Skip to main content
OpenTrials
Completed

NCT Number: NCT01457898

Non-invasive Mechanical Ventilation After Cardiac Surgery

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Heart; Dysfunction Postoperative, Cardiac Surgery

Age range

20 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Santa Casa de Misericórdia de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90020-090, Brazil

About this study

  • 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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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%)

Treatment and study plan

VPAP II®

Device

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

Other names: VPAP II -STA (Resmed®)

Primary outcomes

  1. Oxygenation index (PaO2/FiO2)

    Time frame: 5 hours

Secondary outcomes

  1. Heart rate (HR)

    Time frame: 5 hours

  2. Mean arterial pressure (MAP)

    Time frame: 5 hours

  3. Pulmonary capillary wedge pressure (PCWP)

    Time frame: 5 hours

  4. Cardiac output (CO)

    Time frame: 5 hours

Sponsors and collaborators

Lead sponsor

Irmandade Santa Casa de Misericórdia de Porto Alegre

Other

Collaborators

  • Federal University of Rio Grande do Sul

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Oct 24, 2011
Registry last updated
Oct 25, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.