Non-invasive Mechanical Ventilation After Cardiac Surgery

Heart; Dysfunction Postoperative, Cardiac Surgery Clinical Trial

Official title:

Effects of Non-invasive Mechanical Ventilation on Hemodynamics and Gas Exchanges Parameters After Cardiac Surgery in Patients With Relative Hypoxemia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01457898
• Other study ID #: 1751/07
• 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