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N/A N=114 Randomized Treatment

Non-invasive Ventilation Versus Continuous Positive Airway Pressure in Cardiogenic Pulmonary Edema

Cardiogenic Pulmonary Oedema

Enrolled (actual)
114
Serious AEs
Results posted
Jul 2017
Primary outcome: Primary: Need for an Endotracheal Intubation Within Seven Days After Onset of Cardiopulmonary Edema at the Intensive Care Unit — 5; 5 Participants — p=1.000

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Non-Invasive Ventilation (Device); Continuous Positive AirwayPressure CPAP (Device)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Hospital General Universitario de Castellón
Primary completion
Dec 2010

Outcome Measures

OutcomeResultp-value
PRIMARY
Need for an Endotracheal Intubation Within Seven Days After Onset of Cardiopulmonary Edema at the Intensive Care Unit
5; 5 1.000
SECONDARY
Duration of the Ventilation
16; 10
SECONDARY
Ventilator Acquired Pneumonia
3; 1
SECONDARY
Acute Renal Failure
12; 13
SECONDARY
Length of Stay at Intensive Care Unit
3; 4
SECONDARY
Length of Hospital Stay
12; 14
SECONDARY
Intensive Care Unit Mortality
12; 14
SECONDARY
28th Day Mortality
13; 16
SECONDARY
Hospital Mortality
15; 17

Summary

The aim of the present study was to demonstrate that an Non-Invasive Ventilation (NIV) performs better than a Continuous Positive Airway Pressure (CPAP) in the management of Cardiogenic Pulmonary Edema (CPE) within an Intensive Care Unit (ICU) setting.

Eligibility Criteria

Inclusion Criteria

  • Participants suffering from CPE, defined as having the presence of dyspnea, respiratory rate >25 breaths/minute, the use of accessory respiratory muscles, cyanosis, cold sweats, bilateral crackles and/or wheezing on pulmonary auscultation, hypoxaemia, hypertension, and a predominance of bilateral pulmonary infiltrates upon a chest radiography (if available).
  • The potential causes of CPE have been understood to be Acute Coronary Syndrome (ACS) with or without a persistent ST-segment elevation, hypertensive emergency, valvulopathy, acute arrhythmia, endocarditis, or decompensation due to a chronic heart failure.

Exclusion Criteria

  • The exclusion criteria were: a refused consent, the patient's inability to cooperate, severe encephalopathy (Glasgow Coma Score 0.5 µg/kg/min).
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02977572). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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