Non-invasive Mechanical Ventilation After Cardiac Surgery

Not Applicable

Completed

• Conditions: Heart; Dysfunction Postoperative, Cardiac Surgery
• Interventions: Device: VPAP II®

• Registration Number: NCT01457898
• Lead Sponsor: Irmandade Santa Casa de Misericórdia de Porto Alegre

Brief Summary

Non-invasive mechanical ventilation (NIV) has been used in hypoxic post-operative cardiac patients but more studies are necessary to clarify its respiratory and hemodynamic effects. Therefore, the investigators objective was to study its effects in the oxygenation index (PaO2/FiO2) and in hemodynamic variables in this group of patients.

Detailed Description

* Postoperative cardiac surgery patients having a Swan-Ganz catheter and showing a PaO2/FiO2 between 150 and 300 (with FIO2 0.31), one hour after extubation, were included.

* Then, the patients were randomized into two groups: control and intervention group. Intervention group used NIV with a bi-level positive airway pressure (an inspiratory pressure to generate a tidal volume of 6ml/kg and an expiratory pressure of 7cmH2O) with a FIO2 0.4. Control group used oxygen by Venturi mask(FIO2 0.4) in order to keep a good oxygenation.

* In both groups measurements were done in basal situation, one and three hours after beginning the treatment and one hour after stop the treatment (FiO2 0.31).

* Variables studied included: PaO2/FiO2, PaO2, PaCO2, heart rate (HR), mean arterial pressure (MAP), pulmonary capillary wedge pressure (PCWP) and cardiac output (CO).

Study Timeline

• Study Start: 2008-04
• Primary Completion: 2009-05
• Study Completion: 2009-05
• Status Verified: 2011-10
• Study First Submitted: 2011-10-19
• Study First Submitted QC: 2011-10-20
• Last Update Submitted: 2011-10-21
• Study First Posted: 2011-10-24
• Last Update Posted: 2011-10-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

Inclusion Criteria

• Oxygenation index (PaO2/FiO2)between 150 and 300 one hour after extubation following cardiac surgery.
• Swan-Ganz catheter

Exclusion Criteria

• Invasive mechanical ventilation more than 24 hours
• Serious obstructive pulmonary chronic disease (FEV1<40%)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
VPAP II®	VPAP II®	VPAP II® Group

Primary Outcome Measures

Name	Time	Method
Oxygenation index (PaO2/FiO2)	5 hours

Secondary Outcome Measures

Name	Time	Method
Heart rate (HR)	5 hours
Mean arterial pressure (MAP)	5 hours
Pulmonary capillary wedge pressure (PCWP)	5 hours
Cardiac output (CO)	5 hours

Trial Locations

Locations (1)

Santa Casa de Misericórdia de Porto Alegre; 🇧🇷 Porto Alegre, Rio Grande do Sul, Brazil