The Effect of Semi-recumbent Position With Exercise Training on Long-term Ventilator-dependent Patients

Study Overview
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Brief Summary
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Prolonged mechanical ventilation patients rely on medical expenses per year had increased by nearly 20 billion in 15 years, so it is worthwhile to explore how to improve the respiratory function and even their quality of life of patients in Respiratory care wards (RCWs). This study used repeated experimental measurements and purpose sampling, and the investigators invited patients in respiratory care ward in northern Taiwan. They were randomly assigned to the experimental group and the control group. The experimental group was given 45 degree Semi-sitting 2 hrs and upper-limb exercise training 10 mins once a day. There were 29 prolonged mechanical ventilation (PMV) patients in the experimental group and 26 in the control group. Our conclusions showed that PMV patients can significantly improve the maximum inspiratory pressure (MIP) in the post-test while performed a 45-degree semi-sitting position with upper limb training for 4 weeks. The minute ventilation (MV) has a trend of increasing month by month in the experimental group, but it is necessary to consider whether it is due to the improvement of lung function or just cause of the increased oxygen consumption and accelerated respiratory rate, so it can not be inferred to improvement of the patient's condition or lung function.

Detailed Description
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Background: Prolonged mechanical ventilation patients rely on medical expenses per year had increased by nearly 20 billion in 15 years. However, the high cost shows the high morbidity rate, high mortality rate and low ventilator weaning rate of prolonged mechanical ventilation patients, so it is worthwhile to explore how to improve the respiratory function and even their quality of life of patients in the respiratory care ward (RCW). OBJECTIVE: To investigate the improvement of respiratory function and the effect of respirator detachment in 45-degree semi-sitting and upper limb training, and to understand the correlation between this training activity and death risk. METHODS: This study used repeated experimental measurements and purpose sampling, and the investigators invited patients in the respiratory care ward (RCW) in northern Taiwan. They were randomly assigned to the experimental group and the control group. The experimental group was given 45 degree Semi-sitting 2hrs and upper-limb exercise training 10mins once a day. After 4 weeks, the investigators measure the respiratory parameters such as the maximum inspiratory pressure (MIP), the tidal volume (VT), the minute ventilation (MV), and the rapid shallow breathing index(RSBI) of these two groups, and used the generalized estimating equation (GEE) to compare with them.

Official Title
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The Effect of 45 Degree Semi-recumbent Position With Upper Limb Exercise Training on Long-term Ventilator-dependent Patients

Conditions
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Mechanical Ventilation, Difficult Intubation, Position, Exercise

Intervention / Treatment
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* Behavioral: 45 Degree Semi-recumbent Position With Upper Limb Exercise Training
* Behavioral: no 45 Degree Semi-recumbent Position With Upper Limb Exercise Training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria respiratory care ward (RCW) cases using mechanical ventilators 20 years old ≦ age ≦ 89 years old Those who used antibiotics without infection and fever (body temperature >38.5℃) in the past 3 days the fraction of inspiration O2(FiO2)≦50% and the positive end expiratory pressure(PEEP)≦10 90 mm-Hg≦ systolic blood pressure(SBP) ≦160 mm-Hg 60 beats/min≦ heart rate(HR) ≦130 beats/min without arrhythmia 12 times/min≦ respiratory rate(RR) ≦35 times/min 90%≦ oxygen saturation by pulse oximetry (SPO2) ≦100% Patients with spontaneous breathing Digestible without continuous feeder Exclusion Criteria: respiratory care ward (RCW) cases without mechanical ventilators Age <20 years old or age>89 years old Those who have been infected with fever in the past 3 days (body temperature >38.5℃) and are taking antibiotic the fraction of inspiration O2(FiO2) >50% and the positive end expiratory pressure(PEEP)>10 systolic blood pressure(SBP)< 90 mm-Hg or systolic blood pressure(SBP) >160 mm-Hg heart rate(HR)<60 beats/min or heart rate(HR)>130 beats/min and arrhythmia respiratory rate(RR)<12 times/minute or respiratory rate(RR)>35 times/minute oxygen saturation by pulse oximetry (SPO2) <90% Patients without spontaneous breathing Poor digestion and use of continuous feeders

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 89 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This study used repeated experimental measurements and purpose sampling, and we invited patients in respiratory care ward (RCW) in northern Taiwan. They were randomly assigned to the experimental group and the control group. The experimental group was given 45 degree Semi-sitting for 2hrs and upper-limb exercise training 10mins once a day. The control group was just continue the routine treatment. After 4 weeks, we measure the respiratory parameters such as maximum inspiratory pressure (MIP), tidal volume (VT), minute ventilation (MV), and rapid shallow breathing index(RSBI) of these two groups, and used GEE to compare with them. To find the differences in respiratory parameters, ventilator detachment rate,
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Long-term Ventilator-dependent Patients with intervention<br>45 Degree Semi-recumbent Position With Upper Limb Exercise Training on Long-term Ventilator-dependent Patients | Behavioral: 45 Degree Semi-recumbent Position With Upper Limb Exercise Training<br>* The experimental group was given 45 degree Semi-sitting 2 hrs and upper-limb exercise training 10 mins once a day, and this intervention kept 4 weeks.<br>* Other names: 45 Degree Semi-sitting Position With Upper Limb Exercise Training;|
| Experimental: Long-term Ventilator-dependent Patients without intervention<br>There is no intervention on Long-term Ventilator-dependent Patients ,and just keep routine treatment. | Behavioral: no 45 Degree Semi-recumbent Position With Upper Limb Exercise Training<br>* The control group was with usual treatment.<br>* Other names: no other intervention;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| maximum inspiratory pressure (MIP) | After doing intervention for 4 weeks, we measure the maximum inspiratory pressure (MIP) of these two groups | Change from maximum inspiratory pressure (MIP) at 1 month | 
| tidal volume (VT) | After doing intervention for 4 weeks, we measure the tidal volume (VT) of these two groups | Change from tidal volume (VT) at 1 month | 
| minute ventilation (MV) | After doing intervention for 4 weeks, we measure the minute ventilation (MV) of these two groups | Change from minute ventilation (MV) at 1 month | 
| rapid shallow breathing index (RSBI) | After doing intervention for 4 weeks, we measure the rapid shallow breathing index (RSBI) of these two groups | Change from rapid shallow breathing index (RSBI) at 1 month |