search
Back to results

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

Primary Purpose

Acute Respiratory Distress Syndrome

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
the application of NPPV
invasive ventilation
Sponsored by
Eskisehir Osmangazi University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Respiratory Distress Syndrome focused on measuring ARDS,, noninvasive ventilation,, intubation,, mortality,, intensive care

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Eskisehir Osmangazi University, Medical Faculty,

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Intubation rate

Secondary Outcome Measures

Hospital mortality

Full Information

First Posted
March 14, 2008
Last Updated
March 26, 2008
Sponsor
Eskisehir Osmangazi University
search

1. Study Identification

Unique Protocol Identification Number
NCT00644930
Brief Title
Non-Invasive Positive Pressure Ventilation and Adult Respiratory Distress Syndrome (ARDS)
Acronym
NPPV
Official Title
The Efficacy of Non-Invasive Positive Pressure Ventilation in ARDS: A Controlled Cohort Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2008
Overall Recruitment Status
Completed
Study Start Date
August 2003 (undefined)
Primary Completion Date
September 2005 (Actual)
Study Completion Date
December 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Eskisehir Osmangazi University

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Respiratory Distress Syndrome
Keywords
ARDS,, noninvasive ventilation,, intubation,, mortality,, intensive care

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
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.
Arm Title
2
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
the application of NPPV
Other Intervention Name(s)
NPPV group
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
invasive ventilation
Other Intervention Name(s)
Standard therapy group
Intervention Description
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.
Primary Outcome Measure Information:
Title
Intubation rate
Time Frame
48 hours
Secondary Outcome Measure Information:
Title
Hospital mortality

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Irfan Ucgun, Ass Prof Dr
Organizational Affiliation
Eskisehir Osmangazi University, Medical Faculty, Department of Chest Dis.
Official's Role
Study Chair
Facility Information:
Facility Name
Eskisehir Osmangazi University, Medical Faculty,
City
Eskisehir
State/Province
Merkez
ZIP/Postal Code
26040
Country
Turkey

12. IPD Sharing Statement

Citations:
PubMed Identifier
16696863
Citation
Rana S, Jenad H, Gay PC, Buck CF, Hubmayr RD, Gajic O. Failure of non-invasive ventilation in patients with acute lung injury: observational cohort study. Crit Care. 2006;10(3):R79. doi: 10.1186/cc4923. Epub 2006 May 12.
Results Reference
result
PubMed Identifier
12907562
Citation
Liesching T, Kwok H, Hill NS. Acute applications of noninvasive positive pressure ventilation. Chest. 2003 Aug;124(2):699-713. doi: 10.1378/chest.124.2.699.
Results Reference
result
PubMed Identifier
17133177
Citation
Antonelli M, Conti G, Esquinas A, Montini L, Maggiore SM, Bello G, Rocco M, Maviglia R, Pennisi MA, Gonzalez-Diaz G, Meduri GU. A multiple-center survey on the use in clinical practice of noninvasive ventilation as a first-line intervention for acute respiratory distress syndrome. Crit Care Med. 2007 Jan;35(1):18-25. doi: 10.1097/01.CCM.0000251821.44259.F3.
Results Reference
result

Learn more about this trial

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

We'll reach out to this number within 24 hrs