Diaphragm DysfunctionNCT07538102
Respiratory Physiotherapy and Diaphragm Thickness in Ventilated ICU Patients
A study testing Standard ICU Physiotherapy and Neuromuscular Electrical Stimulation (NMES) in people with Diaphragm Dysfunction, run by Hitit University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diaphragm Dysfunction
- What is being tested?
- Standard ICU Physiotherapy and Neuromuscular Electrical Stimulation (NMES)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2025to 1 Sep 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years or older
- Receiving invasive mechanical ventilation
- Expected to require invasive mechanical ventilation for at least 7 days
- Hemodynamically stable
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the detailed description
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.
- Conditions
- Diaphragm Dysfunction
- Being tested
- Standard ICU Physiotherapy, Neuromuscular Electrical Stimulation (NMES)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard ICU PhysiotherapyOther
Standard ICU physiotherapy applied once daily for 15-20 minutes.
Neuromuscular Electrical Stimulation (NMES)Device
NMES applied to the diaphragmatic region once daily, in addition to standard ICU physiotherapy.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | Standard ICU physiotherapy will be applied once daily for 15-20 minutes. Receives: Other: Standard ICU Physiotherapy |
| Group B | Active comparator | 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 Receives: Device: Neuromuscular Electrical Stimulation (NMES) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Day 1, Day 5, Day 7, or discharge day (whichever comes first)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2026
- Study start1 Aug 2025
- Primary completion1 May 2026
- Study completion1 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diaphragm DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients were randomized into two parallel groups. The intervention group received neuromuscular electrical stimulation (NMES) applied to the diaphragm in addition to standard respiratory physiotherapy. The control group received standard respiratory physiotherapy alone. Diaphragm thickness and thickening fraction were assessed by ultrasonography on days 1, 5, and 7.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hitit University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammed Talha KIRATLI, Hitit University
- Investigators
- Ozgur Yagan, MD, Study chair, Hitit University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07538102
- Sponsor's protocol ID
- 2025-137
- Status last verified
- Oct 2026
- First submitted
- 13 Apr 2026
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Respiratory Physiotherapy on Diaphragmatic Thickness in Mechanically Ventilated Patients in Intensive Care Unit
- ClinicalTrials.gov ID
- NCT07538102
- Acronym / sponsor ID
- 2025-137
- Conditions
- Diaphragm Dysfunction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Hitit UniversityUniversity, hospital or other
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- 1 May 2026 (actual)
- Study completion
- 1 Sep 2026 (actual)
- First posted
- 20 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Patients were randomized into two parallel groups. The intervention group received neuromuscular electrical stimulation (NMES) applied to the diaphragm in addition to standard respiratory physiotherapy. The control group received standard respiratory physiotherapy alone. Diaphragm thickness and thickening fraction were assessed by ultrasonography on days 1, 5, and 7.
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Other: Standard ICU PhysiotherapyStandard ICU physiotherapy will be applied once daily for 15-20 minutes. |
| Group B | Active comparator | Device: Neuromuscular Electrical Stimulation (NMES)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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18 years or older
- Receiving invasive mechanical ventilation
- Expected to require invasive mechanical ventilation for at least 7 days
- Hemodynamically stable
Key exclusion criteria (6 listed)
- Neuromuscular disease
- Trauma-related diaphragmatic injury
- Chest wall deformity affecting respiration
- Terminal stage of illness
- Contraindication to respiratory physiotherapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard ICU PhysiotherapyStandard ICU physiotherapy applied once daily for 15-20 minutes. | Other | Group A |
| Neuromuscular Electrical Stimulation (NMES)NMES applied to the diaphragmatic region once daily, in addition to standard ICU physiotherapy. | Device | Group B |
Primary outcome
Change in Diaphragm Thickness
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ozgur Yagan, MD study chair
Hitit University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard ICU Physiotherapy and Neuromuscular Electrical Stimulation (NMES) in people with Diaphragm Dysfunction, run by Hitit University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Diaphragm Thickness (time frame: Day 1, Day 5, Day 7, or discharge day (whichever comes first)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026.