Clinical Trials Directory

Trials / Completed

CompletedNCT01457898

Non-invasive Mechanical Ventilation After Cardiac Surgery

Effects of Non-invasive Mechanical Ventilation on Hemodynamics and Gas Exchanges Parameters After Cardiac Surgery in Patients With Relative Hypoxemia

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
42 (actual)
Sponsor
Irmandade Santa Casa de Misericórdia de Porto Alegre · Academic / Other
Sex
All
Age
20 Years – 85 Years
Healthy volunteers
Not accepted

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).

Conditions

Interventions

TypeNameDescription
DEVICEVPAP II®VPAP group:inspiratory pressure to generate 6ml/kg of weight and expiratory pressure of 7cmH2O plus oxygen therapy (FIO2=40%) during three hours.

Timeline

Start date
2008-04-01
Primary completion
2009-05-01
Completion
2009-05-01
First posted
2011-10-24
Last updated
2011-10-25

Locations

1 site across 1 country: Brazil

Source: ClinicalTrials.gov record NCT01457898. Inclusion in this directory is not an endorsement.