Mechanical VentilationNCT04822831
The Effect of Semi-recumbent Position With Exercise Training on Long-term Ventilator-dependent Patients
A study testing 45 Degree Semi-recumbent Position With Upper Limb Exercise Training and no 45 Degree Semi-recumbent Position With Upper Limb Exercise Training in people with Mechanical Ventilation and Difficult Intubation, run by Taoyuan General Hospital at 1 site in Taiwan.
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). Read more about this study
- Who is it for?
- Ages 20 to 89 years
- Conditions the study is for
- Mechanical Ventilation, Difficult Intubation, Position
- What is being tested?
- 45 Degree Semi-recumbent Position With Upper Limb Exercise Training and no 45 Degree Semi-recumbent Position With Upper Limb Exercise Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- 30 May 2017to 30 Jul 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of 45 Degree Semi-recumbent Position With Upper Limb 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.
Read the 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
- Being tested
- 45 Degree Semi-recumbent Position With Upper Limb Exercise Training, no 45 Degree Semi-recumbent Position With Upper Limb Exercise Training
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
45 Degree Semi-recumbent Position With Upper Limb Exercise TrainingBehavioural
Also called 45 Degree Semi-sitting 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 TrainingBehavioural
Also called no other intervention
The control group was with usual treatment.
| Study group | Role | What they receive |
|---|---|---|
| Long-term Ventilator-dependent Patients with intervention | Experimental | 45 Degree Semi-recumbent Position With Upper Limb Exercise Training on Long-term Ventilator-dependent Patients Receives: 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. Receives: Behavioral: no 45 Degree Semi-recumbent Position With Upper Limb Exercise Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
maximum inspiratory pressure (MIP)
After doing intervention for 4 weeks, we measure the maximum inspiratory pressure (MIP) of these two groups
Measured: 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
Measured: 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
Measured: 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
Measured: Change from rapid shallow breathing index (RSBI) at 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2021
- Study start30 May 2017
- Primary completion30 May 2018
- Study completion30 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mechanical VentilationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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,
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taoyuan General Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Se-Hua Lin, Taoyuan General Hospital
- Investigators
- Se-Hua Lin, master, Principal investigator, Taoyuan Armed Forces General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04822831
- Sponsor's protocol ID
- SeHLin
- Status last verified
- Mar 2021
- First submitted
- 23 Mar 2021
- Last updated
- 1 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: we don't plan to make individual participant data (IPD) ,because the database belonged to patients and hospitals
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of 45 Degree Semi-recumbent Position With Upper Limb Exercise Training on Long-term Ventilator-dependent Patients
- ClinicalTrials.gov ID
- NCT04822831
- Acronym / sponsor ID
- SeHLin
- Conditions
- Mechanical Ventilation, Difficult Intubation, Position, Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Taoyuan General HospitalOther government
- Study start
- 30 May 2017 (actual)
- Primary completion
- 30 May 2018 (actual)
- Study completion
- 30 Jul 2018 (actual)
- First posted
- 30 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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,
| Arm | Type | Receives |
|---|---|---|
| Long-term Ventilator-dependent Patients with intervention | Experimental | Behavioral: 45 Degree Semi-recumbent Position With Upper Limb Exercise Training45 Degree Semi-recumbent Position With Upper Limb Exercise Training on Long-term Ventilator-dependent Patients |
| Long-term Ventilator-dependent Patients without intervention | Experimental | Behavioral: no 45 Degree Semi-recumbent Position With Upper Limb Exercise TrainingThere is no intervention on Long-term Ventilator-dependent Patients ,and just keep routine treatment. |
Who may qualify
- Ages
- 20 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 45 Degree Semi-recumbent Position With Upper Limb Exercise TrainingAlso: 45 Degree Semi-sitting Position With Upper Limb Exercise TrainingThe 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. | Behavioural | Long-term Ventilator-dependent Patients with intervention |
| no 45 Degree Semi-recumbent Position With Upper Limb Exercise TrainingAlso: no other interventionThe control group was with usual treatment. | Behavioural | Long-term Ventilator-dependent Patients without intervention |
Primary outcome
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2021.
- Individual participant dataSharing planned: No. we don't plan to make individual participant data (IPD) ,because the database belonged to patients and hospitals
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Se-Hua Lin, master principal investigator
Taoyuan Armed Forces General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 45 Degree Semi-recumbent Position With Upper Limb Exercise Training and no 45 Degree Semi-recumbent Position With Upper Limb Exercise Training in people with Mechanical Ventilation and Difficult Intubation, run by Taoyuan General Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
maximum inspiratory pressure (MIP) (time frame: Change from maximum inspiratory pressure (MIP) at 1 month). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2021.