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CTRI Number  CTRI/2025/07/091292 [Registered on: 21/07/2025] Trial Registered Prospectively
Last Modified On: 18/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   PROSPECTIVE OBSERVATIONAL 
Study Design  Single Arm Study 
Public Title of Study   How much air is needed to safely inflate the breathing tube cuff  
Scientific Title of Study   VOLUME OF AIR REQUIRED TO INFLATE THE ENDOTRACHEAL CUFF TO ACHIEVE INTRACUFF PRESSURE OF 25cmH2O - AN PROSPECTIVE OBSERVATIONAL STUDY 
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 CHANDRU M V 
Designation  POST GRADUATE 
Affiliation  K S HEGDE MEDICAL ACADEMY  
Address  DEPARTMENT OF ANAESTHESIOLOGY, K S HEGDE MEDICAL ACADEMY, Deralakatte, Mangalore

Dakshina Kannada
KARNATAKA
575018
India 
Phone  9620219149  
Fax    
Email  chandrunvsc97@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Manjunatha R Kamath 
Designation  Professor  
Affiliation  K S HEGDE MEDICAL ACADEMY  
Address  DEPARTMENT OF ANAESTHESIOLOGY, CONSULTANT CARDIAC ANAESTHETIST, K S HEGDE MEDICAL ACADEMY, DERALAKATTE, MANGALORE

Dakshina Kannada
KARNATAKA
575018
India 
Phone  9845412094  
Fax    
Email  manjunathrkamath@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr CHANDRU M V 
Designation  POST GRADUATE 
Affiliation  K S HEGDE MEDICAL ACADEMY  
Address  DEPARTMENT OF ANAESTHESIOLOGY, K S HEGDE MEDICAL ACADEMY, Deralakatte, Mangalore

Dakshina Kannada
KARNATAKA
575018
India 
Phone  9620219149  
Fax    
Email  chandrunvsc97@gmail.com  
 
Source of Monetary or Material Support  
nil 
 
Primary Sponsor  
Name  K S HEGDE MEDICAL ACADEMY  
Address  K S HEGDE MEDICAL ACADEMY. NITYANANDANAGAR, DERALAKATTE, MANGALORE 
Type of Sponsor  Private 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 
CHANDRU M V  K S HEGDE CHARITABLE HOSPITAL  DEPARTMENT OF ANAESTHESIOLOGY NAD CRITICAL CARE K S HEGDE CHARITABLE HOSPITAL DERALAKATTE , MANGALURU DAKSHINA KANNADA , KARNATAKA 575018
Dakshina Kannada
KARNATAKA 
08152041284

chandrunvsc97@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE , K S HEGDE MEDICAL   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 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  ASA STATUS 1, 2, 3
ELECTIVE SURGERY IN THE SUPINE POSITION UNDER GENERAL ANAESTHESIA REQUIRING ORAL ENDOTRACHEAL INTUBATION  
 
ExclusionCriteria 
Details  Difficult airway both anticipated and unanticipated.
Multiple attempts of endotracheal intubation (two or more attempts).
History of sore throat.
Known anatomical laryngotracheal abnormalities.
Surgeries in which nitrous oxide will not used or nitrous oxide discontinued intraoperatively.
Patient in whom on table extubation is not done. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
. To quantify the amount of air required to inflate the cuff to achieve intracuff pressure of 25 cmH2O under standard conditions  After endotracheal intubation and every hourly during intraoperative period 
 
Secondary Outcome  
Outcome  TimePoints 
1. To observe the anatomical changes in the trachea before and after endotracheal cuff inflation.
2. Serial monitoring of ETT intracuff pressure every hourly and to find out any variations in the intracuff pressure during intraoperative period.
3. To see the incidence of postoperative sore throat.
4. To find out whether duration of surgery affects the incidence of post operative sore throat.
 
during intraoperaive period tracheal diametres and cuff pressures will be measured and monitored
in postopertaive sore throat will be assessed in post operative period  
 
