative or agitated 8. Unable to use the interface device 9. Recent surgery of the upper airway 10. Received NIV with “DO NOT RESUSCITATE ORDERS" |
| Date of first enrolment | 01/12/2010 |
| Date of final enrolment | 01/01/2014 |
Locations
Countries of recruitment
- Ecuador
Study participating centres
Guayaquil
5934
Ecuador
Av. Kennedy y Av. Delta
Guayaquil
Postal code: 090514 Guayaquil – ECUADOR Area Code: 5934
Ecuador
Diego de Robles y Vía Interoceánica
Quito
Postal code: 090514 Guayaquil – Ecuador
Ecuador
Sponsor information
University/education
Facultad de Ciencias Medicas
Av. Kennedy y Av. Delta. Ciudadela Universitaria
Guayaquil
090514
Ecuador
| Phone | (+5934) 04-229-3552 |
|---|---|
| jorge.dahern@ug.edu.ec |
University/education
Escuela de Medicina
Diego de Robles y Vía Interoceánica
Quito
090514
Ecuador
| Phone | (+593 2) 297-1700, ext.1795 |
|---|---|
| mgrunauer@usfq.edu.ec |
Not defined
Funders
Funder type
University/education
No information available
Results and Publications
| Intention to publish date | 01/12/2017 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Other |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | 24/07/2017 | 27/07/2017 | No | Yes | |
| Results article | results | 01/10/2018 | 20/06/2019 | Yes | No |
Additional files
- ISRCTN13036391_PIS_24Jul17_Spanish.pdf
- Uploaded 27/07/2017
Editorial Notes
20/06/2019: Publication reference and total final enrolment number added.
27/07/2017: Participant information sheet uploaded.
