| CTRI Number |
CTRI/2025/12/099805 [Registered on: 24/12/2025] Trial Registered Prospectively |
| Last Modified On: |
23/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Diaphragmatic Stimulation for Diaphragmatic Dysfunction as a result of Mechanical Ventilation in critically ill mechanically ventilated patients |
|
Scientific Title of Study
|
Transcutaneous Electrical Diaphragmatic Stimulation (TEDS) for Ventilator Induced Diaphragmatic Dysfunction (VIDD) in critically ill mechanically ventilated patients: A Non-Randomized Interventional Study
|
| Trial Acronym |
TEDVID |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| U1111-1329-9000 |
UTN |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Abhijith Sivasankar |
| Designation |
Senior Resident |
| Affiliation |
St. Johns Medical College Hospital |
| Address |
Department of Critical Care Medicine,
1st Floor MICU,
A Block,
St. Johns Medical College Hospital,
Sarjapur Marathahalli Road,
Beside Bank of Baroda,
John Nagar,
Koramangala,
Bangalore. Sarjapur Marathahalli Road,
Beside Bank of Baroda,
John Nagar,
Koramangala,
Bangalore,
560034 Bangalore KARNATAKA 560034 India |
| Phone |
07760947519 |
| Fax |
|
| Email |
abhijith92ledger@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Bhuvana Krishna |
| Designation |
Professor and Head of Department |
| Affiliation |
St. Johns Medical College Hospital |
| Address |
Department of Crtitical Care Medicine,
1st Floor MICU,
A Block,
St. Johns Medical College Hospital
Sarjapur Marathahalli Road,
Beside Bank of Baroda,
John Nagar,
Koramangala,
Bangalore. Sarjapur Marathahalli Road,
Beside Bank of Baroda,
John Nagar,
Koramangala,
Bangalore,
560034 Bangalore KARNATAKA 560034 India |
| Phone |
09945693221 |
| Fax |
|
| Email |
bhuvana.k@stjohns.in |
|
Details of Contact Person Public Query
|
| Name |
Dr Abhijith Sivasankar |
| Designation |
Senior Resident |
| Affiliation |
St. Johns Medical College Hospital |
| Address |
Department of Crtitical Care Medicine,
1st Floor MICU,
A Block,
St. Johns Medical College Hospital
Sarjapur Marathahalli Road,
Beside Bank of Baroda,
John Nagar,
Koramangala,
Bangalore. Sarjapur Marathahalli Road,
Beside Bank of Baroda,
John Nagar,
Koramangala,
Bangalore,
560034 Bangalore KARNATAKA 560034 India |
| Phone |
07760947519 |
| Fax |
|
| Email |
abhijith92ledger@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Abhijith Sivasankar |
| Address |
Department of Crtitical Care Medicine,
1st Floor MICU,
A Block,
St. Johns Medical College Hospital
Sarjapur Marathahalli Road,
Beside Bank of Baroda,
John Nagar,
Koramangala,
Bangalore, 560034,
Karnataka,
India. |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Abhijith Sivasankar |
St. Johns Medical College Hospital |
Department of Crtitical Care Medicine,
1st Floor MICU,
A Block,
St. Johns Medical College Hospital
Sarjapur Marathahalli Road,
Beside Bank of Baroda,
John Nagar,
Koramangala,
Bangalore,
560034. Bangalore KARNATAKA |
07760947519
abhijith92ledger@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, St. Johns National Academy of Higher Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Transcutaneous Electrical Diaphragmatic Stimulation |
As part of the intervention, the Principal Investigator shall ascertain the position of the Diaphragm using a Sonosite M-Turbo Ultrasound machine and subsequently two sets of electrodes (5X5 cms) shall be positioned on each hemithorax. The patient will be explained regarding the procedure in detail if he/she is conscious; otherwise, a surrogate will be briefed regarding the same. The physiotherapists then applied TEDS as per the ICU Physiotherapy protocol. TEDS is routinely done for spinal cord injury as per a standard operating procedure by physiotherapists in our hospital and a similar protocol will be implemented in our study.
Once the electrodes are in position, a bidirectional current with a frequency of 50 Hz and an impulse width of 300ms set to produce a palpable contraction of the muscles under the probes shall be applied bilaterally. Each cycle shall be programmed to produce 6s of stimulation and 10s of rest. The treatment will be performed twice daily with each session lasting for 20 minutes (2 per day for a maximum of 7 days). The stimulation will not be applied when the participant is under curare, in a prone position or agitated (RASS greater than 1). The care and weaning protocols shall be benchmark practice as per the ICU standard of care. TEDS stimulation will be applied until successful extubation or for 7 days whichever is earlier. The whole session will be under the constant monitoring of the PI, the co-PI’s and/or the physiotherapist. The sessions will be planned so as to have one session in the morning and the subsequent one in the evening.
