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NCT Number: NCT07538102

Respiratory Physiotherapy and Diaphragm Thickness in Ventilated ICU Patients

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hitit University

Çorum, Centre, 19100, Turkey (Türkiye)

Location status: Recruiting

Location contact

Ozgur Yagan, MD

CONTACT

About this study

Mechanical ventilation (MV) is a widely used basic life support method to provide respiratory support to individuals with life-threatening illnesses in intensive care units. However, long-term MV application and inability to wean from the ventilator are considered two of the most important risk factors increasing morbidity and mortality rates in intensive care patients. In addition, this situation creates a serious economic burden for the healthcare system. Despite the life-saving effects of MV, complications such as ventilator-associated pneumonia, atelectasis, barotrauma/volutrauma, patient-ventilator asynchrony, and pulmonary embolism can develop during the application process. Furthermore, the weaning process from mechanical ventilation is critical for enabling the patient to transition to spontaneous breathing and requires the fulfillment of objective criteria such as arterial pH, oxygenation, metabolic stability, and elimination of the underlying cause . The diaphragm, the primary muscle of the respiratory system, plays a decisive role in the successful termination of mechanical ventilation. Prolonged mechanical ventilation (MV) support leads to decreased diaphragm activity due to insufficient or excessive ventilator pressure, patient-ventilator mismatch, critical illness polyneuropathy, and systemic infections, resulting in diaphragm atrophy and dysfunction. This condition is defined as ventilator-associated diaphragm dysfunction (VIDD) and leads to prolonged MV duration, extubation failure, and increased mortality. The literature shows that VIDD is one of the most important determinants of long-term MV dependence and negatively affects clinical outcomes .

In recent years, ultrasonography (USG), a non-invasive, reliable, and reproducible method for evaluating diaphragm function, has come to the forefront. Measuring diaphragm thickness with USG provides valuable information both for the detection of VIDD and for planning the timing of extubation. In addition, early mobilization and respiratory physiotherapy applications have been shown to be effective in increasing consciousness levels, reducing complications, and shortening MV duration and ICU stay in intensive care patients . However, the effect of early respiratory physiotherapy on diaphragm structure and function has not yet been sufficiently investigated. Therefore, this study aims to evaluate the effect of respiratory physiotherapy on diaphragm thickness in intensive care patients with objective data and to determine whether it contributes to the prevention of VIDD development.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Standard ICU Physiotherapy

Other

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

Neuromuscular Electrical Stimulation (NMES)

Device

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

Primary outcomes

  1. Change in Diaphragm Thickness

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

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Muhammed Talha Kiratli, MD

CONTACT

[email protected]

+905538801258

Selcuk Kayir, MD

CONTACT

[email protected]

+905053735158

Sponsors and collaborators

Lead sponsor

Hitit University

Other

Registry information

Official study title

Effect of Respiratory Physiotherapy on Diaphragmatic Thickness in Mechanically Ventilated Patients in Intensive Care Unit: A Prospective Observational Controlled Trial

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 20, 2026
Registry last updated
May 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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