Clinical trial NCT00644930: Non-Invasive Positive Pressure Ventilation and Adult Respiratory Distress Syndrome (ARDS)
Official title: The Efficacy of Non-Invasive Positive Pressure Ventilation in ARDS: A Controlled Cohort Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Respiratory Distress Syndrome
Keywords: ARDS,
noninvasive ventilation,
intubation,
mortality,
intensive care
Lead sponsor: Eskisehir Osmangazi University
Sponsor class: OTHER
First posted: 2008-03-27
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Intubation rate
timeFrame: 48 hours
Secondary outcomes:
measure: Hospital mortality
Other outcomes:
Locations:
city: Eskisehir
country: Turkey
facility: Eskisehir Osmangazi University, Medical Faculty,
state: Merkez
Study officials:
affiliation: Eskisehir Osmangazi University, Medical Faculty, Department of Chest Dis.
name: Irfan Ucgun, Ass Prof Dr
role: STUDY_CHAIR
References:
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.
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.
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.