Respiratory Physiotherapy After Cardiac Surgery | NCT01513642

Studies
Respiratory Physiotherapy After Cardiac Surgery

NCT01513642

Sponsor

Universidade Federal do Rio de Janeiro

Status

Completed

Last Update Posted

Jan 20, 2012Estimated

Enrollment

16Actual

Phase

Not Applicable

Conditions

Functional Disturbance Following Cardiac Surgery

Interventions

Breath Stacking

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

Jan 2012

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

Mar 2009

Primary Completion Date

Feb 2010Actual

Completion Date

Dec 2011Actual

First Submitted Date

Jan 16, 2012

First Submission Date that Met QC Criteria

Jan 19, 2012

First Posted Date

Jan 20, 2012Estimated

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

Jan 19, 2012

Last Update Posted Date

Jan 20, 2012Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Juliana Flávia de Oliveira, Inspiratory Volume and Muscle Recruitment During Breath-stacking and Incentive Spirometry Techniques in Postoperative Cardiac Patients., Universidade Federal do Rio de JaneiroPrincipal Investigator

Lead Sponsor

Universidade Federal do Rio de JaneiroOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

Although incentive spirometry is commonly used to avoid pulmonary complications in cardiac surgery patients, the breath-stacking technique has been proposed as an alternative to increase pulmonary volumes in the post-operative period.

Objective: To compare inspiratory volume and electromyographic activity of respiratory muscles during breath stacking technique and incentive spirometry in patients undergoing cardiac surgery.

Detailed Description

The purpose of the present study are:

to evaluate and compare the inspiratory volume during the course of Breath Stacking and Incentive Spirometry techniques in patients submitted to myocardial revascularization surgery.
to compare the electromyographic activity of the scalene, sternocleidomastoid (SCM) and diaphragm muscles during both techniques.

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

16Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Incentive spirometry	Other		Behavioral: Breath Stacking
Breath Stacking	No Intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Breath Stacking	Behavioral	To perform the BS maneuver, a silicone mask containing a one-way valve was attached to the patient's face. Once the mask was adjusted to allow only inspiration (the expiratory branch remained occluded), the patient was asked to make successive inspiratory efforts during 20 seconds.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Inspiratory volume and muscle recruitment during breath-stacking and incentive spirometry techniques in postoperative cardiac patients		Within 2 days after cardiac surgery

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients submitted to myocardial revascularization surgery

Exclusion Criteria:

cognitive impairment or incoordination to perform IS
face mask intolerance during BS
level of consciousness incompatible to perform IS
hemodynamic complications [arrhythmia, intraoperative myocardial infarction, major blood loss (defined as a loss of ≥20% of total blood volume), mean arterial pressure <70 mmHg and reduce cardiac output requiring the use of an intra-aortic balloon pump or vasoactive drugs)
intubation for more than 72 h after admission to the Intensive Care Unit
the need for reintubation.](streamdown:incomplete-link)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

70 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
Cristina Dias, PhD	Centro Universitário Augusto Motta	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Federal Bonsucesso Hospital		Rio de Janeiro	Rio de Janeiro	21041030	Brazil

Intervention Browse Module

MeSH Terms

ID	Term
D001945	Breathing Exercises

Ancestor Terms

ID	Term
D026441	Mind-Body Therapies
D000529	Complementary Therapies
D013812	Therapeutics
D026241	Exercise Movement Techniques

Browse Leaves

Not provided

Browse Branches

Not provided