Respiratory Physiotherapy and Diaphragm Thickness in Ventilated ICU Patients

NCT07538102 | Recruiting

• 1 other identifier: 2025-137
• Study Type: observational
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to evaluate the effect of respiratory physiotherapy on diaphragm thickness in patients receiving mechanical ventilation support in the intensive care unit. Thinning and dysfunction of the diaphragm muscle observed during mechanical ventilation complicate the extubation process and increase the risk of respiratory failure in patients. Diaphragm dysfunction prolongs ventilator use and increases ICU mortality. The main objective of this research is to determine whether respiratory physiotherapy has protective or ameliorative effects on diaphragm muscle structure and function, to optimize the ventilator weaning process, and to provide scientific contributions to the field of respiratory rehabilitation. Changes in diaphragm thickness will be objectively evaluated using ultrasonography, and the aim is to obtain evidence-based data on the effectiveness of respiratory physiotherapy.

Conditions

Diaphragm Dysfunction

Outcome Measures

Primary Outcomes (1)

• Change in Diaphragm Thickness

  Diaphragm thickness measured by ultrasonography (high-frequency linear probe, 5-15 MHz) at the right midaxillary line between the 8th and 9th ribs in the transverse plane, at end-inspiration and end-expiration. Diaphragm Thickening Fraction (DTF) calculated as: DTF (%) = \[(Inspiratory Thickness - Expiratory Thickness) / Expiratory Thickness\] × 100

  Baseline (start of mechanical ventilation), Day 5, Day 7, or discharge day (whichever comes first)

Study Arms (2)

Group A

Standard ICU physiotherapy will be applied once daily for 15-20 minutes.

Other: Standard ICU Physiotherapy

Group B

In addition to standard ICU physiotherapy once daily for 15-20 minutes, neuromuscular electrical stimulation (NMES) will be applied to the diaphragmatic region twice daily.

Device: Neuromuscular Electrical Stimulation (NMES)

Interventions

Standard ICU Physiotherapy OTHER

Standard ICU physiotherapy applied once daily for 15-20 minutes.

Group A

Neuromuscular Electrical Stimulation (NMES) DEVICE

NMES applied to the diaphragmatic region twice daily, in addition to standard ICU physiotherapy.

Group B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adult patients receiving invasive mechanical ventilation in the Anesthesia Intensive Care Unit of Hitit University Faculty of Medicine, Erol Olçok Training and Research Hospital, who meet the inclusion criteria and whose legal representatives have provided informed consent.

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Hitit University: lead

Study Sites (1)

Hitit University

Çorum, Centre, 19100, Turkey (Türkiye)

RECRUITING

Study Officials

• Ozgur Yagan, MD

  Hitit University

  STUDY CHAIR

Central Study Contacts

Muhammed Talha Kiratli, MD

CONTACT

+905538801258; drtalhakiratli@gmail.com

Selcuk Kayir, MD

CONTACT

+905053735158; drskayir@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 13, 2026
• First Posted: April 20, 2026
• Study Start: August 1, 2025
• Primary Completion: May 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: April 23, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)