Ignite Creation Date:
2024-05-05 @ 5:09 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00390442
Status:
COMPLETED
Last Update Posted:
2006-10-19
First Post:
2006-10-17
Brief Title:
Out-of-Hospital CPAP for Severe Cardiogenic Pulmonary Edema
Sponsor:
Hopital Lariboisière
Organization:
Hopital Lariboisière
Study Overview
Official Title:
Effect of Continuous Positive Airway Pressure as a First Line Therapy in Out-of-Hospital Management of Severe Cardiogenic Pulmonary Edema
Status:
COMPLETED
Status Verified Date:
2006-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
In cardiogenic pulmonary edema Continuous Positive Airway Pressure CPAP added to medical treatment improves outcome The present study was designed to assess the benefit of CPAP as a first line treatment of cardiogenic pulmonary edema in the out-of-hospital environment
Detailed Description:
Cardiogenic pulmonary edema CPE is a frequent presenting process for acute out-of-hospital practice Acute left heart failure may occur from a variety of processes that rapidly deteriorates to this generalized cardiopulmonary disorder The classical treatment of out-of-hospital CPE includes supplemental oxygen vasodilators loop diuretics and morphine If not effective or because of the associated respiratory depression tracheal intubation and mechanical ventilation are often needed which by themselves are associated with a worse prognosis Continuous positive airway pressure CPAP has been proposed as an alternative to mechanical ventilation in CPE This technique not only improves alveolar recruitment and decreases the work of breathing 4 but also reduces left ventricular afterload and both right and left ventricular preload The overall effect of CPAP in the acute management of CPE is to improve cardio-respiratory function and sustained tissue oxygenation Furthermore the combination of CPAP with medical treatment in patients with CPE significantly reduces the need for intubation and improves the outcome
Unfortunately very limited data are available on the effects of CPAP in the out-of-hospital practice Thus we tested the potential benefit of immediate use of CPAP alone in comparison with pharmacological therapy in treatment of CPE in the acute out-of-hospital environment
The protocol lasts 45 minutes divided into 3 periods of 15 minutes Patients with severe pulmonary edema are randomly assigned in 2 groups 1 Early CPAP n63 CPAP alone T0-T15 CPAP medical treatment T15-T30 medical treatment alone T30-T45 2 Late CPAP n61 medical treatment alone T0-T15 medical treatment CPAP T15-T30 medical treatment alone T30-T45 Primary endpoint effect of early CPAP on a dyspnea clinical score and on arterial blood gases Secondary endpoints incidence of tracheal intubation inotropic support and in-hospital mortality
Unfortunately very limited data are available on the effects of CPAP in the out-of-hospital practice Thus we tested the potential benefit of immediate use of CPAP alone in comparison with pharmacological therapy in treatment of CPE in the acute out-of-hospital environment
The protocol lasts 45 minutes divided into 3 periods of 15 minutes Patients with severe pulmonary edema are randomly assigned in 2 groups 1 Early CPAP n63 CPAP alone T0-T15 CPAP medical treatment T15-T30 medical treatment alone T30-T45 2 Late CPAP n61 medical treatment alone T0-T15 medical treatment CPAP T15-T30 medical treatment alone T30-T45 Primary endpoint effect of early CPAP on a dyspnea clinical score and on arterial blood gases Secondary endpoints incidence of tracheal intubation inotropic support and in-hospital mortality
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None