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Completed

NCT Number: NCT04822831

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

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.

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Key information

Age range

20 year–89 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Se-Hua Lin

Taoyuan, Longtan Dist., 325, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: 45 Degree Semi-sitting Position With Upper Limb Exercise Training

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

Behavioral

The control group was with usual treatment.

Other names: no other intervention

Primary outcomes

  1. maximum inspiratory pressure (MIP)

    Time frame: Change from maximum inspiratory pressure (MIP) at 1 month

    After doing intervention for 4 weeks, we measure the maximum inspiratory pressure (MIP) of these two groups

  2. tidal volume (VT)

    Time frame: Change from tidal volume (VT) at 1 month

    After doing intervention for 4 weeks, we measure the tidal volume (VT) of these two groups

  3. minute ventilation (MV)

    Time frame: Change from minute ventilation (MV) at 1 month

    After doing intervention for 4 weeks, we measure the minute ventilation (MV) of these two groups

  4. rapid shallow breathing index (RSBI)

    Time frame: Change from rapid shallow breathing index (RSBI) at 1 month

    After doing intervention for 4 weeks, we measure the rapid shallow breathing index (RSBI) of these two groups

Sponsors and collaborators

Lead sponsor

Taoyuan General Hospital

Other Gov

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Mar 30, 2021
Registry last updated
Apr 1, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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