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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01457898
Other study ID # 1751/07
Secondary ID
Status Completed
Phase N/A
First received October 19, 2011
Last updated October 21, 2011
Start date April 2008
Est. completion date May 2009

Study information

Verified date October 2011
Source Irmandade Santa Casa de Misericórdia de Porto Alegre
Contact n/a
Is FDA regulated No
Health authority Brazil: National Committee of Ethics in Research
Study type Interventional

Clinical Trial 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.


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).


Recruitment information / eligibility

Status Completed
Enrollment 42
Est. completion date May 2009
Est. primary completion date May 2009
Accepts healthy volunteers No
Gender Both
Age group 20 Years to 85 Years
Eligibility 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%)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label


Related Conditions & MeSH terms

  • Heart; Dysfunction Postoperative, Cardiac Surgery

Intervention

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.

Locations

Country Name City State
Brazil Santa Casa de Misericórdia de Porto Alegre Porto Alegre Rio Grande do Sul

Sponsors (2)

Lead Sponsor Collaborator
Irmandade Santa Casa de Misericórdia de Porto Alegre Federal University of Rio Grande do Sul

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary Oxygenation index (PaO2/FiO2) 5 hours Yes
Secondary Heart rate (HR) 5 hours Yes
Secondary Mean arterial pressure (MAP) 5 hours Yes
Secondary Pulmonary capillary wedge pressure (PCWP) 5 hours Yes
Secondary Cardiac output (CO) 5 hours Yes
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