| CTRI Number |
CTRI/2025/03/082723 [Registered on: 19/03/2025] Trial Registered Prospectively |
| Last Modified On: |
19/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Impact of Nerve Stimulation Techniques on Breathing in Patients Using Ventilators |
|
Scientific Title of Study
|
Effectiveness of neurophysiological facilitation on respiratory parameters in mechanically ventilated patients |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prantika Deb |
| Designation |
Post graduate Student |
| Affiliation |
SRM college of physiotherapy SRM institute of science and technology |
| Address |
Room no PT05 5TH Floor SRM college of physiotherapy SRM institute of science and technology SRM nagar potheri kattankulathur
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
9101575521 |
| Fax |
|
| Email |
pd6984@srmist.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
D Anandhi |
| Designation |
Professor |
| Affiliation |
SRM college of physiotherapy SRM institute of science and technology |
| Address |
Room no PT14 5TH Floor SRM college of physiotherapy SRM institute of science and technology SRM nagar potheri kattankulathur
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
9884299924 |
| Fax |
|
| Email |
anandhid@srmist.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
D Anandhi |
| Designation |
Professor |
| Affiliation |
SRM college of physiotherapy SRM institute of science and technology |
| Address |
Room no PT14 5TH Floor SRM college of physiotherapy SRM institute of science and technology SRM nagar potheri kattankulathur
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
9884299924 |
| Fax |
|
| Email |
anandhid@srmist.edu.in |
|
|
Source of Monetary or Material Support
|
| SRM college of physiotherapy SRM institute of science and technology SRM nagar Potheri Kattankulathur Tamil Nadu 603203 India |
|
|
Primary Sponsor
|
| Name |
SRM college of physiotherapy SRM institute of science and technology |
| Address |
Room no PT05 5TH Floor SRM college of physiotherapy SRM institute of science and technology SRM nagar potheri kattankulathur
Kancheepuram
TAMIL NADU
603203
India |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Prantika Deb |
SRM Medical college Hospital And Research Centre |
First floor ICU Complex neurosurgery ICU fourth floor Critical care ICU SRM Medical College Hospital And Research Centre SRM nagar Potheri Kattankulathur Kancheepuram Tamil Nadu 603203
Kancheepuram
TAMIL NADU |
9101575521
pd6984@srmist.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE |
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 |
Conventional physiotherapy treatment will be the given to the patients |
Conventional physiotherapy treatment will be given to the ventilated patient for 20 minutes once on the same day |
| Intervention |
Neurophysiological facilitation techniques will be given to the patients |
Neurophysiological facilitation techniques will be given to the ventilated patient 1 time in the morning for 15 minutes with each technique given 10 times |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
1 Both male and female patients will be selected
2 Patients who are under Mechanical Ventilation mode volume control or assist mandatory or intermittent mandatory ventilation
3 Patients who are unconscious due to medical conditions
4 Patients who are moderately sedated
5 patients who are in endotracheal tube and tracheostomy
6 Patients under grade minus one to minus four according to Richmonds Agitation Sedation Scale |
|
| ExclusionCriteria |
| Details |
1 Conscious oriented alert
2 Patients in noninvasive ventilators
3 Patients who are extremely sedated
4 Patients with chest trauma or rib fracture
5 Patients with any respiratory tract infection
6 Pregnant women and children
7 Malignancies |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Richmonds agitation sedation scale
saturation of oxygen
respiratory rate
tidal volume
minute volume
static compliances and dynamic compliances |
pre assessment and post assessment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| ICU MOBILITY SCALE |
pre assessment and post assessment |
|
|
Target Sample Size
|
Total Sample Size="24"
Sample Size from India="24"
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)
|
25/03/2025 |
| 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="0"
Months="6"
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
|
BACKGROUND Mechanical ventilation is a critical life support intervention for patients with respiratory failure While it provides essential breathing support prolonged use can lead to respiratory muscle weakness This weakness is a significant concern as it can complicate weaning from ventilation and impact overall patient recovery Neurophysiological Facilitation NPF is an emerging technique that may address this issue NPF involves Application of tactile stimulation pressure Utilization of proprioception stretch These interventions aim to stimulate physiological responses in the respiratory system potentially benefiting patients with respiratory neurological and other systemic diseases affecting respiration 1 NPF has shown promising results in improving various respiratory parameters like Oxygen saturation SpO2 Respiratory rate Minute volume 2 As a passive manual technique NPF can be applied to a wide range of patients including those who are unconscious paralyzed or on mechanical ventilation 3 The respiratory system involves complex musculature and nerve supplies that can be stimulated to induce physiological changes in respiration 4 Prolonged mechanical ventilation may decrease respiratory reflex mechanisms and muscle tone in both inspiratory and expiratory muscles 5 NPF aims to improve these reflexes and respiratory tone by facilitating neural segments and stretch reflexes NPF could be a valuable complementary therapy for patients on mechanical ventilation potentially mitigating the negative effects of prolonged ventilator support on respiratory muscle function and facilitating better outcomes in critical care settings
METHODS A single arm study with two arm parallel group a 6 months randomized experimental study with pre and post intervention assessments involving 24 ICU patients at SRM medical college hospital and research centre designed to evaluate the effectiveness of a specific intervention like Neurophysiological Facilitation in ICU Complex and IMCU of SRM medical college hospital and research centre
DISCUSSION Conducting the study in a specific ICU setting ensures a controlled environment This research has the potential to contribute valuable insights into the efficacy of NPF in critical care possibly leading to improved respiratory care protocols for mechanically ventilated patients However the limitations of sample size and single center design should be considered when interpreting the results |