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Respiratorisk Fysioterapi og Diafragmetykkelse hos Ventilerede Intensivpatienter

13. oktober 2026 opdateret af: Muhammed Talha KIRATLI, Hitit University

Effect of Respiratory Physiotherapy on Diaphragmatic Thickness in Mechanically Ventilated Patients in Intensive Care Unit

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.

Studieoversigt

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

66

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Age 18 years or older
  • Receiving invasive mechanical ventilation
  • Expected to require invasive mechanical ventilation for at least 7 days
  • Hemodynamically stable

Exclusion Criteria:

  • Neuromuscular disease
  • Trauma-related diaphragmatic injury
  • Chest wall deformity affecting respiration
  • Terminal stage of illness
  • Contraindication to respiratory physiotherapy
  • Presence of a cardiac pacemaker or implantable cardioverter-defibrillator (ICD)

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Group A

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

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

Aktiv komparator: 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 once daily

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

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Diaphragm Thickness
Tidsramme: Day 1, 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

Day 1, Day 5, Day 7, or discharge day (whichever comes first)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

  • Studiestol: Ozgur Yagan, MD, Hitit University

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. august 2025

Primær færdiggørelse (Faktiske)

1. maj 2026

Studieafslutning (Faktiske)

1. september 2026

Datoer for studieregistrering

Først indsendt

13. april 2026

Først indsendt, der opfyldte QC-kriterier

13. april 2026

Først opslået (Faktiske)

20. april 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

16. oktober 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

13. oktober 2026

Sidst verificeret

1. oktober 2026

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • 2025-137

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

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