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Short Effects of SIMT and EM in Prolonged Mechanically Ventilated Patients

Short Effects of Speci|c Inspiratory Muscle Training and Early Mobilization in Prolonged Mechanically Ventilated Patients

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06368089
Enrollment
46
Registered
2024-04-16
Start date
2024-05-06
Completion date
2026-03-31
Last updated
2024-11-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ventilator Dependent

Keywords

Specific inspiratory muscle training, Early mobilization, Lung compliance, Prolong mechanical ventilation, Weaning outcome

Brief 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. 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. 2. 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.

Interventions

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.

OTHEREarly mobilization (EM) group

The ER group received active exercise in sitting, standing, and marching 30 minutes/day for 7 days with conventional chest physical therapy

Sponsors

Prince of Songkla University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

randomization

Eligibility

Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* 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. * 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.

Design outcomes

Primary

MeasureTime frameDescription
Maximum inspiratory pressure (MIP)baseline and day 7 after programMIP 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)baseline and day 7 after programDynamic 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

Secondary

MeasureTime frameDescription
Weaning timebaseline and day 7 after programDuration of weaning time (hour)
Weaning outcomebaseline and day 7 after programmeasure weaning success rate
Grip strengthbaseline and day 7 after programusing hand grip dynamometer
chest wall expansionbaseline and day 7 after programmeasure by using tape at the axillary, xiphoid process, and umbrilical level

Countries

Thailand

Contacts

Primary ContactSaikaew Chuachan, Msc.PT
saikaew.ch@psu.ac.th0849988665

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026