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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: TCTR
Last refreshed on: 29 April 2024
Main ID:  TCTR20150127002
Date of registration: 27/01/2015
Prospective Registration: Yes
Primary sponsor: Khon Kaen University
Public title: Comparison of the effectiveness of traditional chest physiotherapy and vibrator assisted secretion clearance after infant and pediatric heart surgery using computer aided lung sound analysis
Scientific title: Comparison of the effectiveness of traditional chest physiotherapy and vibrator assisted secretion clearance after infant and pediatric heart surgery using computer aided lung sound analysis
Date of first enrolment: 09/02/2015
Target sample size: 100
Recruitment status: Active, not recruiting
URL:  https://www.thaiclinicaltrials.org/show/TCTR20150127002
Study type:  Interventional
Study design:  Randomized  
Phase:  N/A
Countries of recruitment
Thailand
Contacts
Name: Surussawadi    Bennett
Address:  Faculty of Associated Medical Sciences, Khon Kaen University, Khon Kaen, Thailand, 40002 40002 Khon Kaen Thailand
Telephone: +66833573119
Email: surmac@kku.ac.th
Affiliation:  Khon Kaen University
Name: Surussawadi    Bennett
Address:  Faculty of Associated Medical Sciences, Khon Kaen University, Khon Kaen, Thailand, 40002 40002 Khon Kaen Thailand
Telephone: +66833573119
Email: surmac@kku.ac.th
Affiliation:  Khon Kaen University
Key inclusion & exclusion criteria
Inclusion criteria: 1. Infant or paediatrics age between 3 month and 6 years after cardiac surgery
2. Secretion obstruction in the lungs from chest X-ray and physiotherapy objective examination
3. Spontaneous breathing in room air or with oxygen
4. Stable vital sign from nurse note

Exclusion criteria: 1. Surgical complication such as bleeding, pulmonary hypertension and instability of vital sign
2. Low platelet or coagulopathy
3. Osteoporosis
4. Severe bronchospasm
5. Chest pain


Age minimum: 3 Months
Age maximum: 6 Years
Gender: Both
Health Condition(s) or Problem(s) studied
secretion obstruction after heart surgery
Intervention(s)
postural drainage, percussion and vibration by a physiotherapist,vibrator
Traditional chest physiotherapy,Vibrator assisted secretion clearance
Active Comparator Other,Active Comparator Device
Primary Outcome(s)
crackle characteristics 2 minutes computer aided lung sound analysis
Secondary Outcome(s)
heart rate, oxygen saturation, EKG 5 minutes pulse oximeter, EKG monitoring
Secondary ID(s)
IRB00001189
Source(s) of Monetary Support
Khon Kaen University
Secondary Sponsor(s)
Faculty of Associated Medical Sciences
Ethics review
Status: Submitted, approved
Approval date:
Contact:
The Khon Kaen University Ethics Committee for Human Research, Panel 1
+66897141913 Ext. -
Results
Results available:
Date Posted:
Date Completed: 09/02/2018
URL:
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