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Continuous Positive Airway Pressure for Acute Pulmonary Edema (CPAP)

Primary Purpose

Pulmonary Edema, Dyspnea, Paroxysmal

Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Continuous Positive Airway Pressure (CPAP)
usual care of acute pulmonary oedema
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulmonary Edema focused on measuring continuous positive airway pressure, outcome measure, clinical trial

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • age > 18
  • acute respiratory insufficiency with hypoxia in air
  • KILLIP score from 2 to 4
  • absence of known ST elevation acute coronary syndrome
  • accepted inform consent.

Exclusion Criteria:

  • age < 18
  • immediate intubation criteria (bradypnea, coma status)
  • refractory shock

Sites / Locations

  • DUCROS Laurent

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

A

B

Arm Description

Usual care of pulmonary acute oedema

CPAP + usual care of pulmonary acute oedema

Outcomes

Primary Outcome Measures

Composite criteria includes during the first 48 hours : death, tracheal intubation and mechanical ventilation rates, persistence of inclusion criteria for respiratory distress and shock until H2, reappearance of inclusion criteria after H2.

Secondary Outcome Measures

brain natriuretic factor value curves from H0, H6 and H24; composite criteria without intubation rate; clinical and biological parameters evolution during the first 48 hours, myocardial infarction rate, CPAP non tol

Full Information

First Posted
November 6, 2007
Last Updated
March 29, 2010
Sponsor
Assistance Publique - Hôpitaux de Paris
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1. Study Identification

Unique Protocol Identification Number
NCT00554580
Brief Title
Continuous Positive Airway Pressure for Acute Pulmonary Edema
Acronym
CPAP
Official Title
Effect of Continuous Positive Airway Pressure on Short Term Inhospital Prognosis for Acute Pulmonary Edema
Study Type
Interventional

2. Study Status

Record Verification Date
March 2010
Overall Recruitment Status
Completed
Study Start Date
October 2004 (undefined)
Primary Completion Date
July 2008 (Actual)
Study Completion Date
July 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Assistance Publique - Hôpitaux de Paris

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The investigators hypothesise that CPAP + pharmaceutical treatment, compared to pharmaceutical treatment alone, improves the respiratory and hemodynamic status of the patients before H2 after the inclusion time and decreases the rate of death and tracheal intubation during the first 48 hours.
Detailed Description
Patients are included at home after informed consent by the emergency medical team and transported during the following 2 hours to a cardiac intensive care unit were the treatment is purchased as well. Randomization process has been done previously with envelopes ; group A : pharmaceutical treatment alone , B pharmaceutical plus CPAP. Medical treatment includes furosemide and nitroglycerin (continuous perfusion and bolus), inotropes if needed, and all other specific treatment required (ex : anti antiarrhythmic drugs). Doses are free, adapted to the clinical response for respiratory and hemodynamic distress. CPAP is a passive high flow venturi system device alimented by a hyperbaric oxygen. FiO2 can be controlled and adapted to the pulsed oxygen saturation. PEP must be initially celled at least at 7.5 cmH2O and increased to 10 if well tolerated.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Edema, Dyspnea, Paroxysmal, Congestive Heart Failure
Keywords
continuous positive airway pressure, outcome measure, clinical trial

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
208 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Active Comparator
Arm Description
Usual care of pulmonary acute oedema
Arm Title
B
Arm Type
Experimental
Arm Description
CPAP + usual care of pulmonary acute oedema
Intervention Type
Procedure
Intervention Name(s)
Continuous Positive Airway Pressure (CPAP)
Intervention Description
Usual treatment of acute pulmonary oedema (see arm A) + CPAP will be administered without interruption for at least one hour and will be stopped for efficacy: stade I or II KILLIP classification and FR less or equal to 25 /min and SpO2 larger than 90 % ambient air and patient willing the stop of CPAP because of improvement of his clinical status.
Intervention Type
Procedure
Intervention Name(s)
usual care of acute pulmonary oedema
Intervention Description
Usual treatment of acute pulmonary oedema including : Oxygen, diuretic minimum one bolus IV of 40 mg FUROSEMIDE (LASILIX) possibility to repeat the dose every 15 minutes with a maximum 120 mg. Bolus of ISOSORBIDE DINITRATE (RISORDAN) of 1 mg maybe repeated every 3 minutes. As soon as possible perfusion of ISDN with flow adapted to the clinical status If necessary administration of DOBUTAMINE continuous perfusion of to 5 to 20 µg/kg/min.
Primary Outcome Measure Information:
Title
Composite criteria includes during the first 48 hours : death, tracheal intubation and mechanical ventilation rates, persistence of inclusion criteria for respiratory distress and shock until H2, reappearance of inclusion criteria after H2.
Time Frame
48 hours
Secondary Outcome Measure Information:
Title
brain natriuretic factor value curves from H0, H6 and H24; composite criteria without intubation rate; clinical and biological parameters evolution during the first 48 hours, myocardial infarction rate, CPAP non tol
Time Frame
H0, H6, H24, H48

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: age > 18 acute respiratory insufficiency with hypoxia in air KILLIP score from 2 to 4 absence of known ST elevation acute coronary syndrome accepted inform consent. Exclusion Criteria: age < 18 immediate intubation criteria (bradypnea, coma status) refractory shock
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
DUCROS Laurent, MD PhD
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
DUCROS Laurent
City
Paris
ZIP/Postal Code
75010
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
21805159
Citation
Ducros L, Logeart D, Vicaut E, Henry P, Plaisance P, Collet JP, Broche C, Gueye P, Vergne M, Goetgheber D, Pennec PY, Belpomme V, Tartiere JM, Lagarde S, Placente M, Fievet ML, Montalescot G, Payen D; CPAP collaborative study group. CPAP for acute cardiogenic pulmonary oedema from out-of-hospital to cardiac intensive care unit: a randomised multicentre study. Intensive Care Med. 2011 Sep;37(9):1501-9. doi: 10.1007/s00134-011-2311-4. Epub 2011 Jul 30.
Results Reference
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Continuous Positive Airway Pressure for Acute Pulmonary Edema

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