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

NCT04822831 | Completed DMC

• 1 other identifier: SeHLin
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Mechanical Ventilation; Difficult Intubation; Position; Exercise

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (2)

Long-term Ventilator-dependent Patients with intervention

EXPERIMENTAL

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

Long-term Ventilator-dependent Patients without intervention

EXPERIMENTAL

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

Interventions

45 Degree Semi-recumbent Position With Upper Limb Exercise Training 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.

Also known as: 45 Degree Semi-sitting Position With Upper Limb Exercise Training

Long-term Ventilator-dependent Patients with intervention

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

The control group was with usual treatment.

Also known as: no other intervention

Long-term Ventilator-dependent Patients without intervention

Eligibility Criteria

• Age: 20 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• respiratory care ward (RCW) cases using mechanical ventilators
• 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
• mm-Hg≦ systolic blood pressure(SBP) ≦160 mm-Hg
• beats/min≦ heart rate(HR) ≦130 beats/min without arrhythmia
• times/min≦ respiratory rate(RR) ≦35 times/min
• %≦ oxygen saturation by pulse oximetry (SPO2) ≦100%
• Patients with spontaneous breathing
• Digestible without continuous feeder

You may not qualify if:

• 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

Sponsors & Collaborators

• Taoyuan General Hospital: lead

Study Sites (1)

Se-Hua Lin

Taoyuan District, Longtan Dist., 325, Taiwan

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Se-Hua Lin, master

  Taoyuan Armed Forces General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The participants involved in the clinical trial who are prevented from having knowledge of the interventions assigned to individual participants.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head Nurse

Model Details: 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,

Study Record Dates

• First Submitted: March 23, 2021
• First Posted: March 30, 2021
• Study Start: May 30, 2017
• Primary Completion: May 30, 2018
• Study Completion: July 30, 2018
• Last Updated: April 1, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)