- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06521346
Active Cycle Breathing Technique (ACBT) on Respiratory Parameters, Dyspnea Related Kinesiophobia and Pain ((ACBT))
The Effect of Active Cycle Breathing Technique on Respiratory Parameters, Dyspnea Related Kinesiophobia and Pain in Early Post Cardiac Surgery Patients
This study aims to improve pulmonary function impairment is associated with a reduction in chest expansion, lung volume, pain perception and an impairment of the Post cardiac surgery patient's ability to cough effectively. The technique of active cycle breathing consisted of three parts to the ACBT, which are:
- breathing control
- deep breaths
- huff or cough
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This study aims to explore the effect of Active Cycle Breathing Technique on Respiratory Parameters and Pain in Early Post Cardiac Surgery Patients
Research hypothesis:
-Post cardiac surgery patients who practice active breathing techniques exhibit an improvement in clinical outcomes compared to those who do not practice.
Research design:
A randomized control trial research design will be utilized to conduct this study.
Study Setting:
This study was carried out at the cardiac ICUs. A sample of 120 cardiac patients will be assigned in the current study from the previously mentioned settings.
The patients will be allocated into two equal groups, each with 60 patients. The control group will be composed of 60 patients who were managed by routine cardiac care The study group will consist of 60 patients who were exposed to an active cycle of breathing techniques
Inclusion criteria:
- Adult patients of both genders.
- After extubating for at least 6 hours
- Hemodynamic stable patients
- Able to communicate. Exclusion criteria: Patient with complication postoperative surgery Patient's demographic characteristics as patient's code, age, gender, marital status, education, and occupation.
Study group: managed by the use of active cycle breathing techniques combined with routine physiotherapy.
- Each session of the active cycle breathing technique lasted for 10 to 20 minutes.
- The active cycle breathing technique was carried out for three days post extubating four sessions done daily.
Implementation of active cycle breathing technique
- Explain the steps of ACBT to the patient.
The patient was placed in a semi-sitting position with her or his back straight, and instructions were given to the patient to do the following steps:
1 . Breathing control phase
- Hold the spirometer straight.
- Exhale, then seal your lips around the mouthpiece and inhale slowly and deeply into your mouth.
- The piston in the incentive spirometer's transparent chamber will rise when you inhale deeply.
- Hold your breath for 3 to 5 seconds after taking a deep breath.
- Remove the mouthpiece and slowly exhale. For a few seconds, until the piston descends to the bottom of the chamber, relax and breathe normally.
To regain control of their breathing, the patient was told to do lengthy, slow expirations between 5 and 7 times.
2 . Thoracic expansion exercises The patient was instructed to relax your upper chest.
- The patient was instructed to breathe slowly and deeply through the nose without using the accessory muscle.
- The patient was instructed to hold their breath initially for 3 to 4 seconds and gradually increase it to the maximum time.
Don't force the breath out; instead, softly exhale through pursed lips until your lungs are empty.
- Repeat the previous steps from 3to4 times. 3- Forced expiration technique (huffing)
- Patient was instructed to support the incision site by using a chest binder or keeping your hands over your incision.
- Cough twice as many times as they huffed two to three times.
- This step was repeated a minimum of two times and a maximum of three times in one session.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Damanhūr, Egypt
- Faculty of nursing Damanhour university
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Adult patients of both genders.
- After extubating for at least 6 hours post operation.
- Hemodynamic stable patients
- Able to communicate.
Exclusion Criteria:
- Instability of patient's medical condition or hemodynamic instability
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Active cycle breathing technique
Breathing control phase Thoracic expansion exercises Forced expiration technique (huffing)
|
The ACBT was included if it was described as containing three essential components: 1) breathing control, 2) forced expiration technique and 3) thoracic expansion exercises.
The technique may also include postural drainage (PD) or percussion/shaking.
|
|
Placebo Comparator: Control group
Patient who receives the routine care
|
Routine care delivers after extubating such as percussion or chest physiotherapy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain perception
Time Frame: Three observation days
|
Using visual analogue scale score 0 mean no pain while score 10 means sever pain
|
Three observation days
|
|
Dyspnea-related kinesiophobia
Time Frame: preoperative, three observation days, and day of discharge
|
comprises 11 items include five items dyspnea and six items for fear of activity dimension and each item is rated from "strongly disagree" (score = 1) to "strongly agree" (score = 5) for a total score between 11 and 55.
|
preoperative, three observation days, and day of discharge
|
|
Respiratory parameters
Time Frame: Three observation days
|
change in respiratory rate
|
Three observation days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Deterioration in clinical parameters such as vital signs
Time Frame: Three observation days
|
hypoxic event
|
Three observation days
|
|
ICU and hospital stay
Time Frame: three observation days
|
ICU and hospital stay
|
three observation days
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Lewis LK, Williams MT, Olds TS. The active cycle of breathing technique: a systematic review and meta-analysis. Respir Med. 2012 Feb;106(2):155-72. doi: 10.1016/j.rmed.2011.10.014. Epub 2011 Nov 18.
- Mckoy NA, Wilson LM, Saldanha IJ, Odelola OA, Robinson KA. Active cycle of breathing technique for cystic fibrosis. Cochrane Database Syst Rev. 2016 Jul 5;7(7):CD007862. doi: 10.1002/14651858.CD007862.pub4.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Active cycle breath technique
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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