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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  
NIL 
 
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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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)?”.

 
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