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

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ClinicalTrials.gov Identifier: NCT00644930
Recruitment Status : Completed
First Posted : March 27, 2008
Last Update Posted : March 27, 2008
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment
Acute Respiratory Distress Syndrome Device: the application of NPPV Device: invasive ventilation

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Efficacy of Non-Invasive Positive Pressure Ventilation in ARDS: A Controlled Cohort Study
Study Start Date : August 2003
Primary Completion Date : September 2005
Study Completion Date : December 2007

Arms and Interventions

Arm Intervention/treatment
Experimental: 1
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
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 Name: NPPV group
Active Comparator: 2
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
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 Name: Standard therapy group

Outcome Measures

Primary Outcome Measures :
  1. Intubation rate [ Time Frame: 48 hours ]

Secondary Outcome Measures :
  1. Hospital mortality

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts 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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00644930

Eskisehir Osmangazi University, Medical Faculty,
Eskisehir, Merkez, Turkey, 26040
Sponsors and Collaborators
Eskisehir Osmangazi University
Study Chair: Irfan Ucgun, Ass Prof Dr Eskisehir Osmangazi University, Medical Faculty, Department of Chest Dis.
More Information

Responsible Party: Dr. Irfan Ucgun, Eskisehir Osmangazi University, Department of Chest Diseases
ClinicalTrials.gov Identifier: NCT00644930     History of Changes
Other Study ID Numbers: ISRCTN73824458
First Posted: March 27, 2008    Key Record Dates
Last Update Posted: March 27, 2008
Last Verified: March 2008

Keywords provided by Eskisehir Osmangazi University:
noninvasive ventilation,
intensive care

Additional relevant MeSH terms:
Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Acute Lung Injury
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Lung Injury