Target Sample Size   Total Sample Size="79"
Sample Size from India="79" 
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)   30/07/2025 
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="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 obtaining approval from the Institutional Ethics Committee, participants satisfying the inclusion criteria will be enrolled after obtaining informed written consent. A thorough pre-anaesthetic evaluation will be done a day prior to surgery according to standard anaesthetic protocol followed in hospital.
On the previous day thorough airway examination will be done during pre-anaesthetic check up and premedications will be prescribed as per standard protocol followed in hospital.
Once the patient is shifted to the operation theatre, standard preparations such as attaching of routine monitoring devices (electrocardiogram, pulse oximetry (SpO2), noninvasive blood pressure) will be performed. Intravenous (iv) fluids will be started after securing a suitable intravenous cannula as per standard institutional practice.
Consultant will select size of the ETT for intubation which will be recorded.
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All the patients will be preoxygenated with 100% oxygen for 3 minutes with a close-fitting mask followed by intravenous (iv) injection of Fentanyl (2 mcg/kg) . Standard Intravenous induction will be done with Propofol (2.0 mg/kg) as per standard anaesthetic protocol followed in hospital. After confirming adequate mask ventilation, muscle paralysis will be achieved with Succinylcholine (2 mg/kg) or a non depolarizing muscle relaxant as per standard institutional practice.
Male patient trachea will be intubated with an 8 or 8.5 mm internal diameter ETT and female patient trachea will be intubated with a 7.0 or 7.5 mm internal diameter ETT as per the standard institutional practice. The endotracheal intubation is done by anaesthesiologist under direct laryngoscopy.
Before cuff inflation, airway ultrasonography will be done using a 38 mm 6–13 MHz, linear ultrasound probe (L4 – 12t, GE Logique e, GE Healthcare, Chicago). The ultrasound probe will be placed transversely on the neck perpendicular to the skin. The probe will be moved cranially or caudally until the true vocal cords could be identified and transverse tracheal diameter (inter mucosal diameter and inter cartilaginous diameter) will be measured at the level just above sternal notch and transverse tracheal diameter will be noted.
In longitudinal view, at the midcuff level the distance between outer layer of ETT Cuff and the inner layer of trachea will be measured and same will be noted. Cuff will be inflated using a 10cc syringe according to manometer (PORTEX cuff pressure monitor, Germany) readings and intracuff pressure will be titrated to 25 cmH2O. Cuff will be inflated in such a way that with every ml of air intracuff pressure will be checked using manometer. Cuff will be inflated with air until the intracuff pressure 25 cmH2O is achieved. Once cuff is inflated to a pressure of 25 cmH2O, anterior part of the neck over trachea will be auscultated to note any audible leak around the ETT cuff.
 After cuff inflation, airway ultrasonography will be done using a 38 mm 6–13 MHz, linear ultrasound probe (L4 – 12t, GE Logique e, GE Healthcare, Chicago). The ultrasound probe will be placed transversely on the neck perpendicular to the skin. The probe will be moved cranially or caudally until the true vocal cords could be identified and transverse tracheal diameter (inter mucosal diameter and inter cartilaginous diameter) will be measured at the level just above sternal notch and will be noted.
In longitudinal view, at the midcuff level the distance between outer layer of ETT cuff and the inner layer of trachea will be measured and same will be noted.Anaesthesia will be maintained with Isoflurane or Sevoflurane, a volatile anaesthetic agent, in
a combination of nitrous oxide and oxygen as per standard protocol followed in hospital.
Serial monitoring of intracuff pressure will be done every hourly and intracuff pressure
adjusted according to readings in the manometer by inflating or deflating the cuff. The
amount of air removed or amount of air added to maintain intracuff pressure of 25 cmH2O
will be noted.
Once patient is shifted to postoperative ward, presence of sore throat will be looked for and
will be recorded at zero, sixth and twenty fourth hour.
Sore throat will be evaluated while resting using a four-point scale (severe, moderate, mild,
or none), which is defined as follows:
1. Severe sore throat (hoarseness or change in voice that was considered to be throat
distress).
2. Moderate sore throat (patient-volunteered complaints of sore throat.
3. Mild sore throat (complaints of sore throat reported only after enquiring).
4. None.
Total duration of the procedure and intraoperative positional changes if any will be recorded.
 
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