Plain English Summary
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
Trial website
Contact information
Type
Scientific
Primary contact
Prof Killen Harold Briones Claudett
ORCID ID
http://orcid.org/0000-0002-7778-0362
Contact details
Ciudadela Victoria del Rio Mz 2963 Villa 17
Guayaquil
Postal code: 090514 Guayaquil – ECUADOR Area Code: 5934
Ecuador
+593 (0)989097152
kyllenbrio@yahoo.com
Type
Scientific
Additional contact
Dr Michelle Grunauer
ORCID ID
http://orcid.org/0000-0002-5821-7603
Contact details
Av. Interoceánica Km 12 ½ Edificio de Especialidades Médicas PB Hospital de los Valles
Universidad San Francisco de Quito
Quito
-
Ecuador
+593 (0)9 98938210
mgrunauer@usfq.edu.ec
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
01/12/2010 serial: 2010.14 (2)
Study information
Scientific title
AVAPS in de novo hypoxemic respiratory failure
Acronym
NIMV with AVAPS
Study hypothesis
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
Teaching and Research Department of the Santa Maria Clinic, 01/12/2010, ref: 2010.14 (2)
Study design
Single-center retrospective/prospective non-randomized study
Primary study design
Observational
Secondary study design
Longitudinal study
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
See additional files
Condition
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
Phase
Not Applicable
Drug names
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 trial start date
01/01/2010
Overall trial end date
01/01/2014
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
70
Total final enrolment
38
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
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"
Recruitment start date
01/12/2010
Recruitment end date
01/01/2014
Locations
Countries of recruitment
Ecuador
Trial participating centre
Intensive Care Unit of the Santa Maria Clinic
Lorenzo de Garaicoa y Capitan Najera
Guayaquil
5934
Ecuador
Trial participating centre
Universidad de Guayaquil
Facultad de Ciencias Medicas
Av. Kennedy y Av. Delta
Guayaquil
Postal code: 090514 Guayaquil – ECUADOR Area Code: 5934
Ecuador
Trial participating centre
Universidad San Francisco de Quito
Facultad de Ciencias de la Salud
Diego de Robles y Vía Interoceánica
Quito
Postal code: 090514 Guayaquil – Ecuador
Ecuador
Sponsor information
Organisation
Universidad de Guayaquil
Sponsor details
Facultad de Ciencias Medicas
Av. Kennedy y Av. Delta. Ciudadela Universitaria
Guayaquil
090514
Ecuador
(+5934) 04-229-3552
jorge.dahern@ug.edu.ec
Sponsor type
University/education
Website
Organisation
Universidad San Francisco de Quito
Sponsor details
Escuela de Medicina
Diego de Robles y Vía Interoceánica
Quito
090514
Ecuador
(+593 2) 297-1700, ext.1795
mgrunauer@usfq.edu.ec
Sponsor type
University/education
Website
Organisation
Universidad Tecnológica Empresarial de Guayaquil
Sponsor details
Sponsor type
Not defined
Website
Funders
Funder type
University/education
Funder name
Universidad San Francisco de Quito
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Planned publication in a high-impact peer-reviewed journal
IPD sharing statement
The datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication.
Intention to publish date
01/12/2017
Participant level data
Other
Basic results (scientific)
Publication list
2018 results in: https://www.ncbi.nlm.nih.gov/pubmed/30317536 (added 20/06/2019)
Publication citations
Additional files
- ISRCTN13036391_PIS_24Jul17_Spanish.pdf Uploaded 27/07/2017