Ventilator DependentNCT06368089
Short Effects of SIMT and EM in Prolonged Mechanically Ventilated Patients
A study testing Inspiratory muscle training (IMT) group and Early mobilization (EM) group in people with Ventilator Dependent, run by Prince of Songkla University at 1 site in Thailand.
Trial summary
Using mechanical ventilation for more than 18 hours can affect respiratory muscle and postural muscle control, making it difficult to wean off the ventilator and reducing mobility. The aim of this study is to: 1. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Ventilator Dependent
- What is being tested?
- Inspiratory muscle training (IMT) group and Early mobilization (EM) group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteThailand
- Study dates
- 6 May 2024to Mar 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with respiratory diseases who have been on mechanical ventilation for more than 48 hours and are ready to be weaned off or undergoing weaning trials with continuous positive airway pressure (CPAP) or synchronized intermittent mandatory ventilation (SIMV).
- The PaO2/FiO2 ratio is ≥ 150-200, with FiO2 ≤ 0.4-0.5 and PEEP ≤ 5-8 cmH2O, and a pH \> 7.3 in blood plasma.
- The age range is between 40 and 80 years old.
- Patients exhibit good self-awareness and cooperation in training (Riker score of 4).
- They can understand and communicate in Thai
Who cannot join
- Clinical instability (HR \> 120 beats/minute, RR \> 30 breaths/minute, SatO2 \< 90%, SBP \> 140 mmHg or \< 90 mmHg)
- Patients who can be extubated and use non-invasive ventilation only or successfully extubated within the first 24 hours.
- Patients with altered mental status (Glasgow Coma Score \< 10) and inability to cooperate with training (Riker score \< 4 or \> 4)
- Patients with limitations or contraindications such as inability to adjust the bed to a 45-degree angle or sit on the side of the bed, such as those with spinal cord injuries or recent head surgeries.
- History of hemoptysis, pneumothorax
- History of neuromuscular diseases causing muscle weakness and decreased sensation.
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- Patients with excessive cardiac stimulation (\> 5 micrograms per kilogram per minute)
- Heart rate \> 140 beats per minute
- Hemoglobin levels \< 8-10 grams per deciliter
- Patients with difficult airway issues.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Thailand1 site, 1 recruiting
- Recruiting
Medical Respiratory Care Unit (MRCU), Prince of Songklanakarind Hospital
Songkhla, 90110
About this study
Official title: Short Effects of Speci|c Inspiratory Muscle Training and Early Mobilization in Prolonged Mechanically Ventilated Patients
Using mechanical ventilation for more than 18 hours can affect respiratory muscle and postural muscle control, making it difficult to wean off the ventilator and reducing mobility. The aim of this study is to:
- Compare the effects of respiratory muscle strength training and early mobilization on dynamic lung compliance and maximum inspiratory pressure before and after a 7-day training period.
- Compare the success rate of weaning and the duration of weaning between the respiratory muscle strength training and the early mobilization program.
Read the detailed description
The prolonged mechanical ventilation results in difficulty weaning off the ventilator. Inspiratory muscle strength and early mobilization can contribute to the expansion of lung parenchyma and facilitate success in weaning off respiratory support. Thus, this study aimed to explain the impact of inspiratory muscle training and early mobilization on dynamic lung compliance, spontaneous breathing time, and success rate in patients who have undergone mechanical ventilation for more than 48 hours.
- Conditions
- Ventilator Dependent
- Being tested
- Inspiratory muscle training (IMT) group, Early mobilization (EM) group
- Keywords
- Specific inspiratory muscle training, Early mobilization, Lung compliance, Prolong mechanical ventilation, Weaning outcome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inspiratory muscle training (IMT) groupOther
The IMT group receives inspiratory muscle training of 50%MIP, 6 breaths/set 10 sets/day for 7 days combined with conventional chest physiotherapy including; percussion, vibration, postural draining, positioning, and passive range of motion.
