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

NCT00644930 | Completed DMC

• 1 other identifier: ISRCTN73824458
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Respiratory Distress Syndrome

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Intubation rate

  48 hours

Secondary Outcomes (1)

• Hospital mortality

Study Arms (2)

1

EXPERIMENTAL

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

2

ACTIVE COMPARATOR

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

Interventions

the application of NPPV 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.

Also known as: NPPV group

1

invasive ventilation 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.

Also known as: Standard therapy group

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Eskisehir Osmangazi University: lead

Study Sites (1)

Eskisehir Osmangazi University, Medical Faculty,

Eskişehir, Merkez, 26040, Turkey (Türkiye)

Location

Related Publications (3)

• 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.

  PMID: 16696863 RESULT

• 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.

  PMID: 12907562 RESULT

• 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.

  PMID: 17133177 RESULT

MeSH Terms

Conditions

Respiratory Distress Syndrome

Interventions

Noninvasive Ventilation

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Intervention Hierarchy (Ancestors)

Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Officials

• Irfan Ucgun, Ass Prof Dr

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

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 14, 2008
• First Posted: March 27, 2008
• Study Start: August 1, 2003
• Primary Completion: September 1, 2005
• Study Completion: December 1, 2007
• Last Updated: March 27, 2008

Record last verified: 2008-03

Locations

TU (1)