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Non-invasive Mechanical Ventilation After Cardiac Surgery

NCT ID: NCT01457898

Last Updated: 2011-10-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-04-30

Study Completion Date

2009-05-31

Brief Summary

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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

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* 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).

Conditions

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Heart; Dysfunction Postoperative, Cardiac Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Study Groups

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VPAP II®

VPAP II® Group

Group Type EXPERIMENTAL

VPAP II®

Intervention Type DEVICE

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

Interventions

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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.

Intervention Type DEVICE

Other Intervention Names

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VPAP II -STA (Resmed®)

Eligibility Criteria

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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%)
Minimum Eligible Age

20 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Federal University of Rio Grande do Sul

OTHER

Sponsor Role collaborator

Irmandade Santa Casa de Misericórdia de Porto Alegre

OTHER

Sponsor Role lead

Responsible Party

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Alessandra Preisig

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Alessandra P Werlang, MsC

Role: PRINCIPAL_INVESTIGATOR

Federal University of Rio Grande do Sul

Locations

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Santa Casa de Misericórdia de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Site Status

Countries

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Brazil

Other Identifiers

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1751/07

Identifier Type: -

Identifier Source: org_study_id