Prolonged Weaning, Early Mobilization, Chest PhysiotherapyNCT06095609
The Implementation of Early Mobilization and Chest Physiotherapy on Weaning Rate of Prolong Weaning Patients.
A study testing Early mobilization plus chest physiotherapy in people with Prolonged Weaning, Early Mobilization, Chest Physiotherapy, run by Taoyuan General Hospital at 1 site in Taiwan.
Trial summary
Weaning from mechanical ventilator is essential to liberate patients to normal life. Prolong weaning is defined as failure of 3 times spontaneous breath trial (SBT) and requiring more than 7 days weaning from mechanical ventilation after first SBT. higher unsuccessful rate of extubation and higher mortality rate. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Prolonged Weaning, Early Mobilization, Chest Physiotherapy
- What is being tested?
- Early mobilization plus chest physiotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 202 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jun 2022to 19 Jun 2022
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The subjects' data which met the inclusion criteria are: 1. Age>20 2. Patient with or without 3. Patient who met the criteria of received physiotherapy (Figure 1.) 4. No usage of life support device such as ECMO and so on. 5. Continuous mechanical ventilator use over 21 days.
Who cannot join
- The exclusion criteria are 1. Patients diagnosed as brain death 2. Patients who were ventilator dependent before admission 3. Patients who were against advice discharge under critical condition. 4. Patients received emergency intervention during course. 5. Patient who didn't meet the criteria of received physiotherapy (Figure 1.).
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Taoyaun General Hospital, Ministry of Wealth and Health
Taoyuan, Taoyuan Dist., 330
About this study
Official title: The Implementation of Early Mobilization and Chest Physiotherapy on Weaning Rate of Prolong Weaning Patients. A Retrospective Study
Weaning from mechanical ventilator is essential to liberate patients to normal life. Prolong weaning is defined as failure of 3 times spontaneous breath trial (SBT) and requiring more than 7 days weaning from mechanical ventilation after first SBT. higher unsuccessful rate of extubation and higher mortality rate. Possible reasons to cause prolong weaning could be attributed to intensive care unit acquired weakness (ICU-AW) and poor lung hygiene. In order to solve these two problems and increase the weaning rate, early mobilization (EM) and chest physiotherapy (CPT) are considered as possible strategy to attain the goal. According to previous articles, lacking of control group and small sample size made it difficult to confirm the true effect of EM and CPT on prolong weaning patients. Thus, the aims of this articles are discussing the influence from EM with CPT on weaning rate and other hospitalization outcomes with larger sample sizes and control group.
- Being tested
- Early mobilization plus chest physiotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early mobilization plus chest physiotherapyOther
Early mobilization:early mobilization has been confirmed its positive effectiveness on cutting down the MV use days and mortality rate, attenuating the side effect such as muscle strength loss and functional activity dysfunction resulting from ICU acquired weakness among the patients with mechanical ventilation.
Chest physiotherapy:a common technique to reduce the respiratory complications in ICU, has been proved certain positive influence on airway clearance and hospital lengths of stay.
| Study group | Role | What they receive |
|---|---|---|
| Early mobilization plus chest physiotherapy | Experimental | Physiotherapy program comprised two parts early mobilization and CPT. They could be divided into different levels depended on patients' ability. In terms of the levels of early mobilization, first level was defined as patients who could only receive passive patterns of exercise. Second level would be executed to patient who could only take exercise on the bed or with back support. Third level would be implemented when patients could advance to receive physiotherapy beside the bed without support. The eventual level would be conducted when patients was able to leave beds by their own. In line with chest physiotherapy, level I was defined as patients who could only receive passive lung hygiene protocol. Level II would be executed when patient can control their breath and cough by their own. Level III would be implemented when patient can maintain their body steadily and finish the chest physiotherapy protocol. Receives: Other: Early mobilization plus chest physiotherapy |
| Routine care | No intervention | no physiotherapy involved |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weaning success rate
Weaning success was defined as patients being free from MV or BiPAP for 5 days based on Taiwan
Measured: up to 6 weeks in respiratory care center
Secondary outcomes (6)
RCC mortality rate
the mortality rate of respiratory care center
Measured: up to 6 weeks in respiratory care center
hospital mortality rate
the mortality rate during the hospital course
Measured: up to 6 weeks in respiratory care center
discharge to home rate
The rate of going home after discharge
Measured: after 6 weeks in respiratory care center
total mechanical ventilator use
The days of mechanical use during the admission time
Measured: up to 6 weeks in respiratory care center
RCC days of stay
The days staying in respiratory care center
Measured: up to 6 weeks in respiratory care center
total hospital days of stay
The days staying in the hospital
Measured: up to 10 weeks in the hospital
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2023
- Study start1 Jun 2022
- Primary completion18 Jun 2022
- Study completion19 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prolonged Weaning, Early Mobilization, Chest PhysiotherapyStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- The study retrospectively reviewed the medical record from the medical team. Patients before 2019/01/01 who didn't receive physiotherapy are regarded as control group. Patients after 2019/01/01 are assigned to the experiment group.
