AVAPS in Acute Respiratory Failure of various etiologies
| ISRCTN | ISRCTN96455367 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN96455367 |
| Secondary identifying numbers | 2011.14 (1) |
- Submission date
- 06/07/2017
- Registration date
- 19/07/2017
- Last edited
- 05/09/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English Summary
Background and study aims
Acute respiratory failure occurs when the lungs are unable to remove the carbon dioxide from the lungs. This can be caused by a variety of lung issues such as chronic obstructive pulmonary disease (COPD) (causes the airways to be narrowed), asthma (difficulty breathing), pneumonia (swelling of the lungs), acute respiratory distress syndrome (ARDs) (when fluid buildings up in the lungs), congestive heart failure and interstitial lung disease (diseases affecting the tissue and space around the air sacs of the lungs). The usually treatment is to provide helping breathing. Noninvasive ventilation is a type of breathing support that involves the patient wearing a face mask during sleep which is connected to the machine that supplies a constant steam of pressurised air to help keep the airways open. The settings of the noninvasive ventilation are determined based on clinical evaluation, blood gas, volumes, flow and pressure. This is usually done individually and is different for patients. Having a fixed and preprogrammed setting that is kept constant could be helpful, such as using a BIPAP S/T AVAPS strategy. The aim of this study is to evaluate the results of using the ventilator strategy on patients with acute respiratory failure due to different reasons.
Who can participate?
Adults aged 18 and older with acute respiratory failure.
What does the study involve?
Participants are allocated based on their reason for acute respiratory failure. They are then given the BIPAP S/T AVAPS strategy. This is initially programmed to provide maximal inspiratory positive pressure of 20 cm and a minimum of 12 cm with a positive expiratory pressure of 6-8 cm. Participants are followed up to measure the blood gas levels, severity of diseases, blood pressure, heart rate, respiratory rate and other breathing measures.
What are the possible benefits and risks of participating?
Participants may benefit from using the non-invasive ventilation such as the use of additional medication (sedation) and a not having a tube in the mouth. There are risks of complications with the mask and airway pressures.
Where is the study run from?
Universidad de Guayaquil (Ecuador)
When is the study starting and how long is it expected to run for?
December 2011 to January 2014
Who is funding the study?
1. Universidad San Francisco de Quito (Ecuador)
2. Universidad San Francisco de Quito (Ecuador)
3. Santa Maria Clinic (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
The University of Guayaquil (Universidad de Guayaquil)
Facultad de Ciencias Médicas
Av. Kennedy y Av. Delta
Guayaquil
090514
Ecuador
 ORCID ID |
0000-0002-7778-0362 |
|---|
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 cohort study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | ISRCTN96455367_PIS_Spanish.pdf |
| Scientific title | Non-Invasive mechanical Ventilation with pressure support guaranteed with average volume (AVAPS) in Acute Respiratory Failure of various etiologies |
| Study acronym | NIV and AVAPS |
| Study hypothesis | The aim of this study is to evaluate if the ventilatory strategy is useful in patients with acute respiratory failure of various etiologies. |
| Ethics approval(s) | Teaching and Research Department of the Santa Maria Clinic, 01/12/2010, ref: 2010.14 (1) |
| Condition | The patients were divided according to the pathology on the basis of which presented the acute respiratory failure: COPD / bronchial asthma / pneumonia / ARDS / congestive heart failure and interstitial disease |
