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Non-invasive Mechanical Ventilation After Cardiac Surgery

I

Irmandade Santa Casa de Misericórdia de Porto Alegre

Status

Completed

Conditions

Heart; Dysfunction Postoperative, Cardiac Surgery

Treatments

Device: VPAP II®

Study type

Interventional

Funder types

Other

Identifiers

NCT01457898
1751/07

Details and patient eligibility

About

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.

Full 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).

Enrollment

42 patients

Sex

All

Ages

20 to 85 years old

Volunteers

No 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%)

Trial design

42 participants in 1 patient group

VPAP II®
Experimental group
Description:
VPAP II® Group
Treatment:
Device: VPAP II®

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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