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

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01457898

Enrollment

Registered

2011-10-24

Start date

2008-04-30

Completion date

2009-05-31

Last updated

2011-10-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart; Dysfunction Postoperative, Cardiac Surgery

Keywords

Cardiac surgery, Non-invasive ventilation

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).

Interventions

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.

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to 85 Years

Healthy volunteers

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%)

Design outcomes

Primary

Measure	Time frame
Oxygenation index (PaO2/FiO2)	5 hours

Secondary

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

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026