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

NCT02977572 | Completed Results

• 1 other identifier: HGU Castellon-002
• Study Type: interventional
• Target: 114
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Cardiogenic Pulmonary Oedema

Keywords

Non-invasive ventilation,; continuous positive airway pressure; cardiogenic pulmonary oedema,; acute respiratory failure

Outcome Measures

Primary Outcomes (1)

• Need for an Endotracheal Intubation Within Seven Days After Onset of Cardiopulmonary Edema at the Intensive Care Unit

  Whitin seven days after onset of cardiopulmonary edema at the Intensive Care Unit

Secondary Outcomes (8)

• Duration of the Ventilation

  Time (hours) from start of ventilation until the removal of both devices because of improve or failure

• Ventilator Acquired Pneumonia

  Pulmonary infection at intensive care unit diagnosed until 72 hours after removal of ventilation

• Acute Renal Failure

  Acute Renal Failure during intensive care unit stay (at discharge from intensive care unit)

• Length of Stay at Intensive Care Unit

  Length of stay (days) at Intensive Care Unit at discharge from intensive care unit.

• Length of Hospital Stay

  Length of stay (days) at hospital at discharge from hospital

Study Arms (2)

Non-Invasive ventilation (NIV group)

EXPERIMENTAL

For the NIV group, a BiPAP Vision was used, by setting the Inspiratory Positive Airway Pressure (IPAP) at a level that was required to achieve a tidal volume of approximately 8-10 ml/kg. Also an Expiratory Positive Airway Pressure (EPAP) was set at a minimum of 5 cmH20 during the first hour, gradually increasing until there was a clinical improvement. Fraction inspiratory of oxygen (FiO2) was applied to maintain a transcutaneous arterial oxygen saturation (SaO2) of 92%-94%. NIV was continuously applied until there was a clinical and/or a gasometrical improvement, at which time they were replaced by a Venturi mask with FiO2 of 0.4.

Device: Non-Invasive Ventilation

Continuous Positive AirwayPressure CPAP

PLACEBO COMPARATOR

The CPAP was applied by using a flow generator with adjustable fractional inspired oxygen (FiO2). This was connected to the Positive End-Expiratory Pressure (PEEP) valve that was placed in the face mask. In the second instance, the CPAP system that was used was a Boussignac CPAP System Flow Jet. The Boussignac valve takes gas from a single source and splits it in order to create four high flow jets. These jets converge in the chamber creating a virtual valve. A initial level of 5cmH20 of PEEP was recommended for the first hour of ventilation, with subsequent increments (up to 15cmH20) until a clinical improvement was obtained. CPAP was continuously applied until there was a clinical and/or a gasometrical improvement, at which time it was replaced by a Venturi mask.

Device: Continuous Positive AirwayPressure CPAP

Interventions

Non-Invasive Ventilation DEVICE

In arm description

Non-Invasive ventilation (NIV group)

Continuous Positive AirwayPressure CPAP DEVICE

In arm description

Continuous Positive AirwayPressure CPAP

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Anatomical difficulty when adjusting the face mask, non-cardiogenic Acute Respiratory Failure (pneumonia, blunt chest trauma, or chronic obstructive pulmonary disease)
• Respiratory or cardiac arrest on admission, together with the need for an immediate intubation.
• Specific cardiac contraindications were also considered, including: cardiogenic shock on admission established by systolic blood pressure (SBP) \<90 mmHg, or a dependence on vasoactive drugs (norepinephrine \>0.5 µg/kg/min).

Sponsors & Collaborators

• Hospital General Universitario de Castellón: lead

MeSH Terms

Interventions

Noninvasive Ventilation

Intervention Hierarchy (Ancestors)

Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Results Point of Contact

• Title: Dr. Alberto Belenguer Muncharaz
• Organization: INTENSIVE CARE UNIT. HOSPITAL GENERAL UNIVERSITARI CASTELLO

belengueralberto8@gmail.com

0034-964-725000

Study Officials

• ALBERTO BELENGUER-MUNCHARAZ, MD

  INTENSIVE CARE UNIT. HOSPITAL GENERAL CASTELLO

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Phd, INTENSIVE CARE UNIT

Study Record Dates

• First Submitted: November 21, 2016
• First Posted: November 30, 2016
• Study Start: July 1, 2007
• Primary Completion: December 1, 2010
• Study Completion: January 1, 2011
• Last Updated: July 21, 2017
• Results First Posted: July 21, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will not share