We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Non-invasive Mechanical Ventilation After Cardiac Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01457898
Recruitment Status : Completed
First Posted : October 24, 2011
Last Update Posted : October 25, 2011
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Heart; Dysfunction Postoperative, Cardiac Surgery Device: VPAP II®

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).

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Effects of Non-invasive Mechanical Ventilation on Hemodynamics and Gas Exchanges Parameters After Cardiac Surgery in Patients With Relative Hypoxemia
Study Start Date : April 2008
Primary Completion Date : May 2009
Study Completion Date : May 2009

Resource links provided by the National Library of Medicine

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

Arms and Interventions

Arm Intervention/treatment
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®)


Outcome Measures

Primary Outcome Measures :
  1. Oxygenation index (PaO2/FiO2) [ Time Frame: 5 hours ]

Secondary Outcome Measures :
  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 ]

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   20 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: October 24, 2011    Key Record Dates
Last Update Posted: October 25, 2011
Last Verified: October 2011

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