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

This study has been completed.
Sponsor:
Information provided by:
Eskisehir Osmangazi University
ClinicalTrials.gov Identifier:
NCT00644930
First received: March 14, 2008
Last updated: March 26, 2008
Last verified: March 2008
  Purpose

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 Intervention
Acute Respiratory Distress Syndrome
Device: the application of NPPV
Device: invasive ventilation

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Efficacy of Non-Invasive Positive Pressure Ventilation in ARDS: A Controlled Cohort Study

Resource links provided by NLM:


Further study details as provided by Eskisehir Osmangazi University:

Primary Outcome Measures:
  • Intubation rate [ Time Frame: 48 hours ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Hospital mortality [ Designated as safety issue: Yes ]

Enrollment: 20
Study Start Date: August 2003
Study Completion Date: December 2007
Primary Completion Date: September 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00644930

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

Publications:
Responsible Party: Dr. Irfan Ucgun, Eskisehir Osmangazi University, Department of Chest Diseases
ClinicalTrials.gov Identifier: NCT00644930     History of Changes
Other Study ID Numbers: ISRCTN73824458, ISRCTN73824458
Study First Received: March 14, 2008
Last Updated: March 26, 2008
Health Authority: Turkey: Ethics Committee

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

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

ClinicalTrials.gov processed this record on August 28, 2014