NCT01513642

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2009

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2009

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2010

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 16, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 20, 2012

Completed
Last Updated

January 20, 2012

Status Verified

January 1, 2012

Enrollment Period

11 months

First QC Date

January 16, 2012

Last Update Submit

January 19, 2012

Conditions

Keywords

physiotherapycardiac surgerybreath Stacking

Outcome Measures

Primary Outcomes (1)

  • Inspiratory volume and muscle recruitment during breath-stacking and incentive spirometry techniques in postoperative cardiac patients

    Within 2 days after cardiac surgery

Study Arms (2)

Incentive spirometry

OTHER
Behavioral: Breath Stacking

Breath Stacking

NO INTERVENTION

Interventions

Breath StackingBEHAVIORAL

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.

Also known as: respiratory exercises
Incentive spirometry

Eligibility Criteria

Age50 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients submitted to myocardial revascularization surgery

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Federal Bonsucesso Hospital

Rio de Janeiro, Rio de Janeiro, 21041030, Brazil

Location

MeSH Terms

Interventions

Breathing Exercises

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsExercise Movement TechniquesPhysical Therapy Modalities

Study Officials

  • Cristina Dias, PhD

    Centro Universitário Augusto Motta

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Inspiratory Volume and Muscle Recruitment During Breath-stacking and Incentive Spirometry Techniques in Postoperative Cardiac Patients.

Study Record Dates

First Submitted

January 16, 2012

First Posted

January 20, 2012

Study Start

March 1, 2009

Primary Completion

February 1, 2010

Study Completion

December 1, 2011

Last Updated

January 20, 2012

Record last verified: 2012-01

Locations