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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:
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ISRCTN |
Last refreshed on:
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3 April 2017 |
Main ID: |
ISRCTN51523311 |
Date of registration:
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21/07/2016 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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The effectiveness of intensive chest physiotherapy for patients on mechanical ventilation in ICU
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Scientific title:
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Chest physiotherapy to improve extubation outcomes for critically ill patients with mechanical ventilation in ICU |
Date of first enrolment:
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24/10/2014 |
Target sample size:
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437 |
Recruitment status: |
Completed |
URL:
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http://isrctn.com/ISRCTN51523311 |
Study type:
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Interventional |
Study design:
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Single-centre prospective non-randomised study with retrospective case-note review (Treatment)
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Phase:
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Countries of recruitment
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Taiwan
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Contacts
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Name:
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Address:
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Telephone:
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Email:
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Affiliation:
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Name:
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Tsung-Hsien
Wang |
Address:
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Landseed Hospital
No.77, Guangtai Road
Pingzhen District
32449
Taoyuan City
Taiwan |
Telephone:
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+886 (0)3 4945353 |
Email:
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d03428002@ntu.edu.tw |
Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Aged 18 years and over 2. Admitted to the Landseed Hospital Intensive Care Unit 3. Require mechanical ventilation for at least 48 hours
Exclusion criteria: 1. Brain death patients 2. Ventilator-dependent patients 3. Tracheostomy patients 4. Patients receiving hospice care 5. Patients that have transferred during treatment
Age minimum:
Age maximum:
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Patients requiring mechanical ventilation Respiratory
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Intervention(s)
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Two groups of participants take part in this study.
Control group: Patients who previously received standard nursing care have their case notes from 2015 reviewed for extubation outcomes, mortality, hosptial transfers and clinic data (such as clinical diagnosis, Glasgow coma score, heart rate, blood pressure, respiratory rate, tidal volume,RSBI, length of stay, duration of mechanical ventilation and secretion volume). The results of this are then compared to the intervention group.
Intervention group: Participants take part in a a chest physiotherapy program, which consists of inspiratory muscle training, manual hyperinflation, chest wall mobilization, rib-cage compression, posture drainage, secretion removal, cough function training, extremity range of motion exercise. Rib cage compression consists of producing mechanical force transferred through the chest wall into the airways during the expiratory phase for the purpose of increasing and redirecting air flow, for pulmonary re-expansion and airway clearance. Manual hyperinflation was performed using a manual hyperinflation device with inspiratory pressure 40 cm H2O and FIO2 at 0.6, inducing a tidal volume increase and generating subsequent improvement in pulmonary compliance, inspiratory flow, and bronchial secretion clearance. During implementation of the techniques, SpO2 , heart rate, breathing frequency, and mean arterial pressure were monitored to control the effects while the protocol was performed. Early mobilization were also given by the physiotherapist according to patients’ conditions, vital signs, and clinical performance. These exercises started with sitting on the edge of the bed for moving their limbs, training for standing on their own, and moving off the bed to sit in a chair. Treatment takes place in 30-40 minute sessions once a day, five times a week, and treatments were given until the patient was discharged from the ICU. Extubation outcomes are determined according to observations by the at
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Primary Outcome(s)
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Extubation outcomes are determined by the attending physician observations (taken from medical records for control participants): 1. Extubation failure rate, defiened as the need for reintubation within 72 hours after extubation 2. Extubation rate, is calculated as extubation failure participants divided by all participants
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Secondary Outcome(s)
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Rapid Shallow Breathing Index is measured using a handheld spirometer attached to the endotracheal tube while the patient breathes room air for one minute without any ventilator assistance in the intervention group, and taken from medical records for control participants.
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Source(s) of Monetary Support
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Landseed Hospital
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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