Intensive Care PatientsNCT06946251

Transcutaneous Diaphragm Stimulation in ICU Patients

A study testing Transcutaneous Diaphragm Stimulation in people with Intensive Care Patients, run by Karadeniz Technical University.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Official record

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Trial summary

The aim of this study is to compare the effects of transcutaneous electrical diaphragm stimulation (TEDS) on diaphragm thickness, duration of mechanical ventilation, length of ICU stay, and right/left heart functions between patient groups with low and high ejection fraction (EF) levels. Read more about this study

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Intensive Care Patients
What is being tested?: Transcutaneous Diaphragm Stimulation
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 76 participants
Where: No sites listed yet
Study dates: May 2025to May 2026
Phase: Interventional
Are there results?: Not yet: the study is under way

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 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients aged between 18 and 80 years
Patients expected to require mechanical ventilation for at least 72 hours

Who cannot join

Presence of known neuromuscular diseases that contraindicate the use of transcutaneous diaphragm stimulation
Phrenic nerve injury
History of abdominal or thoracic surgery that prevents the application of diaphragm stimulation

About this study

Official title: Evaluation of Patients With Reduced and Preserved Ejection Fraction After Transcutaneous Diaphragm Stimulation

This randomized controlled trial will record demographic data, diaphragm ultrasound measurements, and echocardiographic findings of patients who receive or do not receive TEDS for five consecutive days.

Participants will be divided into four groups according to their EF levels and whether or not they receive diaphragm stimulation:

Group 1: Patients with low EF who receive TEDS Group 2: Patients with high EF who receive TEDS Group 3: Patients with low EF who do not receive TEDS Group 4: Patients with high EF who do not receive TEDS

Diaphragm thickness and echocardiographic assessments will be performed at baseline and at the end of the five-day TEDS intervention.

TEDS Application Protocol

In the ICU, TEDS is administered by a physiotherapist once daily for 20 minutes, five days a week, as part of the routine treatment protocol. The stimulation is delivered using the LGT-231 model device from the LONGEST brand.

A transcutaneous current with a frequency of 30-50 Hz and a pulse width of 300-400 microseconds is applied to the diaphragm. The stimulation intensity is increased until visible muscle contraction is achieved.

Electrode placement involves:

The first pair of electrodes placed bilaterally between the 8th and 10th anterior intercostal spaces, lateral to the xiphoid process.

The second pair placed along the mid-axillary line of the thorax, also between the 8th and 10th intercostal spaces.

Conditions: Intensive Care Patients
Being tested: Transcutaneous Diaphragm Stimulation
Keywords: Diaphragm Stimulation, Intensive care unit, Ejection Fraction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Transcutaneous Diaphragm StimulationDevice
In the ICU, TEDS is administered by a physiotherapist once daily for 20 minutes, five days a week, as part of the routine treatment protocol. The stimulation is delivered using the LGT-231 model device from the LONGEST brand.
A transcutaneous current with a frequency of 30-50 Hz and a pulse width of 300-400 microseconds is applied to the diaphragm. The stimulation intensity is increased until visible muscle contraction is achieved.

Study groups in NCT06946251
Study group	Role	What they receive
Group 1: Patients with low EF who receive TEDS	Experimental	Not described Receives: Device: Transcutaneous Diaphragm Stimulation
Group 2: Patients with high EF who receive TEDS	Experimental	Not described Receives: Device: Transcutaneous Diaphragm Stimulation
Group 3: Patients with low EF who do not receive TEDS	No intervention	Not described
Group 4: Patients with high EF who do not receive TEDS	No intervention	Not described

What is being measured

The primary outcome is the main question the study is designed to answer.

Diaphragm Thickness and Thickening Fraction Measured by Ultrasound
Diaphragm thickness will be measured using B-mode ultrasonography. The following parameters will be assessed:
Diaphragm thickness at end-expiration (Tdi-exp), in millimeters (mm)
Diaphragm thickness at end-inspiration (Tdi-insp), in millimeters (mm)
Diaphragm thickening fraction (TF), calculated using the following formula:
TF = (Tdi-insp - Tdi-exp) / Tdi-exp × 100.
Measured: At baseline (Day 0) and on Day 5 of the study
Duration of mechanical ventilation
Length of ICU stay will be recorded in days for each patient during the 5-day study follow-up. The duration will be calculated from the date and time of ICU admission until discharge or the end of the 5-day observation period, whichever comes first. Data will be obtained from patient medical records.
Measured: At the beginning of the study and at the end of the 5-day period
Length of stay in the intensive care unit
The total number of days each patient remains in the intensive care unit (ICU) will be recorded during the 5-day follow-up period. ICU stay duration will be calculated from the time of ICU admission until ICU discharge or the end of the 5-day observation period, whichever occurs first. Data will be obtained from patient medical records.
Measured: At the beginning of the study and at the end of the 5-day period
Cardiac Function Parameters Assessed by Transthoracic Echocardiography
Cardiac function will be assessed using transthoracic echocardiography (TTE) performed by an experienced cardiologist. The following echocardiographic parameters will be recorded to evaluate both systolic and diastolic cardiac function:
E/A ratio (m/s) e' velocity (cm/s) E/e' ratio Pulmonary vein flow pattern Peak flow velocity (m/s) Left atrial volume index (mL/m²) Left ventricular ejection fraction (LVEF, %) Right atrial volume (mL) Right ventricular volume (mL) Pulse Doppler myocardial performance index (RIMP) Tissue Doppler myocardial performance index (RIMP) Fractional area change (FAC, %) Tricuspid annular plane systolic excursion (TAPSE, cm) Tissue Doppler S wave velocity (cm/s)
Measured: At baseline (Day 0) and on Day 5 of the study