- Masking
- None (open label)
- Enrolment
- 202 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taoyuan General Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06095609
- Sponsor's protocol ID
- TYGH111002
- Status last verified
- Sep 2022
- First submitted
- 20 Jun 2022
- Last updated
- 23 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Implementation of Early Mobilization and Chest Physiotherapy on Weaning Rate of Prolong Weaning Patients. A Retrospective Study
- ClinicalTrials.gov ID
- NCT06095609
- Acronym / sponsor ID
- TYGH111002
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 202 participants (actual)
- Lead sponsor
- Taoyuan General HospitalOther government
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 18 Jun 2022 (actual)
- Study completion
- 19 Jun 2022 (actual)
- First posted
- 23 Oct 2023 (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.
Weaning from mechanical ventilator is essential to liberate patients to normal life. Prolong weaning is defined as failure of 3 times spontaneous breath trial (SBT) and requiring more than 7 days weaning from mechanical ventilation after first SBT. higher unsuccessful rate of extubation and higher mortality rate. Possible reasons to cause prolong weaning could be attributed to intensive care unit acquired weakness (ICU-AW) and poor lung hygiene. In order to solve these two problems and increase the weaning rate, early mobilization (EM) and chest physiotherapy (CPT) are considered as possible strategy to attain the goal. According to previous articles, lacking of control group and small sample size made it difficult to confirm the true effect of EM and CPT on prolong weaning patients. Thus, the aims of this articles are discussing the influence from EM with CPT on weaning rate and other hospitalization outcomes with larger sample sizes and control group.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study retrospectively reviewed the medical record from the medical team. Patients before 2019/01/01 who didn't receive physiotherapy are regarded as control group. Patients after 2019/01/01 are assigned to the experiment group.
| Arm | Type | Receives |
|---|---|---|
| Early mobilization plus chest physiotherapy | Experimental | Other: Early mobilization plus chest physiotherapyPhysiotherapy program comprised two parts early mobilization and CPT. They could be divided into different levels depended on patients' ability. In terms of the levels of early mobilization, first level was defined as patients who could only receive passive patterns of exercise. Second level would be executed to patient who could only take exercise on the bed or with back support. Third level would be implemented when patients could advance to receive physiotherapy beside the bed without support. The eventual level would be conducted when patients was able to leave beds by their own. In line with chest physiotherapy, level I was defined as patients who could only receive passive lung hygiene protocol. Level II would be executed when patient can control their breath and cough by their own. Level III would be implemented when patient can maintain their body steadily and finish the chest physiotherapy protocol. |
| Routine care | No intervention | –no physiotherapy involved |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- The subjects' data which met the inclusion criteria are: 1. Age>20 2. Patient with or without 3. Patient who met the criteria of received physiotherapy (Figure 1.) 4. No usage of life support device such as ECMO and so on. 5. Continuous mechanical ventilator use over 21 days.
Key exclusion criteria (1 listed)
- The exclusion criteria are 1. Patients diagnosed as brain death 2. Patients who were ventilator dependent before admission 3. Patients who were against advice discharge under critical condition. 4. Patients received emergency intervention during course. 5. Patient who didn't meet the criteria of received physiotherapy (Figure 1.).
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 |
|---|---|---|
| Early mobilization plus chest physiotherapyEarly mobilization:early mobilization has been confirmed its positive effectiveness on cutting down the MV use days and mortality rate, attenuating the side effect such as muscle strength loss and functional activity dysfunction resulting from ICU acquired weakness among the patients with mechanical ventilation. Chest physiotherapy:a common technique to reduce the respiratory complications in ICU, has been proved certain positive influence on airway clearance and hospital lengths of stay. | Other | Early mobilization plus chest physiotherapy |
Primary outcome
Weaning success rate
Time frame: up to 6 weeks in respiratory care center
Weaning success was defined as patients being free from MV or BiPAP for 5 days based on Taiwan
6 secondary outcomes
RCC mortality rate
Time frame: up to 6 weeks in respiratory care center
hospital mortality rate
Time frame: up to 6 weeks in respiratory care center
discharge to home rate
Time frame: after 6 weeks in respiratory care center
total mechanical ventilator use
Time frame: up to 6 weeks in respiratory care center
RCC days of stay
Time frame: up to 6 weeks in respiratory care center
total hospital days of stay
Time frame: up to 10 weeks in the hospital
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 23 Oct 2023.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early mobilization plus chest physiotherapy in people with Prolonged Weaning, Early Mobilization, Chest Physiotherapy, 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 1 inclusion and 1 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 23 Oct 2023. 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?
Weaning success rate (time frame: up to 6 weeks in respiratory care center). 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 23 Oct 2023.