Respiratory Physiotherapy and Diaphragm Thickness in Ventilated ICU Patients
ConditionDiaphragm Dysfunction
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorHitit University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 18 years
Mechanically ventilated for at least 5 days
Hemodynamically stable
Unconscious (Glasgow Coma Scale indicating impaired consciousness)
Disqualifiers
Neuromuscular disease
Traumatic diaphragm injury
Thoracic deformity causing mechanical impairment of respiration
Terminal-stage patients
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Standard ICU Physiotherapy
Other interventionStandard ICU physiotherapy applied once daily for 15-20 minutes.
Neuromuscular Electrical Stimulation (NMES)
DeviceNMES applied to the diaphragmatic region twice daily, in addition to standard ICU physiotherapy.
Treatment groups
66 Participants
are divided into 2 treatment groupsGroup A: Group A1 intervention
Group B: Group B1 intervention
Trial outcomes
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
Time frame
Baseline (start of mechanical ventilation), Day 5, Day 7, or discharge day (whichever comes first)Sponsors and contacts
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Source ClinicalTrials.gov