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

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

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

Study Overview

• Status: Completed
• Conditions: Acute Respiratory Distress Syndrome
• Intervention / Treatment: 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 Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Merkez
    • Eskisehir, Merkez, Turkey, 26040
      • Eskisehir Osmangazi University, Medical Faculty,

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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 Names: Standard therapy group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Intubation rate	48 hours

Secondary Outcome Measures

Outcome Measure
Hospital mortality

Collaborators and Investigators

• Sponsor: Eskisehir Osmangazi University
• Investigators: Study Chair: Irfan Ucgun, Ass Prof Dr, Eskisehir Osmangazi University, Medical Faculty, Department of Chest Dis.

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: August 1, 2003
• Primary Completion (ACTUAL): September 1, 2005
• Study Completion (ACTUAL): December 1, 2007

Study Registration Dates

• First Submitted: March 14, 2008
• First Submitted That Met QC Criteria: March 26, 2008
• First Posted (ESTIMATE): March 27, 2008

Study Record Updates

• Last Update Posted (ESTIMATE): March 27, 2008
• Last Update Submitted That Met QC Criteria: March 26, 2008
• Last Verified: March 1, 2008

More Information

Terms related to this study

• Keywords: intensive care; ARDS,; intubation,; mortality,; noninvasive ventilation,
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Disease; Infant, Newborn, Diseases; Lung Injury; Infant, Premature, Diseases; Syndrome; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury
• Other Study ID Numbers: ISRCTN73824458