| Intervention | Participants are allocated to groups based on their type of acute respiratory failure: Hypercapnic ARF: Obstructive diseases (COPD and bronchial asthma) Hypoxemic ARF: Pneumonia, ARDS, congestive heart failure, and intestitial lung disease Participants are then given BiPaP S/T +AVAPS therapy. The ventilatory parameters are initially programmed in the BiPAP S/T mode with AVAPS with a maximal inspiratory positive pressure (IPAP) programmed in the 20 cm H2O device and a minimum programmed IPAP of 12 cm H2O with a positive expiratory pressure (EPAP) of 6-8 cm water. The programmed tidal volume is 6-8 ml/kg of ideal body weight, using the following formula 55.5 ± 2.3 (inches-60) for men and 45.5 for women + 2.3 (inches) 60) respiratory rate was 14-20 breaths/min, rise time 300-400 ms and inspiratory time was 0.8 - 1.2s. Oxygen supplements are added through an oxygen adapter close to the mask, to keep the SaO2 above 90%. Maximum IPAP, exhaled tidal volume (Vt exh), Vmin and leaks arecontrolled through the ventilator software. This is done using the BiPAP Synchrony with AVAPS and Autotrak (Respironics Inc., Murrysville, Pennsylvania, USA) and a series of Mirage IV (Resmed) face masks. Participants are followed up to measure the blood gas levels, severity of diseases, blood pressure, heart rate, respiratory rate and other breathing measures. |
| Intervention type | Device |
| Pharmaceutical study type(s) | Not Applicable |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | BiPAP S/T plus average volume-assured pressure support (AVAPS) |
| Primary outcome measure | 1. Use of NIV is measured using patient records at discharge from hospital 2. Aterial blood gas is measured using an arterial blood gas test (blood test) at baseline, one, 12 and 24 hours of NIV use 3. Severity of disease is measured using the APACHE II (Acute Physiology and Chronic Health Evaluation (APACHE II ) score at range (0-71 points) 4. Blood pressure (mm/Hg) is measured using a blood pressure cuff 5. Heart rate is measured using pulse monitors 6. Respiratory rate is measured using the amount of breaths over one minute. 7. Tidal volume (mL) programmed AVAPs is measured using patient records. 8. Levels of IPAP (cmH2O) are measured using patient records 9. Level of EPAP (cmH2O) are measured using patient records 10. Inspiratory time (mseg) is measured using patient records 11. Tidal volume patients (mL) is measured using patient records 12. Radiographic changes are measured at number quadrant divided into four according to the affection 13. Complications (excessive discomfort, nasal ulcer, gastric distension and claustrophobia) are measured using patient records |
| Secondary outcome measures | 1. Days of hospitalisation is measured using patient records at number of discharge 2. Number of endotrachael intubation is measured using patient records at number of intubated patients and their percentage at discharge 3. Death is measured using patient records at time of death |
| Overall study start date | 01/07/2010 |
| Overall study end date | 01/01/2014 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 68 |
| Total final enrolment | 68 |
| Participant inclusion criteria | 1. Aged 18 years and over 2. Admitted to the intensive care unit of Santa Maria Clinic 3. Acute respiratory failure due to exacerbation of COPD, asthma, pneumonia, ARDS, congestive heart failure and intestitial lung disease |
| Participant 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 5. Urgent intubation due to cardiorespiratory arrest and hemodynamic instability with systolic pressure less than 80 mm Hg. 6. Hemodynamic instability 7. Excess of respiratory secretions 8. Non-cooperative or agitated 9. Unable to use the interface device 10. Has had recent surgery of the upper airway, 11. Received NIV with “Do not resuscitate orders" |
| Recruitment start date | 01/12/2010 |
| Recruitment end date | 01/12/2010 |
Locations
Countries of recruitment
- Ecuador
Study participating centres
Guayaquil
5934
Ecuador
Valle de Cumbaya
Quito
5932
Ecuador
Lorenzo de Garaycoa 3209 y Argentina
Guayaquil
5934
Ecuador
Sponsor information
University/education
Ciudadela Universitaria
Facultad de Ciencias Médicas
Av. Kennedy y Av. Delta
Guayaquil
5934
Ecuador
| Website | https://servicioenlinea.ug.edu.ec/siug/ |
|---|
University/education
School of Medicine
Valle de los Chillos en Cumbaya
Diego de Robles y Vía Interoceánica
Quito
090514
Ecuador
| Website | http://www.usfq.edu.ec |
|---|
Not defined
-
Guayaquil
-
Ecuador
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 | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer reviewed journal |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from Killen Briones Claudett (kyllenbrio@yahoo.com). |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | 01/04/2019 | No | Yes | ||
| Results article | 30/12/2021 | 05/09/2023 | Yes | No |
Additional files
- ISRCTN96455367_PIS_Spanish.pdf
- Uploaded 01/04/2019
Editorial Notes
05/09/2023: Publication reference and the total final enrolment added.
01/04/2019: The participant information sheet has been uploaded
26/07/2017: Added new contact.
