NCT01457898

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2008

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2008

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2009

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

October 19, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 24, 2011

Completed
Last Updated

October 25, 2011

Status Verified

October 1, 2011

Enrollment Period

1.1 years

First QC Date

October 19, 2011

Last Update Submit

October 21, 2011

Conditions

Heart; Dysfunction Postoperative, Cardiac Surgery

Keywords

Cardiac surgeryNon-invasive ventilation

Outcome Measures

Primary Outcomes (1)

  • Oxygenation index (PaO2/FiO2)

    5 hours

Secondary Outcomes (4)

  • Heart rate (HR)

    5 hours

  • Mean arterial pressure (MAP)

    5 hours

  • Pulmonary capillary wedge pressure (PCWP)

    5 hours

  • Cardiac output (CO)

    5 hours

Study Arms (1)

VPAP II®

EXPERIMENTAL

VPAP II® Group

Device: VPAP II®

Interventions

VPAP II®DEVICE

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

Also known as: VPAP II -STA (Resmed®)
VPAP II®

Eligibility Criteria

Age20 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Oxygenation index (PaO2/FiO2)between 150 and 300 one hour after extubation following cardiac surgery.
  • Swan-Ganz catheter

You may not qualify if:

  • Invasive mechanical ventilation more than 24 hours
  • Serious obstructive pulmonary chronic disease (FEV1\<40%)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Santa Casa de Misericórdia de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90020-090, Brazil

Location

Study Officials

  • Alessandra P Werlang, MsC

    Federal University of Rio Grande do Sul

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 19, 2011

First Posted

October 24, 2011

Study Start

April 1, 2008

Primary Completion

May 1, 2009

Study Completion

May 1, 2009

Last Updated

October 25, 2011

Record last verified: 2011-10

Locations

BR(1)