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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00644930
Acronym
NPPV
Enrollment
20
Registered
2008-03-27
Start date
2003-08-31
Completion date
2007-12-31
Last updated
2008-03-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Respiratory Distress Syndrome

Keywords

ARDS,, noninvasive ventilation,, intubation,, mortality,, intensive care

Brief summary

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

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.

Interventions

DEVICEthe application of NPPV

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.

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.

Sponsors

Eskisehir Osmangazi University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Intubation rate48 hours

Secondary

MeasureTime frame
Hospital mortality

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026