AVAPS in Acute Respiratory Failure of various etiologies

• Register: ISRCTN
• Last refreshed on: 18 September 2023
• Main ID: ISRCTN96455367
• Date of registration: 19/07/2017
• Prospective Registration: No
• Primary sponsor: The University of Guayaquil (Universidad de Guayaquil)
• Public title: AVAPS in Acute Respiratory Failure of various etiologies
• Scientific title: Non-Invasive mechanical Ventilation with pressure support guaranteed with average volume (AVAPS) in Acute Respiratory Failure of various etiologies
• Date of first enrolment: 01/12/2010
• Target sample size: 68
• Recruitment status: Completed
• URL: https://www.isrctn.com/ISRCTN96455367
• Study type: Observational
• Study design: Single-center retrospective cohort 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. 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
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"

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

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
Circulatory System
Acute respiratory failure

Intervention(s)

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.

Primary Outcome(s)

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(s)

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

Secondary ID(s)

2011.14 (1)

Source(s) of Monetary Support

Universidad San Francisco de Quito

Secondary Sponsor(s)

Universidad San Francisco de Quito

University of Guayaquil

Ethics review

Status:
Approval date:
Contact:

Old ethics approval format; Teaching and Research Department of the Santa Maria Clinic, 01/12/2010, ref: 2010.14 (1)

Results

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