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

NCT ID: NCT04822831

Last Updated: 2021-04-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-05-30
• Study Completion Date: 2018-07-30

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.

Conditions

Mechanical Ventilation; Difficult Intubation; Position; Exercise

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Long-term Ventilator-dependent Patients with intervention

45 Degree Semi-recumbent Position With Upper Limb Exercise Training on Long-term Ventilator-dependent Patients

Group Type: EXPERIMENTAL

45 Degree Semi-recumbent Position With Upper Limb Exercise Training

Intervention Type: BEHAVIORAL

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.

Long-term Ventilator-dependent Patients without intervention

There is no intervention on Long-term Ventilator-dependent Patients ,and just keep routine treatment.

Group Type: EXPERIMENTAL

no 45 Degree Semi-recumbent Position With Upper Limb Exercise Training

Intervention Type: BEHAVIORAL

The control group was with usual treatment.

Interventions

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.

Intervention Type: BEHAVIORAL

no 45 Degree Semi-recumbent Position With Upper Limb Exercise Training

The control group was with usual treatment.

Intervention Type: BEHAVIORAL

Other Intervention Names

45 Degree Semi-sitting Position With Upper Limb Exercise Training; no other intervention

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 89 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Taoyuan General Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Se-Hua Lin

Head Nurse

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Se-Hua Lin, master

Role: PRINCIPAL_INVESTIGATOR

Taoyuan Armed Forces General Hospital

Locations

Se-Hua Lin

Taoyuan District, Longtan Dist., Taiwan

Countries

Taiwan

Other Identifiers

SeHLin

Identifier Type: -

Identifier Source: org_study_id