Use of non-invasive mechanical ventilation with pressure support guaranteed with average volume (AVAPS) in de novo hypoxemic respiratory failure

• Register: ISRCTN
• Last refreshed on: 15 July 2019
• Main ID: ISRCTN13036391
• Date of registration: 26/07/2017
• Prospective Registration: No
• Primary sponsor: Universidad de Guayaquil
• Public title: Use of non-invasive mechanical ventilation with pressure support guaranteed with average volume (AVAPS) in de novo hypoxemic respiratory failure
• Scientific title: AVAPS in de novo hypoxemic respiratory failure
• Date of first enrolment: 01/12/2010
• Target sample size: 70
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN13036391
• Study type: Observational
• Study design: Single-center retrospective/prospective non-randomized study (Treatment)
• Phase: Not Applicable

Countries of recruitment

Ecuador

Contacts

• Name: Killen Harold Briones Claudett

Key inclusion & exclusion criteria

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

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"


Age minimum:
Age maximum:
Gender: Both

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)
Respiratory

Intervention(s)

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.

Primary Outcome(s)

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(s)

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)

Secondary ID(s)

01/12/2010 serial: 2010.14 (2)

Source(s) of Monetary Support

Universidad San Francisco de Quito

Secondary Sponsor(s)

Universidad San Francisco de Quito

Ethics review

Status:
Approval date:
Contact:

Teaching and Research Department of the Santa Maria Clinic, 01/12/2010, ref: 2010.14 (2)

Results

• Results available: Yes
• Date Completed: 01/01/2014