Early mobilization (EM) groupOther
The ER group received active exercise in sitting, standing, and marching 30 minutes/day for 7 days with conventional chest physical therapy
| Study group | Role | What they receive |
|---|---|---|
| IMT group | Experimental | Inspiratory muscle training group Receives: Other: Inspiratory muscle training (IMT) group |
| EM group | Active comparator | Early mobilization group Receives: Other: Early mobilization (EM) group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum inspiratory pressure (MIP)
MIP measurement using manometer, the device can be attached directly to the ETT or tracheostomy tube, and measures the pressure generated by patient on inhalation against a closed system.
Measured: baseline and day 7 after program
Dynamic lung compliance (Cdyn)
Dynamic lung compliance refers to the ratio of the change in volume to the change in pressure over a tidal breath, with the pressure measured at moments of zero flow during breathing that recording from the mechanical ventilation
Measured: baseline and day 7 after program
Secondary outcomes (4)
Weaning time
Duration of weaning time (hour)
Measured: baseline and day 7 after program
Weaning outcome
measure weaning success rate
Measured: baseline and day 7 after program
Grip strength
using hand grip dynamometer
Measured: baseline and day 7 after program
chest wall expansion
measure by using tape at the axillary, xiphoid process, and umbrilical level
Measured: baseline and day 7 after program
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2024
- Study start6 May 2024
- Primary completionFeb 2026 (estimated)
- Study completionMar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventilator DependentStudies 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
- randomization
- Masking
- None (open label)
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Prince of Songkla University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Saikaew Chuachan, Prince of Songkla University
- Investigators
- Saikaew Chuachan, Principal investigator, Department of Physical Therapy, Faculty of Medicine, PSUNatcha Kimthiaw, Bsc.PT, Study director, Department of Physical Therapy, Faculty of Medicine, PSULuksamee Kaewchano, Bsc.PT, Study director, Department of Physical Therapy, Faculty of Medicine, PSUIttiphon Pannarai, Bsc.PT, Study director, Department of Physical Therapy, Faculty of Medicine, PSUJatuporn Jaturawanit, Bsc.PT, Study director, Physical Therapy unit, Songklanakarind HospitalJitsupa Kittarakul, Bsc.PT, Study director, Physical Therapy unit, Songklanakarind HospitalBoonmas Chansirimongkol, B.N.S., Study director, Medical Respiratory Care Unit, Prince of Songklanakarind HospitalKwankamol Kalsri, B.N.S, Study director, Medical Respiratory Care Unit, Prince of Songklanakarind Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06368089
- Sponsor's protocol ID
- REC.66-474-30-2
- Other IDs
- MR-PSU:66-30-21-406
- Status last verified
- Nov 2024
- First submitted
- 1 Apr 2024
- Last updated
- 6 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short Effects of Speci|c Inspiratory Muscle Training and Early Mobilization in Prolonged Mechanically Ventilated Patients
- ClinicalTrials.gov ID
- NCT06368089
- Acronym / sponsor ID
- REC.66-474-30-2
- Conditions
- Ventilator Dependent
- Keywords
- Specific inspiratory muscle training, Early mobilization, Lung compliance, Prolong mechanical ventilation, Weaning outcome
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Prince of Songkla UniversityUniversity, hospital or other
- Study start
- 6 May 2024 (actual)
- Primary completion
- Feb 2026 (estimated)
- Study completion
- Mar 2026 (estimated)
- First posted
- 16 Apr 2024 (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.
Using mechanical ventilation for more than 18 hours can affect respiratory muscle and postural muscle control, making it difficult to wean off the ventilator and reducing mobility. The aim of this study is to:
- Compare the effects of respiratory muscle strength training and early mobilization on dynamic lung compliance and maximum inspiratory pressure before and after a 7-day training period.
- Compare the success rate of weaning and the duration of weaning between the respiratory muscle strength training and the early mobilization program.
