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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Non-Invasive Mechanical Ventilation Versus Continuous Positive Airway Pressure Relating to Cardiogenic Pulmonary Edema in an Intensive Care Unit

Brief 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.

Detailed Summary:

Continuous Positive Airway Pressure (CPAP) and Non-Invasive Ventilation (NIV), has played a decisive role in the treatment of Acute Respiratory Failure (ARF) secondary to Cardiogenic Pulmonary Edema (CPE). The use of either CPAP or NIV has resulted in greater clinical improvements than the ones that have been previously obtained by using a standard medical therapy. Although there is a strong indication for NIV in hypercapnic patients, the situation whether NIV is superior to CPAP remains unclear, and hence, both have been recommended.

NIV and CPAP have both been successfully used in patients admitted to an Intensive Care Unit (ICU) suffering from CPE. However, few trials have been published on the ICU scenario. In addition, Acute Coronary Syndrome (ACS) has been considered to be an exclusion criterion in several trials.

At the time of the onset of CPE, either in the Emergency Department (ED) or in the ward, all participants received a standard medical therapy (oxygen through a Venturi mask, morphine, intravenous nitroglycerin if their systolic blood pressure >160 mmHg, together with loop diuretics), all at the discretion of the attending physician. In the absence of a clinical improvement [dyspnea, respiratory rate >25rpm, transcutaneous arterial oxygen saturation (SaO2) <90%], the participant was admitted to the ICU and assigned to the NIV group or the CPAP group, regardless of the treatment that they had received in the ED. The participants that were admitted to the ICU at the onset of CPE were randomised without a trial of medical treatment. The assignment of each group was performed by opening a sealed envelope following a prior randomisation by using a computerised system.

Statistical. Based upon previous results, the investigators considered that the need for
Sponsor: Hospital General Universitario de Castellón

Current Primary Outcome: Reduction in the need for an endotracheal intubation in an NIV group [ Time Frame: Whitin seven days after onset of cardiopulmonary edema at the Intensive Care Unit ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Hospital General Universitario de Castellón

Dates:
Date Received: November 21, 2016
Date Started: July 2007
Date Completion:
Last Updated: November 25, 2016
Last Verified: November 2016