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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01513642
Other study ID # oliveira1
Secondary ID
Status Completed
Phase N/A
First received January 16, 2012
Last updated January 19, 2012
Start date March 2009
Est. completion date December 2011

Study information

Verified date January 2012
Source Universidade Federal do Rio de Janeiro
Contact n/a
Is FDA regulated No
Health authority Brazil: Ministry of Health
Study type Interventional

Clinical Trial 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.


Description:

The purpose of the present study are:

1. to evaluate and compare the inspiratory volume during the course of Breath Stacking and Incentive Spirometry techniques in patients submitted to myocardial revascularization surgery.

2. to compare the electromyographic activity of the scalene, sternocleidomastoid (SCM) and diaphragm muscles during both techniques.


Recruitment information / eligibility

Status Completed
Enrollment 16
Est. completion date December 2011
Est. primary completion date February 2010
Accepts healthy volunteers No
Gender Both
Age group 50 Years to 70 Years
Eligibility 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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Behavioral:
Breath Stacking
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.

Locations

Country Name City State
Brazil Federal Bonsucesso Hospital Rio de Janeiro

Sponsors (1)

Lead Sponsor Collaborator
Universidade Federal do Rio de Janeiro

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary Inspiratory volume and muscle recruitment during breath-stacking and incentive spirometry techniques in postoperative cardiac patients Within 2 days after cardiac surgery Yes