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

NCT ID: NCT00644930

Last Updated: 2008-03-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-08-31
• Study Completion Date: 2007-12-31

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.

Conditions

Acute Respiratory Distress Syndrome

Keywords

ARDS,; noninvasive ventilation,; intubation,; mortality,; intensive care

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

the application of NPPV

Intervention Type: 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.

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.

Group Type: ACTIVE_COMPARATOR

invasive ventilation

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

Other Intervention Names

NPPV group; Standard therapy group

Eligibility Criteria

Inclusion Criteria

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

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eskisehir Osmangazi University

OTHER

Sponsor Role: lead

Responsible Party

Eskisehir Osmangazi University, Department of Chest Diseases

Principal Investigators

Irfan Ucgun, Ass Prof Dr

Role: STUDY_CHAIR

Eskisehir Osmangazi University, Medical Faculty, Department of Chest Dis.

Locations

Eskisehir Osmangazi University, Medical Faculty,

Eskişehir, Merkez, Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

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.

Reference Type: RESULT

PMID: 16696863 (View on PubMed)

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.

Reference Type: RESULT

PMID: 12907562 (View on PubMed)

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.

Reference Type: RESULT

PMID: 17133177 (View on PubMed)

Other Identifiers

ISRCTN73824458

Identifier Type: -

Identifier Source: secondary_id

ISRCTN73824458

Identifier Type: -

Identifier Source: org_study_id