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Continuous Positive Airway Pressure for Acute Pulmonary Edema

NCT00554580 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 208

Last updated 2010-03-30

No results posted yet for this study

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.

Conditions

  • Pulmonary Edema
  • Dyspnea
  • Paroxysmal
  • Congestive Heart Failure

Interventions

PROCEDURE

Continuous Positive Airway Pressure (CPAP)

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.

PROCEDURE

usual care of acute pulmonary oedema

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.

Sponsors & Collaborators

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • DUCROS Laurent, MD PhD · Assistance Publique - Hôpitaux de Paris

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-10-31
Primary Completion
2008-07-31
Completion
2008-07-31

Countries

  • France

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00554580 on ClinicalTrials.gov