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Search / Trial NCT06368089

Short Effects of SIMT and EM in Prolonged Mechanically Ventilated Patients

Launched by PRINCE OF SONGKLA UNIVERSITY · Apr 15, 2024

Trial Information

Current as of August 22, 2025

Recruiting

Keywords

Specific Inspiratory Muscle Training Early Mobilization Lung Compliance Prolong Mechanical Ventilation Weaning Outcome

ClinConnect Summary

This clinical trial is looking at how two different therapies can help patients who have been on a ventilator for a long time. When patients are on mechanical ventilation for more than 18 hours, it can weaken their breathing and movement muscles, making it harder for them to breathe on their own again. The study will compare respiratory muscle strength training—which focuses on improving the strength of the muscles used for breathing—and early mobilization, which encourages patients to start moving around again. Researchers want to see which method better helps patients improve their lung function and makes it easier for them to stop using the ventilator.

To take part in this trial, patients need to be between 40 and 80 years old, have been on a ventilator for at least 48 hours, and be ready to try to breathe without it. They also need to be able to understand and follow directions in Thai. However, patients who are very unstable or have certain health issues, like severe heart problems or muscle diseases, may not be eligible. Participants can expect to engage in either breathing exercises or mobility activities over a week, with the goal of improving their chances of successfully weaning off the ventilator. This trial is currently recruiting participants, and it aims to find ways to help improve recovery for ventilator-dependent patients.

Gender

ALL

Eligibility criteria

  • 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.

About Prince Of Songkla University

Prince of Songkla University (PSU) is a prestigious academic institution located in Thailand, renowned for its commitment to advancing medical research and education. As a clinical trial sponsor, PSU leverages its extensive resources and expertise to conduct innovative research that addresses critical health challenges. The university fosters collaboration among multidisciplinary teams of researchers, healthcare professionals, and students, ensuring rigorous study designs and adherence to ethical standards. PSU's dedication to improving public health outcomes is reflected in its focus on translating research findings into practical applications that benefit local and global communities.

Locations

Songkhla, , Thailand

Patients applied

0 patients applied

Trial Officials

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

Ittiphon Pannarai, Bsc.PT

Study Director

Department of Physical Therapy, Faculty of Medicine, PSU

Jatuporn Jaturawanit, Bsc.PT

Study Director

Physical Therapy unit, Songklanakarind Hospital

Jitsupa Kittarakul, Bsc.PT

Study Director

Physical Therapy unit, Songklanakarind Hospital

Boonmas Chansirimongkol, B.N.S.

Study Director

Medical Respiratory Care Unit, Prince of Songklanakarind Hospital

Kwankamol Kalsri, B.N.S

Study Director

Medical Respiratory Care Unit, Prince of Songklanakarind Hospital

Assoc.Prof.Siwasak Juthong, MD

Study Director

Division of Respiratory and Respiratory Critical Care Medicine, Department of Internal Medicine, PSU

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported