Respiratory physiotherapy to protect diaphragm thickness in ventilated ICU patients
Effect of Respiratory Physiotherapy on Diaphragmatic Thickness in Mechanically Ventilated Patients in Intensive Care Unit: A Prospective Observational Controlled Trial
This trial will try respiratory physiotherapy and neuromuscular electrical stimulation in adults on mechanical ventilation to see if they prevent diaphragm thinning and make weaning easier.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 66 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Hitit University Academic / other |
| Locations | 1 site (Çorum, Centre) |
| Trial ID | NCT07538102 on ClinicalTrials.gov |
What this trial studies
This observational study follows adult ICU patients who have been mechanically ventilated for at least five days to measure how respiratory physiotherapy and adjunctive neuromuscular electrical stimulation relate to diaphragm thickness over time. Diaphragm thickness will be measured by serial ultrasonography and correlated with clinical outcomes such as duration of mechanical ventilation and success of weaning. Patients will receive standard ICU physiotherapy with or without NMES according to clinical practice, and data will be collected at a single center. The aim is to produce objective, evidence-based data on whether these therapies protect or improve diaphragm structure and function during prolonged ventilation.
Who should consider this trial
Good fit: Adults (≥18 years) who have been mechanically ventilated for at least five days, are hemodynamically stable, and can be enrolled via informed consent from a legal representative are ideal candidates.
Not a fit: Patients with neuromuscular disease, traumatic diaphragm injury, major thoracic deformity, terminal-stage illness, pacemakers/ICDs, or other contraindications to respiratory physiotherapy may not receive benefit.
Why it matters
Potential benefit: If successful, these approaches could help preserve diaphragm muscle, shorten time on the ventilator, and reduce complications related to prolonged ICU stays.
How similar studies have performed: Prior small studies and pilot trials have reported mixed but promising results that respiratory physiotherapy and NMES can reduce ventilator-associated diaphragm atrophy and aid weaning, though larger controlled trials remain limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥ 18 years * Mechanically ventilated for at least 5 days * Hemodynamically stable * Unconscious (Glasgow Coma Scale indicating impaired consciousness) * Informed consent obtained from legal representatives Exclusion Criteria: * Neuromuscular disease * Traumatic diaphragm injury * Thoracic deformity causing mechanical impairment of respiration * Terminal-stage patients * Patients in whom respiratory physiotherapy is contraindicated * Presence of a cardiac pacemaker or implantable cardioverter-defibrillator (ICD)
Where this trial is running
Çorum, Centre
- Hitit University — Çorum, Centre, Turkey (Türkiye) (Recruiting)
Study contacts
- Study coordinator: Muhammed Talha Kiratli, MD
- Email: drtalhakiratli@gmail.com
- Phone: +905538801258
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.