Clinical trial NCT04822831: The Effect of Semi-recumbent Position With Exercise Training on Long-term Ventilator-dependent Patients
Official title: The Effect of 45 Degree Semi-recumbent Position With Upper Limb Exercise Training on Long-term Ventilator-dependent Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mechanical Ventilation
Difficult Intubation
Position
Exercise
Lead sponsor: Taoyuan General Hospital
Sponsor class: OTHER_GOV
First posted: 2021-03-30
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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,
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: maximum inspiratory pressure (MIP)
timeFrame: Change from maximum inspiratory pressure (MIP) at 1 month
measure: tidal volume (VT)
timeFrame: Change from tidal volume (VT) at 1 month
measure: minute ventilation (MV)
timeFrame: Change from minute ventilation (MV) at 1 month
measure: rapid shallow breathing index (RSBI)
timeFrame: Change from rapid shallow breathing index (RSBI) at 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Taoyuan
country: Taiwan
facility: Se-Hua Lin
state: Longtan Dist.
Study officials:
affiliation: Taoyuan Armed Forces General Hospital
name: Se-Hua Lin, master
role: PRINCIPAL_INVESTIGATOR
References: