Non-Invasive Positive Pressure Ventilation and Adult Respiratory Distress Syndrome (ARDS) (NPPV)

Eskisehir Osmangazi University

Status: Completed

Conditions: Acute Respiratory Distress Syndrome

Treatments: Device: the application of NPPV; Device: invasive ventilation

Study type: Interventional

Funder types: Other

Identifiers

NCT00644930

ISRCTN73824458

Details and patient eligibility

About

Background and objective: To determine the efficacy of non-invasive positive pressure ventilation (NPPV) and its effects upon intubation rate and mortality in ARDS.

Full description

Methods: This study was performed in the respiratory intensive care unit (ICU) at a university hospital. 20 patients who achieved the diagnostic criteria for ARDS were included. The patients were prospectively allocated into two groups: a standard therapy group and a NPPV group. Invasive mechanical ventilation indications had been determined before the study. Invasive ventilation was applied to those who in need of intubation, while those given intubation received a standard medical treatment.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:The following criteria indicated immediate intubation was needed:

1. Apne or respiratory pauses with loss of consciousness or gasping for breath or imminent respiratory arrest.
2. Inability to increase the patient's PaO2 to more than 40 mmHg and SpO2 to more than 80% with a FiO2>0.6.
3. Inability to increase the patient's pH levels above 7.35, and development of blurred consciousness and confusion (Glasgow Coma Scale <9) due to respiratory acidosis despite all the support given.
4. Instability of the patient's hemodynamic parameters (such as systolic blood pressure <80 mmHg or heart rate <50 beats/minute lasting >1 hour despite fluid resuscitation).

Exclusion Criteria:Contraindications for NPPV include:

1. The need for urgent intubation.
2. The need for frequent aspiration due to excessive secretions (more frequent than 15 min.).
3. Inability of the patient to adapt himself / herself to the device or unwillingness to undergo NPPV.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

1

Experimental group

Description:

ARDS patients in the NPPV group showing no indications for urgent intubation received NPPV in addition to standard medical therapy, and those with indications were intubated.

Treatment:

Device: the application of NPPV

2

Active Comparator group

Description:

Patients in the standard therapy group without indications for urgent intubation were only given standard medical therapy (such as oxygen, antibiotics, and bronchodilators), and IMV through an endotracheal tube was applied when intubation criteria were met.

Treatment:

Device: invasive ventilation