CClinicalTrials.gg
Sign In
CompletedNCT01457898Updated Oct 25, 2011

Non-invasive Mechanical Ventilation After Cardiac Surgery

An interventional study of VPAP II® in Heart; Dysfunction Postoperative, Cardiac Surgery, sponsored by Irmandade Santa Casa de Misericórdia de Porto Alegre. Completed at 1 site in Brazil. Open to participants aged 20 Years to 85 Years. Per ClinicalTrials.gov, last updated 2011-10-25.

Sponsored by Irmandade Santa Casa de Misericórdia de Porto Alegre · Not applicable and Interventional

Phase
Not applicable
Study type
Interventional
Enrollment
42
Allocation
Randomized
Ages
20 Years to 85 Years
Sex
All
01

Study 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.

Read the 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).
02

Conditions studied

  • Heart; Dysfunction Postoperative, Cardiac Surgery

Keywords

  • Cardiac surgery
  • Non-invasive ventilation
03

In context

Lead sponsor

Irmandade Santa Casa de Misericórdia de Porto Alegre is the lead sponsor of 8 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Invasive mechanical ventilation more than 24 hours
  • Serious obstructive pulmonary chronic disease (FEV1\<40%)
05

Study design

Phase
Not applicable
Allocation
Randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
42 participants (actual)

Study arms

  • Experimental
    VPAP II®

    VPAP II® Group

    Device: VPAP II®

Interventions

  • DeviceVPAP II®

    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®)

06

What researchers measure

Primary outcomes

  1. Oxygenation index (PaO2/FiO2)

    Time frame: 5 hours

Secondary outcomes

  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

07

Study locations

1 site
  • Santa Casa de Misericórdia de Porto Alegre
    Porto Alegre, Rio Grande do Sul 90020-090, Brazil
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 25, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01457898
Lead sponsor
Irmandade Santa Casa de Misericórdia de Porto Alegre
Collaborators
Federal University of Rio Grande do Sul
Responsible party
Alessandra Preisig (Principal Investigator, Irmandade Santa Casa de Misericórdia de Porto Alegre) — Principal investigator
First posted
Oct 24, 2011
Start date
Apr 2008
Primary completion
May 2009
Completion
May 2009
Last update
Oct 25, 2011

Study contacts

Alessandra P Werlang, MsC
principal investigator · Federal University of Rio Grande do Sul

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2011. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies from this sponsor

Irmandade Santa Casa de Misericórdia de Porto Alegre

Start the discussion