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CTRI Number  CTRI/2026/03/105790 [Registered on: 10/03/2026] Trial Registered Prospectively
Last Modified On: 09/03/2026
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To compare endo tracheal tube used for general anaesthesia inflation method by graph on ventilator machine method versus pressure measuring manometer and to compare the complications  
Scientific Title of Study   A prospective randomized observational study to compare the tracheal cuff inflation method guided by pressure volume loop closure versus manometer in a supine position. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Shrikanta Oak 
Designation  Additional professor 
Affiliation  Seth G.S. Medical college and KEM hospital 
Address  Room no. 139, Department of Anesthesia, First floor, OLD building, KEM Hospital, Ernest Borges Marg, Parel , Mumbai.

Mumbai
MAHARASHTRA
400066
India 
Phone  9324134023  
Fax    
Email  shrikanta_oak@yahoo.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Shrikanta Oak 
Designation  Additional professor 
Affiliation  Seth G.S. Medical college and KEM hospital 
Address  Room no. 139, Department of Anesthesia, First floor, OLD building, KEM Hospital, Ernest Borges Marg, Parel , Mumbai.

Mumbai
MAHARASHTRA
400066
India 
Phone  9324134023  
Fax    
Email  shrikanta_oak@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Dr Swaranjali Punde 
Designation  Junior Resident  
Affiliation  Seth G.S. Medical college and KEM Hospital 
Address  Room no.1501, UGPG Hostel, Seth G.S. Medical college, Parel,Mumbai.

Mumbai
MAHARASHTRA
400066
India 
Phone  9821729427  
Fax    
Email  swaranjalipunde@gmail.com  
 
Source of Monetary or Material Support  
Department of Anesthesia, GSMC and KEM Hospital, Parel, Mumbai - 400012, Maharashtra,India. 
 
Primary Sponsor  
Name  Seth GSMC and KEM Hospital Parel Mumbai Maharashtra India 
Address  KEM Hospital, PAREL, MUMBAI-400012, MAHARASHTRA, INDIA.  
Type of Sponsor  Government medical college 
 
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 
DrSwaranjali Punde  Seth GS and Kem hospital   Seth GS and Kem hospital,Parel, Mumbai -400012, Maharashtra, India
Mumbai
MAHARASHTRA 		 9821729427

swaranjalipunde@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee (IEC) -II Relating to biomedical and health research,Kem hospital, Parel  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: PCS||,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Patients whose age group is between 18 and 65years.
ASA grade 1 & ASA grade 2 patients. 
 
ExclusionCriteria 
Details  pregnant pateint
emergency cases
history of urti/lrti with in last 15 days
pateint with thyroid swelling,tracheal pathologies
bmi more than 30 kg/m2 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To compare the volume of air used to inflate the tracheal cuff using method guided by pressure volume loop closure versus manometer in a supine position.  Post operative 2 hours  
 
Secondary Outcome  
Outcome  TimePoints 
To compare the incidence of sore throat and hoarsness in both the methods.  Post operative period. 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)   20/03/2026 
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   Cuffed endotracheal tube is widely used for general anesthesia and is popularly known to maintain adequate sealing of airway against  gastro-pharyngeal aspiration along with adequate lung ventilation. It provides better seal for trachea. Pressure inside the cuff should be adequate enough to seal the trachea against but simultaneously care should be taken that the pressure should not be too high to cause harmful effects on trachea with pressure changes such as tracheal ischemia, nerve palsies, or post op complications such as sore throat, hoarsness or dysphagia. Hence, as a researcher our aim should be to find out the best method to measure the volume of air that is required to inflate the cuff.  Although manometer is considered as the gold standard and it is said that the pressure should be around 20-30 cm of h20 in manometer to achieve adequate sealing of cuff, it might not be available in every periphery or limited resources places. Hence the goal is to compare the amount of volume required to inflate the cuff by pressure volume loop closure method and manometer and to compare the post operative complications such as hoarsness and sorethroat. 
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