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CTRI Number  CTRI/2026/02/103276 [Registered on: 09/02/2026] Trial Registered Prospectively
Last Modified On: 07/02/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   safest endotracheal Tube Cuff Pressure in paediatric patient. 
Scientific Title of Study   Evaluation of Optimal Tracheal Tube Cuff Pressure Using Stethoscope-Guided Inflation and Expired-to-Inspired Tidal Volume Ratio Technique in Pediatric Patients Aged 2-7 Years: A Prospective 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  Annu Choudhary 
Designation  ASSOCIATE PROFESSOR 
Affiliation  Indira Gandhi Institute of Medical Sciences 
Address  Department of anaesthesia, Neuro OT Complex, First floor, Ward block, IGIMS, Patna IGIMS, Sheikhpura,Patna- 800014 Patna BIHAR 800014 India

Patna
BIHAR
800014
India 
Phone  7385161632  
Fax    
Email  anucdry@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Annu Choudhary 
Designation  Associate Professor 
Affiliation  Indira Gandhi Institute of Medical Sciences 
Address  Department of anaesthesia, Neuro OT Complex, First floor, Ward block, IGIMS, Patna IGIMS, Sheikhpura,Patna- 800014 Patna BIHAR 800014 India

Patna
BIHAR
800014
India 
Phone  7385161632  
Fax    
Email  anucdry@gmail.com  
 
Details of Contact Person
Public Query  
Name  Annu Choudhary 
Designation  Associate Professor 
Affiliation  Indira Gandhi Institute of Medical Sciences 
Address  Department of anaesthesia, Neuro OT Complex, First floor, Ward block, IGIMS, Patna IGIMS, Sheikhpura,Patna- 800014 Patna BIHAR 800014 India

Patna
BIHAR
800014
India 
Phone  7385161632  
Fax    
Email  anucdry@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Indira Gandhi Institute of Medical Sciences 
Address  Department of Anaesthesiology and CCM, Neuro OT Complex, First floor, Ward block, IGIMS, Patna 
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 
Dr ANNU CHOUDHARY  Indira Gandhi Institute of Medical Sciences  Department of Anaesthesiolgy and CCM, Neoro OT Complex, First floor, Ward block, IGIMS, Patna
Patna
BIHAR 		 7385161632

anucdry@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee, Indira Gandhi Institute of Medical Sciences, Patna  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 
Comparator Agent  SGI  Following the induction of anesthesia and endotracheal intubation, CPAP of 20 cmH2O will be held in the anesthesia circuit, and the cuff will be slowly inflated using a syringe until no air leak is heard with a stethoscope placed in the suprasternal notch. 
Intervention  Te/Ti 0.8  similar to above method, tidal volume ratio of 0.8 will be set by further removal of air from cuff. 
Intervention  Te/Ti 1.0  we will attach a pressure transducer with a stopcock to the pilot balloon of the ETT and zero at the mid-axillary line. This technique allows for air insertion and removal as well as cuff pressure measurement. After ETT intubation, the cuff will be inflated using the method of choice for the provider involved in patient care. We will place the patient on volume-guaranteed mode to achieve a TV of 10 mL/kg, with a positive end-expiratory pressure of 5 cm H2O. Finally, we will adjust the respiratory rate to maintain normocarbia. A baseline cuff pressure with the pressure transducer. Next, the air will be removed in small increments observing the spirometry. Cuff pressures will be recorded when inspired and expired TVs were equal. 
 
Inclusion Criteria  
Age From  2.00 Year(s)
Age To  7.00 Year(s)
Gender  Both 
Details  a. Pediatric patients aged 2 to 7 years.
b. Patients scheduled for elective surgery requiring general anesthesia with endotracheal intubation.
c. Use of cuffed endotracheal tube (size appropriate for age and weight).
d. American Society of Anesthesiologists (ASA) physical status I or II.
e. Written informed consent obtained from parent or legal guardian.
 
 
ExclusionCriteria 
Details  a. Anticipated difficult airway or difficult intubation (e.g., known or suspected difficult mask ventilation or laryngoscopy)
b. History of recent upper respiratory tract infection
c. Congenital or acquired craniofacial abnormalities or airway deformities,
d. History of prematurity or currently preterm neonates.
e. Pre-existing respiratory diseases such as asthma, bronchospasm, or reactive airway disease.
f. Cardiac conditions that may complicate anesthesia.
g. Emergency surgeries or procedures not allowing adequate preoperative evaluation
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Comparison of the incidence of cough immediately after extubation by Observer-Based Cough Scales (0-4).  0 min after extubation 
 
Secondary Outcome  
Outcome  TimePoints 
Comparison of mean tracheal tube cuff pressure at different time points by the different techniques.
b. Comparison of volume of air (ml) required for inflation of cuff by the different techniques. 		 0, 5, 15, 30, 45, 60, 75, 90 minutes after intubation 
 
Target Sample Size   Total Sample Size="195"
Sample Size from India="195" 
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)   20/02/2026 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  20/02/2026 
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)   Open to Recruitment 
Recruitment Status of Trial (India)  Open to Recruitment 
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   Endotracheal intubation in pediatric anesthesia requires careful management of the endotracheal tube (ETT) cuff pressure to ensure an adequate airway seal while minimizing the risk of tracheal mucosal injury. Unlike adults, children have a more delicate airway mucosa with lower mucosal capillary perfusion pressure, rendering them especially susceptible to ischemic damage from excessive cuff pressures. Maintaining ETT cuff pressures below 20 cm H2O is widely recommended in pediatrics to balance effective ventilation against the risk of mucosal injury and subsequent postoperative airway complications such as cough, sore throat, and subglottic edema. 

This study hypothesizes that the expired-to-inspired tidal volume ratio technique will yield superior outcomes in achieving optimal cuff pressures with a lower incidence of post-extubation cough compared to the stethoscope-guided inflation method in pediatric patients aged 2 to 7 years.

 
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