Non-invasive Mechanical Ventilation After Cardiac Surgery | NCT01457898

Studies
Non-invasive Mechanical Ventilation After Cardiac Surgery

NCT01457898

Sponsor

Irmandade Santa Casa de Misericórdia de Porto Alegre

Status

Completed

Last Update Posted

Oct 25, 2011Estimated

Enrollment

42Actual

Phase

Not Applicable

Conditions

Heart; Dysfunction Postoperative, Cardiac Surgery

Interventions

VPAP II®

Countries

Brazil

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2008

Primary Completion Date

May 2009Actual

Completion Date

May 2009Actual

First Submitted Date

Oct 19, 2011

First Submission Date that Met QC Criteria

Oct 20, 2011

First Posted Date

Oct 24, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 21, 2011

Last Update Posted Date

Oct 25, 2011Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Alessandra Preisig, Principal Investigator, Irmandade Santa Casa de Misericórdia de Porto AlegrePrincipal Investigator

Lead Sponsor

Irmandade Santa Casa de Misericórdia de Porto AlegreOTHER

Collaborators

Name	Class
Federal University of Rio Grande do Sul	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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).

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

42Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
VPAP II®	Experimental	VPAP II® Group	Device: VPAP II®

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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.	VPAP II®

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Oxygenation index (PaO2/FiO2)		5 hours

Secondary Outcomes

Measure	Description	Time Frame
Heart rate (HR)		5 hours
Mean arterial pressure (MAP)		5 hours
Pulmonary capillary wedge pressure (PCWP)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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%)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Alessandra P Werlang, MsC	Federal University of Rio Grande do Sul	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Santa Casa de Misericórdia de Porto Alegre		Porto Alegre	Rio Grande do Sul	90020-090	Brazil