Detailed description
The prolonged mechanical ventilation results in difficulty weaning off the ventilator. Inspiratory muscle strength and early mobilization can contribute to the expansion of lung parenchyma and facilitate success in weaning off respiratory support. Thus, this study aimed to explain the impact of inspiratory muscle training and early mobilization on dynamic lung compliance, spontaneous breathing time, and success rate in patients who have undergone mechanical ventilation for more than 48 hours.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- randomization
| Arm | Type | Receives |
|---|---|---|
| IMT group | Experimental | Other: Inspiratory muscle training (IMT) groupInspiratory muscle training group |
| EM group | Active comparator | Other: Early mobilization (EM) groupEarly mobilization group |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with respiratory diseases who have been on mechanical ventilation for more than 48 hours and are ready to be weaned off or undergoing weaning trials with continuous positive airway pressure (CPAP) or synchronized intermittent mandatory ventilation (SIMV).
- The PaO2/FiO2 ratio is ≥ 150-200, with FiO2 ≤ 0.4-0.5 and PEEP ≤ 5-8 cmH2O, and a pH \> 7.3 in blood plasma.
- The age range is between 40 and 80 years old.
- Patients exhibit good self-awareness and cooperation in training (Riker score of 4).
- They can understand and communicate in Thai
Key exclusion criteria (10 listed)
- Clinical instability (HR \> 120 beats/minute, RR \> 30 breaths/minute, SatO2 \< 90%, SBP \> 140 mmHg or \< 90 mmHg)
- Patients who can be extubated and use non-invasive ventilation only or successfully extubated within the first 24 hours.
- Patients with altered mental status (Glasgow Coma Score \< 10) and inability to cooperate with training (Riker score \< 4 or \> 4)
- Patients with limitations or contraindications such as inability to adjust the bed to a 45-degree angle or sit on the side of the bed, such as those with spinal cord injuries or recent head surgeries.
- History of hemoptysis, pneumothorax
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 |
|---|---|---|
| Inspiratory muscle training (IMT) groupThe IMT group receives inspiratory muscle training of 50%MIP, 6 breaths/set 10 sets/day for 7 days combined with conventional chest physiotherapy including; percussion, vibration, postural draining, positioning, and passive range of motion. | Other | IMT group |
| Early mobilization (EM) groupThe ER group received active exercise in sitting, standing, and marching 30 minutes/day for 7 days with conventional chest physical therapy | Other | EM group |
Primary outcome
Maximum inspiratory pressure (MIP)
Time frame: baseline and day 7 after program
MIP measurement using manometer, the device can be attached directly to the ETT or tracheostomy tube, and measures the pressure generated by patient on inhalation against a closed system.
Dynamic lung compliance (Cdyn)
Time frame: baseline and day 7 after program
Dynamic lung compliance refers to the ratio of the change in volume to the change in pressure over a tidal breath, with the pressure measured at moments of zero flow during breathing that recording from the mechanical ventilation
4 secondary outcomes
Weaning time
Time frame: baseline and day 7 after program
Weaning outcome
Time frame: baseline and day 7 after program
Grip strength
Time frame: baseline and day 7 after program
chest wall expansion
Time frame: baseline and day 7 after program
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2024.
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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.
Saikaew Chuachan principal investigator
Department of Physical Therapy, Faculty of Medicine, PSU
Natcha Kimthiaw, Bsc.PT study director
Department of Physical Therapy, Faculty of Medicine, PSU
Luksamee Kaewchano, Bsc.PT study director
Department of Physical Therapy, Faculty of Medicine, PSU
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Inspiratory muscle training (IMT) group and Early mobilization (EM) group in people with Ventilator Dependent, run by Prince of Songkla University at 1 site in Thailand.
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 5 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: looking for participants now, as of the sponsor's last update on 6 Nov 2024. 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 Thailand. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Saikaew Chuachan, Msc.PT (0849988665, saikaew.ch@psu.ac.th), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum inspiratory pressure (MIP) (time frame: baseline and day 7 after program). The study lists 2 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 6 Nov 2024.