FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/08/073014 [Registered on: 28/08/2024] Trial Registered Prospectively
Last Modified On: 24/08/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Process of Care Changes 
Study Design  Other 
Public Title of Study   Effects of Swallowing Exercise on Eating and Salivary Flow After Endotracheal Tube Removal  
Scientific Title of Study   EFFECTIVENESS OF SWALLOWING MANEUVER ON FUNCTIONAL ORAL INTAKE AND SALIVATION IN POST-EXTUBATED PATIENTS: A RANDOMIZED CONTROLLED TRIAL 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Priya 
Designation  Postgraduate Student 
Affiliation  All India Institute of Medical Sciences, Jodhpur, Rajasthan  
Address  Room number-1, Medical Surgical Nursing department, Critical Care Nursing division, All India Institute of Medical Sciences, Jodhpur, Basni Industrial area, Phase 2, Jodhpur, Rajasthan

Jodhpur
RAJASTHAN
342005
India 
Phone  9588308153  
Fax    
Email  priyagupta96883@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr. Suresh K. Sharma  
Designation  Professor and Principal  
Affiliation  All India Institute of Medical Sciences, Jodhpur, Rajasthan  
Address  Room number-1, Nursing department, Critical Care Nursing division, All India Institute of Medical Sciences, Jodhpur, Basni Industrial area, Phase 2, Jodhpur, Rajasthan, India.

Jodhpur
RAJASTHAN
342005
India 
Phone  8475000293  
Fax    
Email  sharmask@aiimsjodhpur.edu.in  
 
Details of Contact Person
Public Query  
Name  Priya 
Designation  Postgraduate Student 
Affiliation  All India Institute of Medical Sciences, Jodhpur, Rajasthan  
Address  Room number-1, Medical Surgical Nursing department, Critical Care Nursing division, All India Institute of Medical Sciences, Jodhpur, Basni Industrial area, Phase 2, Jodhpur, Rajasthan

Jodhpur
RAJASTHAN
342005
India 
Phone  9588308153  
Fax    
Email  priyagupta96883@gmail.com  
 
Source of Monetary or Material Support  
All India Institute of Medical Sciences, Jodhpur,Basni industrial area phase 2, Jodhpur, Rajasthan, India, Pin code: 342005 
 
Primary Sponsor  
Name  Priya 
Address  Room number-1, All India Institute of Medical Sciences, Jodhpur, Basni industrial area phase 2, Jodhpur, Rajasthan 
Type of Sponsor  Other [Myself ] 
 
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 Suresh K Sharma   All India Institute of Medical Sciences, Jodhpur  Room no- 6,Intensive Care Unit department ( Adult ICU division 3rd floor, Neurology ICU division 5th floor, Neurosurgery ICU division 5th floor, CTVS ICU division 6th floor, Trauma ICU division 2nd floor)Basni industrial area, phase 2, Jodhpur, Rajasthan
Jodhpur
RAJASTHAN 		 8475000293

sharmask@aiimsjodhpur.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee AIIMS Jodhpur  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: Z758||Other problems related to medicalfacilities and other health care,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  No intervention   No intervention will be given to the patient. 
Intervention  Swallowing maneuver   Mendelsohn Maneuver This maneuver will involve following steps: 1. Begin a regular swallow. 2. As you feel your larynx move in an upward direction, squeeze the suprahyoid muscles. 3. Maintain this position for up to 5 seconds. 4. Relax and finish the swallow. Implementation This exercise will be conducted consecutively for 5 days post-extubation with two sessions each day in 2 hour time interval and the data will be recorded on each day at 10am. This maneuver will be repeated 10 times or as tolerated by the patient during each session.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Patients who are willing to participate.
Patients who have undergone intubation for ≥48hrs.
Patient of age ≥18 yrs.
Patient who will be able to follow verbal commands.
Patients who can understand Hindi or English fluently.
 
 
ExclusionCriteria 
Details  Patient on atropine medication,cervical spinal injury, tracheostomized, history of neuromuscular disease, pathological swallowing difficulty before intubation, active respiratory infection, non- invasive mechanical ventilation post extubation. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Functional oral intake and
Amount of salivation 		 Functional oral intake on 1st 2nd, 3rd, 4th and 5th day.
Amount of salivation on 1st ,3rd and 5th day. 
 
Secondary Outcome  
Outcome  TimePoints 
N/A  N/A 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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)   09/09/2024 
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   Dysphagia is frequently observed in patients in the intensive care unit (ICU), but it often goes unnoticed and untreated, even though it’s linked to serious complications, extended ICU admissions, and longer hospital stays. Prolonged intubation (>48 hrs) can result in swallowing difficulties after extubation, impacting a person’s ability to eat properly and communicate. This study will determine the effect of swallowing maneuver on functional oral intake and amount of salivation in post-extubated patients in comparison to intervention and control group. Participants fulfilling the inclusion criteria in the ICUs of selected tertiary care teaching hospital will be recruited and randomised for the study. The functional oral intake will be determined by functional oral intake scale and amount of salivation will be determined by oral schirmer test(With participants sitting upright, a standardized 5mm-wide by 35 mm long Schirmer’s tear test strip will be placed at the floor of their mouth. At the end of 5min, a wetting length in millimetres will be recorded). Data analysis will be done by descriptive and inferential statistics. It will be done as per “Per-Protocol” analysis.

 
Close