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

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

Detailed Description
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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.

Official Title
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The Efficacy of Non-Invasive Positive Pressure Ventilation in ARDS: A Controlled Cohort Study

Conditions
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Acute Respiratory Distress Syndrome

Intervention / Treatment
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* Device: the application of NPPV
* Device: invasive ventilation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria:The following criteria indicated immediate intubation was needed: Apne or respiratory pauses with loss of consciousness or gasping for breath or imminent respiratory arrest. Inability to increase the patient's PaO2 to more than 40 mmHg and SpO2 to more than 80% with a FiO2>0.6. 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. 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: The need for urgent intubation. The need for frequent aspiration due to excessive secretions (more frequent than 15 min.). Inability of the patient to adapt himself / herself to the device or unwillingness to undergo NPPV.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>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. | Device: the application of NPPV<br>* 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. BIPAP Vision machine (Respironics, PA, USA) were used for NPPV.<br>* Other names: NPPV group;|
| Active Comparator: 2<br>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. | Device: invasive ventilation<br>* Standard therapy group (invasive ventilation). Patients in need of endotracheal intubation were mechanically ventilated with Amadeus (Hamilton, Via Nova, Switzerland) and Esprit (Respironics, PA, USA) ventilators in the assist-control or synchronized intermittent mandatory ventilation (SIMV) mode.<br>* Other names: Standard therapy group;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intubation rate |  | 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospital mortality |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ARDS,, noninvasive ventilation,, intubation,, mortality,, intensive care