Effectiveness Of Modified Chest PT Technidue In Pre And Post-Operative Program In Patients Open Heart Surgery

NCT02894879 | Unknown DMC

• 1 other identifier: Effect of modify chest PT
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to explore effectiveness of modified chest physical therapy techniques using new device in pre and post-operative program in patients undergoing open heart surgery

Conditions

Pulmonary Complications

Keywords

Postoperative pulmonary complications

Outcome Measures

Primary Outcomes (2)

• Incidence of PPCs,

  Incidence of PPCs were recorded from atelectasis, pneumonia, and pleural effusion according to clinical (symptoms and examinations) and radiological criteria in postoperative day 1-5 and diagnosed by the physician.

  postoperative day 1-5

• The duration of breathing with a mode of mechanical ventilator and duration of intubation time

  Duration of mode of mechanical ventilation and intubation times. Dependent variables, mode and duration of mechanical ventilation, starting records mode of mechanical ventilator when the patients arrive to ICU until extubation

  postoperative 4 weeks

Secondary Outcomes (2)

• length of ICU and hospital stay

  postoperative 4 weeks

• Pulmonary function test

  pre-operation and post-operative 1-5 days

Study Arms (2)

Modify group

EXPERIMENTAL

For 2 days pre-surgery and continuous post-surgery repeated for 5 sets a day. The patients in Modify group will be taught 4 modify techniques and receive cardiac rehabilitation phase 1 in postoperative period.

Device: BreatheMAX®

Conventional group

SHAM COMPARATOR

For 2 days pre-surgery and continuous post-surgery repeated for 5 sets a day. The patients in Modify group will be taught 3 conventional techniques and receive cardiac rehabilitation phase 1 in postoperative period.

Other: Routine treatment

Interventions

BreatheMAX® DEVICE

Modify chest physical therapy * oscillated incentive spirometry (OIS) with inspiratory load of 5-8 cm H2O 30 times/set * oscillated positive expiratory pressure (OPEP) with expiratory load of 5-8 cm H2O 30 times/set * Coughing with splinting 3 times/set * Chest mobilization with overhead both arms rises 10 times/set total 5 set/day

Modify group

Routine treatment OTHER

Routine chest physical therapy * Deep breathing exercise (upper and lower costal and diaphragmatic breathing exercise) as deep as possible for 10 times/set/level * Coughing with splinting 3 times/set * Chest mobilization with overhead both arms raised 10 times/set total 5 set/day

Conventional group

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with a leaky septal defect, valvular heart disease and coronary artery disease, both male, and female, scheduled for primary elective open heart surgery age 20-80 years who had the ability to communicate and understand informed consent.

You may not qualify if:

• Unstable angina pectoris at the moment of selection or during the program
• Complex ventricular and uncontrolled arrhythmia
• Uncontrolled high blood pressure (\> 140/90 mm/Hg)
• A history of cerebrovascular accident
• Presence of a neuromuscular disorder
• Cardiovascular instability or the existence an aneurysm
• Ejection fractions were less than 0.40
• Unable to participate because of physical limitations

Sponsors & Collaborators

• Khon Kaen University: lead

Study Sites (1)

Khon Kaen hospital

Maung Khon Kaen, KhonKaen, 40000, Thailand

RECRUITING

Study Officials

• Atidtaya yotwong, master

  Khon Kaen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Atidtaya yotwong, master

CONTACT

+66945423887; amaon21@gmail.com

Chulee Jones, doctor

CONTACT

+66845164169; joneschulee@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 15, 2016
• First Posted: September 9, 2016
• Study Start: September 1, 2016
• Primary Completion: April 1, 2017
• Study Completion: April 1, 2017
• Last Updated: October 14, 2016

Record last verified: 2016-10

Locations

TH (1)