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Completed

NCT Number: NCT00644930

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

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Eskisehir Osmangazi University, Medical Faculty,

Eskişehir, Merkez, 26040, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

the application of NPPV

Device

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.

Other names: NPPV group

invasive ventilation

Device

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.

Other names: Standard therapy group

Primary outcomes

  1. Intubation rate

    Time frame: 48 hours

Secondary outcomes

  1. Hospital mortality

Sponsors and collaborators

Lead sponsor

Eskisehir Osmangazi University

Other

Registry information

Official study title

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

Acronym: NPPV

Important dates

Study start
2003
Primary completion
2005
Study completion
2007
First posted
Mar 27, 2008
Registry last updated
Mar 27, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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