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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04822831
Other study ID # SeHLin
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 30, 2017
Est. completion date July 30, 2018

Study information

Verified date March 2021
Source Taoyuan General Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date July 30, 2018
Est. primary completion date May 30, 2018
Accepts healthy volunteers No
Gender All
Age group 20 Years to 89 Years
Eligibility 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

Study Design


Intervention

Behavioral:
45 Degree Semi-recumbent Position With Upper Limb Exercise Training
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.
no 45 Degree Semi-recumbent Position With Upper Limb Exercise Training
The control group was with usual treatment.

Locations

Country Name City State
Taiwan Se-Hua Lin Taoyuan Longtan Dist.

Sponsors (1)

Lead Sponsor Collaborator
Taoyuan General Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
Primary 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
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