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Clinical Trials/NCT01457898
NCT01457898
Completed
Not Applicable

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

Irmandade Santa Casa de Misericórdia de Porto Alegre1 site in 1 country42 target enrollmentApril 2008

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Heart; Dysfunction Postoperative, Cardiac Surgery
Sponsor
Irmandade Santa Casa de Misericórdia de Porto Alegre
Enrollment
42
Locations
1
Primary Endpoint
Oxygenation index (PaO2/FiO2)
Status
Completed
Last Updated
14 years ago

Overview

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).

Registry
clinicaltrials.gov
Start Date
April 2008
End Date
May 2009
Last Updated
14 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Alessandra Preisig

Principal Investigator

Irmandade Santa Casa de Misericórdia de Porto Alegre

Eligibility Criteria

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%)

Outcomes

Primary Outcomes

Oxygenation index (PaO2/FiO2)

Time Frame: 5 hours

Secondary Outcomes

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

Study Sites (1)

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