An Ultrasound (USG) assessment of Diaphragmatic function as evidenced by measuring the Diaphragmatic Excursion (DE), Diaphragmatic Thickness at end-inspiration (DTpi) and end-expiration (DTee) as well as the Diaphragmatic Thickness Fraction (DTF) shall be noted on the pre-allotted days. To ascertain the diaphragmatic sonographic measurements, we have used the linear probe (5-12 Mhz) of the Sonosite M-Turbo Ultrasound machine for measuring the DTF and the curvilinear probe (2-6 Mhz) for measuring the DE. Standard of care in the form of Lung Protective Ventilation, Chest physiotherapy and Inspiratory exercises will be continued as per ICU Protocol.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. Age greater than 18 years
2. Ventilated for at least 72 hours with a further anticipated stay of 3 or more days in the unit.
3. Evidence of VIDD as defined by a DTF less than 30% and/or DE less than 15 mm measured by POCUS.
4. Consenting to participate in the study
|
|
| ExclusionCriteria |
| Details |
1. Known paralysis of the phrenic nerve
2. Known neurological conditions affecting the motor neuron or the muscle
3. Decision to withhold life-sustaining treatment
4. Patients with skin lesions, infections or strictures at point of interest
5. Patients on high dose vasopressor support
6. Severe COPD (FEV1 less than 30%)
7. Patients with implanted cardiac support systems (pacemaker, implanted defibrillator)
8. Conditions that limit diaphragm movement (e.g., high intra-abdominal pressure, ascites, pregnancy, obesity (BMI greater than 35) etc.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To ascertain the change in Diaphragmatic Thickness Fraction and Diaphragmatic Excursion pre and post application of TEDS in critically ill ventilated patients with Ventilator Induced Diaphragmatic Dysfunction. |
Days 1, 3 and 7 of Intervention and or at the time of Weaning. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To analyze the following clinical outcomes:
1. Duration of Mechanical Ventilation.
2. ICU & Hospital Length of Stay.
3. Incidence of Weaning Failure.
|
Duration of ICU & Hospital Stay |
|
|
Target Sample Size
|
Total Sample Size="58" Sample Size from India="58"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
30/01/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1" Months="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Mechanical Ventilation (MV) is one of the
most crucial forms of organ support routinely administered in the intensive
care unit (ICU), with several studies stating the proportion of patients
requiring MV reaching up to 40% (1). Mechanical ventilation is known to have
several adverse effects such as ventilator-associated pneumonia (VAP), lung
injuries and a recently widely studied issue known as Ventilator-Induced Diaphragmatic
Dysfunction (VIDD). VIDD may be defined as reduction in diaphragmatic
force-generating capacity specifically related to the use of MV accompanied by
diaphragm muscle inactivity and unloading. The prevalence of VIDD in ventilated
patients is estimated to be 60-80%, which translates to weaning failure (20%),
extended ICU stay and increased mortality (2). VIDD develops within 18-69 hours of
Mechanical Ventilation with a loss of over 50% of the cross-sectional area of
diaphragmatic muscle fibres (2). VIDD, being a major contributor to
weaning failure, necessitates longer ICU and Hospital stays for the patient
which translates to increased cost burdens and significant impacts on physical,
mental and social morbidity. Even as the entity of VIDD seems inevitable, there
are few countermeasures available within the arsenal of the Intensivist to combat
it. Lung Protective Ventilation, Ventilator Induced Lung Injury (VILI)
mitigation, early inspiratory exercises and Physiotherapy have been the only
proven therapy so far to alleviate VIDD. Electrical stimulation of the
diaphragm has a strong theoretical concept but resounding evidence for its
application is still at large. The idea is that by avoiding the disuse of the
diaphragm, its mass and function will be preserved, thereby reducing atrophy
and dysfunction. A complete lack of activity in skeletal muscle of the
diaphragm leads to atrophy, and it is postulated that only a small amount of
exercise (~200 contractions/day) is needed to prevent it (3). Transcutaneous electrical diaphragmatic
stimulation (TEDS) is a safe, non-invasive, bedside intervention that can be
applied to all critically ill patients with few exceptions. TEDS is reported to
increase the number of type II fibres, increase MIP and maximal expiratory
pressure (MEP) and decrease the rate of ventilatory weaning failure. TEDS has
been successfully integrated, as a part of the physiotherapy protocol, in
various countries for a plethora of maladies including Weaning Failure, one of
the foremost causes for which is VIDD. Point-of-Care Ultrasonography (POCUS)
provides a simple, non-invasive method of quantifying diaphragmatic movement in
a variety of normal and pathological conditions. POCUS has been successfully used to
diagnose VIDD and several international cut-offs have been postulated which has
been explained in detail further down this manuscript (4). There are very few studies done on TEDS in
critically ill patients and there’s no available literature pertaining to the
Indian population. In our proposed study we aimed to ascertain whether
implementation of TEDS in addition to standard of care, in critically ill
mechanically ventilated patients with evidence of VIDD, helps in improving
Diaphragmatic function as measured by POCUS.
VIDD is a serious entity that causes a
significant incidence of weaning failure, morbidity and mortality in critically
ill, mechanically ventilated patients. The treatment avenues at the disposal of
the intensivist are currently limited and few have proven to be effective in
mitigating VIDD. TEDS is a safe, non-invasive, bedside intervention that can be
easily applied to all critically ill patients with very few exceptions. Likewise,
measuring diaphragmatic function using POCUS is a tried and tested method and
its overall safety and repeatability makes it a feasible bedside test for the
Intensivist. The overall data on TEDS, while promising, is scarce and so far,
only a handful of studies have been conducted on the subject, with no
literature to date pertaining to the Indian populace. In our proposed study, we
put forward the research question “Among critically ill mechanically ventilated
patients with evidence of Ventilator Induced Diaphragmatic Dysfunction (VIDD),
admitted to the ICU of a tertiary care Indian hospital, will implementation of
Transcutaneous Electrical Diaphragmatic Stimulation (TEDS) in addition to
standard care help in improving Diaphragmatic function as measured by
Point-of-Care Ultrasonography (POCUS)?”. |