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2025May 2026

First posted27 Apr 2025
Study startMay 2025 (estimated)
Primary completionFeb 2026 (estimated)
Study completionMay 2026 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Intensive Care PatientsStudies 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
Masking: None (open label)
Enrolment: 76 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06946251
Sponsor's protocol ID: 2025/9
Status last verified: Apr 2025
First submitted: 9 Apr 2025
Last updated: 27 Apr 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Interested in taking part?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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Study at a glance

From the registry record, last updated by the sponsor on 27 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of Patients With Reduced and Preserved Ejection Fraction After Transcutaneous Diaphragm Stimulation
ClinicalTrials.gov ID: NCT06946251
Acronym / sponsor ID: 2025/9
Conditions: Intensive Care Patients
Keywords: Diaphragm Stimulation, Intensive care unit, Ejection Fraction
Study type: Interventional
Recruitment status: Not yet recruiting
Enrolment: 76 participants (estimated)
Lead sponsor: Karadeniz Technical UniversityUniversity, hospital or other
Study start: May 2025 (estimated)
Primary completion: Feb 2026 (estimated)
Study completion: May 2026 (estimated)
First posted: 27 Apr 2025 (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.

Participants will be divided into four groups according to their EF levels and whether or not they receive diaphragm stimulation:

Diaphragm thickness and echocardiographic assessments will be performed at baseline and at the end of the five-day TEDS intervention.

TEDS Application Protocol

Electrode placement involves:

The first pair of electrodes placed bilaterally between the 8th and 10th anterior intercostal spaces, lateral to the xiphoid process.

The second pair placed along the mid-axillary line of the thorax, also between the 8th and 10th intercostal spaces.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
Group 1: Patients with low EF who receive TEDS	Experimental	Device: Transcutaneous Diaphragm Stimulation
Group 2: Patients with high EF who receive TEDS	Experimental	Device: Transcutaneous Diaphragm Stimulation
Group 3: Patients with low EF who do not receive TEDS	No intervention	–
Group 4: Patients with high EF who do not receive TEDS	No intervention	–

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Patients aged between 18 and 80 years
Patients expected to require mechanical ventilation for at least 72 hours

Key exclusion criteria (3 listed)

Presence of known neuromuscular diseases that contraindicate the use of transcutaneous diaphragm stimulation
Phrenic nerve injury
History of abdominal or thoracic surgery that prevents the application of diaphragm stimulation

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
Transcutaneous Diaphragm StimulationIn the ICU, TEDS is administered by a physiotherapist once daily for 20 minutes, five days a week, as part of the routine treatment protocol. The stimulation is delivered using the LGT-231 model device from the LONGEST brand. A transcutaneous current with a frequency of 30-50 Hz and a pulse width of 300-400 microseconds is applied to the diaphragm. The stimulation intensity is increased until visible muscle contraction is achieved.	Device	Group 1: Patients with low EF who receive TEDS, Group 2: Patients with high EF who receive TEDS

Primary outcome

Diaphragm Thickness and Thickening Fraction Measured by Ultrasound
Time frame: At baseline (Day 0) and on Day 5 of the study
Diaphragm thickness will be measured using B-mode ultrasonography. The following parameters will be assessed: Diaphragm thickness at end-expiration (Tdi-exp), in millimeters (mm) Diaphragm thickness at end-inspiration (Tdi-insp), in millimeters (mm) Diaphragm thickening fraction (TF), calculated using the following formula: TF = (Tdi-insp - Tdi-exp) / Tdi-exp × 100.
Duration of mechanical ventilation
Time frame: At the beginning of the study and at the end of the 5-day period
Length of ICU stay will be recorded in days for each patient during the 5-day study follow-up. The duration will be calculated from the date and time of ICU admission until discharge or the end of the 5-day observation period, whichever comes first. Data will be obtained from patient medical records.
Length of stay in the intensive care unit
Time frame: At the beginning of the study and at the end of the 5-day period
The total number of days each patient remains in the intensive care unit (ICU) will be recorded during the 5-day follow-up period. ICU stay duration will be calculated from the time of ICU admission until ICU discharge or the end of the 5-day observation period, whichever occurs first. Data will be obtained from patient medical records.
Cardiac Function Parameters Assessed by Transthoracic Echocardiography
Time frame: At baseline (Day 0) and on Day 5 of the study
Cardiac function will be assessed using transthoracic echocardiography (TTE) performed by an experienced cardiologist. The following echocardiographic parameters will be recorded to evaluate both systolic and diastolic cardiac function: E/A ratio (m/s) e' velocity (cm/s) E/e' ratio Pulmonary vein flow pattern Peak flow velocity (m/s) Left atrial volume index (mL/m²) Left ventricular ejection fraction (LVEF, %) Right atrial volume (mL) Right ventricular volume (mL) Pulse Doppler myocardial performance index (RIMP) Tissue Doppler myocardial performance index (RIMP) Fractional area change (FAC, %) Tricuspid annular plane systolic excursion (TAPSE, cm) Tissue Doppler S wave velocity (cm/s)

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2025.

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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.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

A study testing Transcutaneous Diaphragm Stimulation in people with Intensive Care Patients, run by Karadeniz Technical University.

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 2 inclusion and 3 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: opening soon, as of the sponsor's last update on 27 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

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?

This study is still under way. Results are not available in the source record yet.

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?

Diaphragm Thickness and Thickening Fraction Measured by Ultrasound (time frame: At baseline (Day 0) and on Day 5 of the study). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06946251.

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 27 Apr 2025.