Continuous Positive Airway Pressure for Acute Pulmonary Edema
Information source: Assistance Publique - Hôpitaux de Paris
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pulmonary Edema; Dyspnea; Paroxysmal; Congestive Heart Failure
Intervention: Continuous Positive Airway Pressure (CPAP) (Procedure); usual care of acute pulmonary oedema (Procedure)
Phase: Phase 3
Status: Recruiting
Sponsored by: Assistance Publique - Hôpitaux de Paris Official(s) and/or principal investigator(s):
DUCROS Laurent, MD PhD, Principal Investigator, Affiliation: Assistance Publique - Hôpitaux de Paris
Overall contact:
DUCROS Laurent, MD Phd, Phone: +33(1) 49 95 61 61, Email: laurent.ducros@lrb.aphp.fr
Summary
We hypothesise that CPAP + pharmaceutical treatment, compared to pharmaceutical treatment
alone, improve 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.
Clinical Details
Official title: Effect of Continuous Positive Airway Pressure on Short Term Inhospital Prognosis for Acute Pulmonary Edema
Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Primary outcome: 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: 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
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- age > 18
- acute respiratory insufficiency with hypoxia in air
- KILLIP score from 2 to 4
- absence of sus ST elevation acute coronary syndrome
- accepted inform consent.
Exclusion Criteria:
- age < 18
- immediate intubation criteria (bradypnea, coma status)
- refractory shock
Locations and Contacts
DUCROS Laurent, MD Phd, Phone: +33(1) 49 95 61 61, Email: laurent.ducros@lrb.aphp.fr
DUCROS Laurent, Paris 75010, France; Recruiting
DUCROS Laurent, MD PhD
Hôpital Lariboisière - Cardiologie, Paris 75010, France; Recruiting
HENRY Patrick, Pr, Phone: 33-1 49.95.82.24
HENRY Patrick, Pr, Principal Investigator
Hopital Pitié Salpétrière-DAR-SMUR, Paris 75013, France; Recruiting
ECOLLAN Patrick, Pr, Phone: 33-1 42 16 22 53
Hopital Beaujon-DAR-SMUR, Clichy 92110, France; Recruiting
BELPOMME Vanessa, Pr, Phone: 33-1 40 87 59 13
Hopital Beaujon-Cardiologie, Clichy 92110, France; Recruiting
LOGEART Damien, Dr, Phone: 33-1 40 8758 92
Hopital Necker-SAMU75-SMUR, Paris 75015, France; Recruiting
JANNIERE Daniel, Pr, Phone: 33-1 44 49 24 73
Hopital Europeen Georges Pompidou-Cardiologie, Paris 75015, France; Recruiting
BENSOUDA Christophe, Pr, Phone: 33-1 56 09 28 51
Chu- Samu 29, Brest 29200, France; Recruiting
VERGNE Muriel, Dr, Phone: 33-2 98 34 79 00
CHU Brest- UHCD, Brest 29200, France; Recruiting
L'HER Erwan, Pr, Phone: 33-2 98 34 71 81
CHU Brest-Cardiologie, Brest 29200, France; Recruiting
BLANC Jean Jaques, Pr, Phone: 33-2 98 34 71 86
CHR-SAMU 45, Orleans La Source 45100, France; Recruiting
LAGARDE Sophie, Dr, Phone: 33-2 38 66 85 26
CHR6Cardiologie, Orleans La Source 45100, France; Recruiting
DIBON Olivier, Phone: 33-2 38 51 48 04
Clinique de la Reine Blanche-Cardiologie, Orleans 45100, France; Recruiting
PLACENTE Marius, Dr, Phone: 33-2 38 79 83 83
CH Delafontaine-SMUR, Saint Denis 93, France; Recruiting
HENNEQUIN Brigitte, Phone: 33-1 42 35 61 40
CH Delafontaune-Réanimation médicale, Saint Denis 93, France; Recruiting
ADRIE Christophe, Phone: 33-1 42 35 61 40 Bip 046
Hopital Simone Veil-SMUR, Eaubonne 95600, France; Recruiting
EL SAYED KAMEL Mohamed, Pr, Phone: 33-6 63 54 73 54
CH-SMUR, Montfermeil 93370, France; Recruiting
CAVAGNA Patrick, Dr, Phone: 33-1 41 70 80 00
CH-Cardiologie, Montfermeil 93370, France; Recruiting
NALLET Olivier, Dr, Phone: 33-1 41 70 81 01
MICHAUD Pierre, Dr, Phone: 33-1 41 70 81 01
CH-Urgences-SMUR, Beziers 34543, France; Recruiting
FREDERIQUE Charles, Dr, Phone: 33-4 67 35 70 96
Hopital Simone Veil-Cardiologie, Eaubonne 95600, France; Recruiting
GHANEM Nachwan, Dr, Phone: 33-1 34 06 60 00 Bip 7278
Hopital Foch- Cardiologie, Suresnes 92, France; Recruiting
HAZIZA Franck, Dr, Phone: 33-1 46 25 24 68
Additional Information
Starting date: October 2004
Ending date: March 2008
Last updated: December 20, 2007
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