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CTRI Number  CTRI/2024/07/070508 [Registered on: 12/07/2024] Trial Registered Prospectively
Last Modified On: 10/07/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross sectional observational crossover study 
Study Design  Other 
Public Title of Study   To measure and compare the intracuff pressures of endotracheal tube using three different devices in patients under general anaesthesia  
Scientific Title of Study   Comparison of intracuff pressure of Endotracheal tube with three different devices 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Deepak Longia 
Designation  Post Graduate Junior Resident 
Affiliation  Government Medical College and Hospital, Chandigarh 
Address  Department of Anaesthesia and Intensive Care, Block D, Level 5, GMCH, Sector 32B, Chandigarh

Chandigarh
CHANDIGARH
160030
India 
Phone  8178716153  
Fax    
Email  drdlongia96@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Manpreet Singh 
Designation  Professor 
Affiliation  Government Medical College and Hospital, Chandigarh 
Address  Department of Anaesthesia and Intensive Care, Block D, Level 5, GMCH, Sector 32B, Chandigarh

Chandigarh
CHANDIGARH
160030
India 
Phone  9646121503  
Fax    
Email  manpreetdawar@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Manpreet Singh 
Designation  Professor 
Affiliation  Government Medical College and Hospital, Chandigarh 
Address  Department of Anaesthesia and Intensive Care, Block D, Level 5, GMCH, Sector 32B, Chandigarh

Chandigarh
CHANDIGARH
160030
India 
Phone  9646121503  
Fax    
Email  manpreetdawar@gmail.com  
 
Source of Monetary or Material Support  
Department of Anaesthesia and Intensive Care, Block D, Level 5, GMCH, Sector 32B, Chandigarh, India, Pincode- 160030 
 
Primary Sponsor  
Name  Government Medical College and Hospital Chandigarh 
Address  Department of Anaesthesia and Intensive Care, Block D, Level 5, GMCH, Sector 32B, Chandigarh, India, Pincode- 160030 
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 
Deepak Longia  Government Medical College and Hospital , Chandigarh  Department of Anaesthesia and Intensive Care, Block D, Level 5, GMCH, Sector 32B, Chandigarh, India-160030
Chandigarh
CHANDIGARH 		 8178716153

drdlongia96@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, GMCH, Chandigarh  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 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  Adult patients aged 18 and above where ETT intubation will be done
Patients who are willing to give consent 
 
ExclusionCriteria 
Details  Those with anticipated difficult intubation
History of difficult intubation
Patients with high risk of aspiration
Known anatomical laryngotracheal abnormalities
Emergency intubation will be excluded
ETT intubation with tubes other than PVC tubes
Duration of surgery more than 2 hours 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Other 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To compare the intracuff pressures of endotracheal tube using three different devices at different moments of time during surgical procedures  0 min,30 min, 60 min, 90 min, 120 min 
 
Secondary Outcome  
Outcome  TimePoints 
To measure the hemodynamics at different moments of time when intracuff pressures are measured with all the three devices  0 min,30 min, 60 min, 90 min, 120 min 
 
Target Sample Size   Total Sample Size="270"
Sample Size from India="270" 
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)   21/07/2024 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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   All patients who will be provided general anaesthesia for any surgery will be included in this study. Standard general Anaesthesia will be administered. Premedication as per surgical procedure will be given.
General anesthesia will be induced using an intravenous propofol 2mg/kg; neuromuscular blockade will be achieved with inj. Vecuronium bromide 0.1mg/kg and then as per requirement. Male patients will be intubated with an 8 or 8.5 mm internal diameter PVC ETT, and female patients with a 7.0 or 7.5 mm internal diameter PVC ETT. Anesthesia will be maintained with sevoflurane in a combination of air and oxygen.
As soon as the ETT is inserted, the ETT cuff will be inflated with air through Cuff pressure guage appropriately mentioned in the dial i.e 25 cm water. The Cuff pressure guage will be attached to the pilot balloon with three way connector. If the ETT intracuff pressure is more than or less than 25 cm of water then it will be adjusted to 25 cm.
Immediately, at same time (0 min.), the intracuff pressure will be measured with AGCUFFILL device and then with Cuffsure device. The readings will be noted. After every 30 minutes, similarly the ETT intracuff pressure will be measured and readings will be compared statistically till 2 hours of surgical procedures. At any moment of time if the reading with Cuff pressure guage measures more than or less than 25 cm of water, the reading will be adjusted to 25 cm of water and further it will be measured by both other devices. The readings will be noted at 0 min., 30 min., 60 min. 90 min. and 120 minutes with all three devices and the Intracuff pressure readings will be noted.
The hemodynamics like heart rate, non-invasive BP, SPO2 and EtCO2 will be measured at this moments of time i.e at 0 min., 30 min.,60 min. and 120 minutes.
The mean of the intracuff pressures and mean of the heart rate, Mean blood pressure, Mean SPO2 and Mean EtCO2 will be compared with appropriate statistical tests.
 
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