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Non-invasive Mechanical Ventilation After Cardiac Surgery

This study has been completed.
Sponsor:
Collaborator:
Federal University of Rio Grande do Sul
Information provided by (Responsible Party):
Alessandra Preisig, Irmandade Santa Casa de Misericórdia de Porto Alegre
ClinicalTrials.gov Identifier:
NCT01457898
First received: October 19, 2011
Last updated: October 21, 2011
Last verified: October 2011
History of Changes
  Purpose

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.


Condition Intervention
Heart; Dysfunction Postoperative, Cardiac Surgery
 Device: VPAP II®

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Effects of Non-invasive Mechanical Ventilation on Hemodynamics and Gas Exchanges Parameters After Cardiac Surgery in Patients With Relative Hypoxemia

Resource links provided by NLM:

MedlinePlus related topics: Heart Surgery
U.S. FDA Resources

Further study details as provided by Irmandade Santa Casa de Misericórdia de Porto Alegre:

Primary Outcome Measures:
  • Oxygenation index (PaO2/FiO2) [ Time Frame: 5 hours ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Heart rate (HR) [ Time Frame: 5 hours ] [ Designated as safety issue: Yes ]
  • Mean arterial pressure (MAP) [ Time Frame: 5 hours ] [ Designated as safety issue: Yes ]
  • Pulmonary capillary wedge pressure (PCWP) [ Time Frame: 5 hours ] [ Designated as safety issue: Yes ]
  • Cardiac output (CO) [ Time Frame: 5 hours ] [ Designated as safety issue: Yes ]

Enrollment: 42
Study Start Date: April 2008
Study Completion Date: May 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: VPAP II®
VPAP II® Group
 Device: VPAP II®
VPAP group:inspiratory pressure to generate 6ml/kg of weight and expiratory pressure of 7cmH2O plus oxygen therapy (FIO2=40%) during three hours.
Other Name: VPAP II -STA (Resmed®)

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).
  Eligibility

Ages Eligible for Study:   20 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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%)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01457898

Locations
Brazil
Santa Casa de Misericórdia de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil, 90020-090
Sponsors and Collaborators
Irmandade Santa Casa de Misericórdia de Porto Alegre
Federal University of Rio Grande do Sul
Investigators
Principal Investigator: Alessandra P Werlang, MsC Federal University of Rio Grande do Sul
  More Information

No publications provided

Responsible Party: Alessandra Preisig, Principal Investigator, Irmandade Santa Casa de Misericórdia de Porto Alegre
ClinicalTrials.gov Identifier: NCT01457898     History of Changes
Other Study ID Numbers: 1751/07
Study First Received: October 19, 2011
Last Updated: October 21, 2011
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Irmandade Santa Casa de Misericórdia de Porto Alegre:
Cardiac surgery
Non-invasive ventilation

ClinicalTrials.gov processed this record on May 16, 2013