OUT-OF-HOSPITAL CPAP STUDY

NCT00439075 | Completed Phase 4

• 1 other identifier: 0508703
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 1

Brief Summary

Evaluate efficacy and safety of CPAP in a randomised standard treatment controlled study, in out-of-hospital patients with acute cardiogenic pulmonary edema.

Conditions

Acute Cardiogenic Pulmonary Edema

Keywords

pulmonary disease; CPO; CPAP; oxygenation; out-of-hospital intervention

Outcome Measures

Primary Outcomes (1)

• Treatment success after the one hour study period, defined as all of respiratory rate less than 25 bpm, oxygen saturation greater than 90 %.

  One hour

Secondary Outcomes (2)

• Physiological parameters: vital signs, dyspnea , intubation rate

  one hour

• Safety parameters: adverse events , duration of hospitalisation , mortality 5 days and 30 days after the end of the one hour study period.

  during hospitalisation

Study Arms (2)

CPAP

EXPERIMENTAL

positive airway pressure

Procedure: CPAP

standard medical therapy

ACTIVE COMPARATOR

conventional oxygen therapy

Drug: standard treatment

Interventions

CPAP PROCEDURE

CPAP

standard treatment DRUG

standard medical therapy

Eligibility Criteria

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

You may qualify if:

• patient with supposed acute cardiogenic pulmonary edema, defined as acute dyspnea associated with a past of cardiomyopathy ischemia and physical signs consistent with pulmonary edema.
• patient giving written informed consent

You may not qualify if:

• Glasgow score \< 10
• Acute myocardial infarction ; ventricular arrhythmia ; pneumothorax ; evidence of pneumonia ; immediate need for intubation ; heart failure or respiratory stop witch requires a reanimation ; cardiogenic shock (systolic blood pressure \< 90 mmhg)
• Any neurological impairment that would prevent the protocol compliance
• participation in another study throughout this one
• women pregnant or nursing
• vomiting
• patient with an history of gastric surgery (\< 8days)

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (1)

SAMU - University Hospital Toulouse

Toulouse, 31059, France

Location

Related Publications (9)

• Crane SD, Elliott MW, Gilligan P, Richards K, Gray AJ. Randomised controlled comparison of continuous positive airways pressure, bilevel non-invasive ventilation, and standard treatment in emergency department patients with acute cardiogenic pulmonary oedema. Emerg Med J. 2004 Mar;21(2):155-61. doi: 10.1136/emj.2003.005413.

  PMID: 14988338 BACKGROUND

• Bellone A, Monari A, Cortellaro F, Vettorello M, Arlati S, Coen D. Myocardial infarction rate in acute pulmonary edema: noninvasive pressure support ventilation versus continuous positive airway pressure. Crit Care Med. 2004 Sep;32(9):1860-5. doi: 10.1097/01.ccm.0000139694.47326.b6.

  PMID: 15343013 BACKGROUND

• Mehta S, Jay GD, Woolard RH, Hipona RA, Connolly EM, Cimini DM, Drinkwine JH, Hill NS. Randomized, prospective trial of bilevel versus continuous positive airway pressure in acute pulmonary edema. Crit Care Med. 1997 Apr;25(4):620-8. doi: 10.1097/00003246-199704000-00011.

  PMID: 9142026 BACKGROUND

• L'Her E, Duquesne F, Paris A, Mouline J, Renault A, Garo B, Boles JM. [Spontaneous positive end-expiratory pressure ventilation in elderly patients with cardiogenic pulmonary edema. Assessment in an emergency admissions unit]. Presse Med. 1998 Jun 20;27(22):1089-94. French.

  PMID: 9767807 BACKGROUND

• Evans TW. International Consensus Conferences in Intensive Care Medicine: non-invasive positive pressure ventilation in acute respiratory failure. Organised jointly by the American Thoracic Society, the European Respiratory Society, the European Society of Intensive Care Medicine, and the Societe de Reanimation de Langue Francaise, and approved by the ATS Board of Directors, December 2000. Intensive Care Med. 2001 Jan;27(1):166-78. doi: 10.1007/s001340000721. No abstract available.

  PMID: 11280630 BACKGROUND

• Pang D, Keenan SP, Cook DJ, Sibbald WJ. The effect of positive pressure airway support on mortality and the need for intubation in cardiogenic pulmonary edema: a systematic review. Chest. 1998 Oct;114(4):1185-92. doi: 10.1378/chest.114.4.1185.

  PMID: 9792593 BACKGROUND

• Lenique F, Habis M, Lofaso F, Dubois-Rande JL, Harf A, Brochard L. Ventilatory and hemodynamic effects of continuous positive airway pressure in left heart failure. Am J Respir Crit Care Med. 1997 Feb;155(2):500-5. doi: 10.1164/ajrccm.155.2.9032185.

  PMID: 9032185 BACKGROUND

• The treatment of heart failure. Task Force of the Working Group on Heart Failure of the European Society of Cardiology. Eur Heart J. 1997 May;18(5):736-53. doi: 10.1093/oxfordjournals.eurheartj.a015339. No abstract available.

  PMID: 9152644 BACKGROUND

• Frontin P, Bounes V, Houze-Cerfon CH, Charpentier S, Houze-Cerfon V, Ducasse JL. Continuous positive airway pressure for cardiogenic pulmonary edema: a randomized study. Am J Emerg Med. 2011 Sep;29(7):775-81. doi: 10.1016/j.ajem.2010.03.007. Epub 2010 May 1.

  PMID: 20825901 RESULT

MeSH Terms

Conditions

Lung Diseases

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Study Officials

• DUCASSE Jean-Louis

  University Hospital, Toulouse

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 22, 2007
• First Posted: February 23, 2007
• Study Start: October 1, 2006
• Primary Completion: April 1, 2008
• Study Completion: April 1, 2008
• Last Updated: May 12, 2017

Record last verified: 2017-05

Locations

FR (1)