Condition category
Respiratory
Date applied
16/07/2017
Date assigned
26/07/2017
Last edited
27/07/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

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

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

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

Publication citations

Additional files

Editorial Notes

27/07/2017: Participant information sheet uploaded.