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CTRI Number  CTRI/2024/08/072602 [Registered on: 16/08/2024] Trial Registered Prospectively
Last Modified On: 14/08/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Medical Device 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Compare two Cuff inflation technique to determine which is better. 
Scientific Title of Study   A PROSPECTIVE COMPARATIVE RANDOMISED STUDY TO EVALUATE EFFICACY OF CONVENTIONAL VS INSTRUMENTAL METHOD OF ENDOTRACHEAL TUBE CUFF PRESSURE MEASUREMENT IN PATIENTS UNDERGOING SURGERY UNDER GENERAL ANAESTHESIA. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Rochana Bakhshi 
Designation  Professor 
Affiliation  D Y Patil Hospital 
Address  Second floor , A Block Department Of Anaesthesia D Y Patil Hospital Ayyappa Temple Rd, Dr D Y Patil Vidyanagar, Sector 5, Nerul, Navi Mumbai, Maharashtra 400706

Thane
MAHARASHTRA
400709
India 
Phone  9323272151  
Fax    
Email  drrochana@yahoo.com  
 
Details of Contact Person
Scientific Query  
Name  Rochana Bakhshi 
Designation  Professor 
Affiliation  D Y Patil Hospital 
Address  Second floor , A Block Department Of Anaesthesia D Y Patil Hospital Ayyappa Temple Rd, Dr D Y Patil Vidyanagar, Sector 5, Nerul, Navi Mumbai, Maharashtra 400706

Thane
MAHARASHTRA
400709
India 
Phone  09323272151  
Fax    
Email  drrochana@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Shivendra Kumar 
Designation  Junior Resident 
Affiliation  D Y Patil Hospital 
Address  Second floor , A Block Department Of Anaesthesia D Y Patil Hospital Ayyappa Temple Rd, Dr D Y Patil Vidyanagar, Sector 5, Nerul, Navi Mumbai, Maharashtra 400706

Mumbai (Suburban)
MAHARASHTRA
400706
India 
Phone  8709271994  
Fax    
Email  drshivendrakumar2014@gmail.com  
 
Source of Monetary or Material Support  
D Y Patil Hospital 
 
Primary Sponsor  
Name  D Y Patil Hospital 
Address  second floor , A Block Department Of Anaesthesia D Y Patil Hospital Ayyappa Temple Rd, Dr D Y Patil Vidyanagar, Sector 5, Nerul, Navi Mumbai, Maharashtra 400706  
Type of Sponsor  Research institution and hospital 
 
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 Shivendra Kumar  D Y Patil Hospital  second floor , A Block Department Of Anaesthesia D Y Patil Hospital Ayyappa Temple Rd, Dr D Y Patil Vidyanagar, Sector 5, Nerul, Navi Mumbai, Maharashtra 400706
Thane
MAHARASHTRA 		 8709271994

drshivendrakumar2014@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee for Biomedical and Health Research, D. Y. Patil Deemed to be University School of Medicine, Navi-Mumbai  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 
Intervention  Manometer technique  Manometer is used to inflate the endotracheal tube cuff till 22-28 cmH2O pressure is achieved. Cuff pressure measured at time Intervals - Baseline and every 30 minutes till the end of surgery. Volume of air and cuff pressure before extubation is noted. 
Comparator Agent  Minimal audible and palpable leak test technique  Syringe is used to inflate the endotracheal tube cuff pressure with air until a minimal audible and palpable leak is absent and then pressure is monitored with the help of manometer. Time Interval - Baseline and every 30 min till the end of surgery. Volume of air and cuff pressure before extubation is noted.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Patient belonging to ASA Grade 1,Grade 2 and Grade 3.
Anticipated duration of surgery between 2-4 hours. 
 
ExclusionCriteria 
Details  Patient with anticipated difficult airway.
Patient with high risk of aspiration.
Emergency intubations.
BMI >30, Short Neck, Heavy Jaw, Morbid Obesity. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Alternation 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To evaluate difference in the Endotracheal tube cuff pressure using conventional technique and Manometer technique.  Baseline and every 30 minutes till end of procedure. 
 
Secondary Outcome  
Outcome  TimePoints 
To check changes in cuff pressure at regular intervals  Every 30 minutes 
 
Target Sample Size   Total Sample Size="140"
Sample Size from India="140" 
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   Phase 4 
Date of First Enrollment (India)   01/09/2024 
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   after endotracheal intubation during general anesthesia, the tracheal cuff is inflated with air which is a routine practice for adequacy of ventilation and prevention of aspiration. the conventional method is to inflate till palpable or audible leak is absent. The other technique is to use pressure manometer and adjust the pressure within the safe limits. study will compare efficacy of these two methods. 
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