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CTRI Number  CTRI/2024/09/073183 [Registered on: 02/09/2024] Trial Registered Prospectively
Last Modified On: 30/08/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A clinical trial to evaluate whether auscultation and audible leak method of Endotracheal tube cuff inflation provide better seal as compared to standard finger palpation method of cuff inflation during Endotracheal tube Cuff inflation in patients with normal airway. 
Scientific Title of Study   To compare three methods of cuff inflation in Suction Above the Cuff Endotracheal tube to achieve adequacy of seal 
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 Mangal Ahlawat 
Designation  Associate Professor 
Affiliation  Pt B D Sharma PGIMS, Rohta 
Address  Department of Anaesthesiology and critical care, Pt B D Sharma PGIMS, Rohtak Rohtak Haryana 124001 India Rohtak HARYANA 124001 India

Rohtak
HARYANA
124001
India 
Phone  9812989930  
Fax    
Email  drmangalahlawat@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Hemant Sachdeva 
Designation  Junior Resident 
Affiliation  Pt B D Sharma PGIMS, Rohtak 
Address  Department of Anaesthesiology and critical care, Pt B D Sharma PGIMS, Rohtak Rohtak Haryana 124001 India Rohtak HARYANA 124001 India
vivekaand nagar bahadurgarh haryana 124507
Rohtak
HARYANA
124001
India 
Phone  8685907820  
Fax    
Email  1002hemant@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Mangal Ahlawat 
Designation  Associate Professor 
Affiliation  Pt B D Sharma PGIMS, Rohta 
Address  Department of Anaesthesiology and critical care, Pt B D Sharma PGIMS, Rohtak Rohtak Haryana 124001 India Rohtak HARYANA 124001 India

Rohtak
HARYANA
124001
India 
Phone  9812989930  
Fax    
Email  drmangalahlawat@gmail.com  
 
Source of Monetary or Material Support  
Pt B D Sharma Post Graduate Institute of Medical Sciences , Rohtak Haryana 124001 
 
Primary Sponsor  
Name  Pt B D Sharma PGIMS, Rohtak 
Address  Department of Anaesthesiology and Critical Care, Pt B D Sharma PGIMS, Rohtak HARYANA 124001 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 
Dr Mangal Ahlawat  Pt B D Sharma PGIMS, Rohtak  Department of Anaesthesiology and critical care, Pt B D Sharma PGIMS ,Rohtak Haryana ,India 124001 Rohtak HARYANA
Rohtak
HARYANA 		 9812989930

drmangalahlawat@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Biomedical research ethics committee  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  Auditory leak guided cuff inflation in Suction Above the Cuff Endotracheal tube to achieve adequacy of seal.  In the audible leak method (group AG), the cuff will be inflated while listening for an audible leak around the tube with observer’s ear as near as possible to the mouth of the patient (maximum 5cm). The inflation will be stopped once the audible leak vanished.Initial Volume of Air ,Additional Volume Of Air and Final Volume Of Air filled in Cuff and Initial Cuff Pressure ,Final Cuff Pressure and Peak airway pressure will be noted at the time of Endotracheal tube insertion & at 60 min after Endotracheal tube insertion. 
Comparator Agent  Palpation guided cuff inflation in Suction Above the Cuff Endotracheal tube to achieve adequacy of seal.  In the palpation method (group PG), the cuff will be inflated until no leak could be palpated by 3-4 fingers placed over cricoid and upper tracheal rings. Then the ETT will be fixed. The volume required for inflation will be documented.Initial Volume of Air ,Additional Volume Of Air and Final Volume Of Air filled in Cuff and Initial Cuff Pressure ,Final Cuff Pressure and Peak airway pressure will be noted at the time of Endotracheal tube insertion & at 60 min after Endotracheal tube insertion. 
Intervention  Stethoscope guided cuff inflation in Suction Above the Cuff Endotracheal tube to achieve adequacy of seal.  In the stethoscope-guided method (group SG), the cuff will be inflated while auscultating with the bell of the littmann 3M Class III stethoscope kept over the right lamina of thyroid cartilage. The cuff will be inflated until harsh breath sound will disappear or are replaced by soft breath sounds.Initial Volume of Air ,Additional Volume Of Air and Final Volume Of Air filled in Cuff and Initial Cuff Pressure ,Final Cuff Pressure and Peak airway pressure will be noted at the time of Endotracheal tube insertion & at 60 min after Endotracheal tube insertion. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Adult Patient of either sex, aged 18-65 years with American Society of Anaesthesiologists (ASA) physical status I and II, scheduled for elective surgical procedures will be included in
the study. 
 
ExclusionCriteria 
Details  1.Anticipated Difficult airway
2. Chronic lung diseases, preoperative cough.
3. H/o recent upper respiratory infection.
4. Hoarseness of voice, sore throat, History Reflux disease/ GERD/ or increased risk of
aspiration.
6. Patient refusal.
7. Multiple attempts at intubation(greater than 3).
8. General Anaesthesia requiring nitrous oxide for maintenance 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare stethoscope guided, audible leak and palpation technique of endotracheal tube cuff inflation for adequacy of seal as determined by sub-glottic capnometry  From the time of Endotracheal tube insertion & at 60 min after Endotracheal tube insertion 
 
Secondary Outcome  
Outcome  TimePoints 
1. Initial Volume Of Air filled in Cuff
2. Additional Volume Of Air filled in Cuff
3. Final Volume Of Air filled in Cuff
4. Initial Cuff Pressure
5. Final Cuff Pressure
6. Peak airway pressure
 		 From the time of Endotracheal tube insertion & at 60 min after Endotracheal tube insertion. 
 
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   Phase 3 
Date of First Enrollment (India)   13/09/2024 
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="0"
Months="6"
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   The present prospective study will be conducted in department of anaesthesia and critical care, PGIMS, Rohtak. Written informed consent will be taken from parents included. Then comparison of auscultation, audible leak, and finger palpation method of cuff inflation in SACETT endotracheal tube will be done using subglottic capnography. Data will be compiled and analysed with appropriate statistical tests. 
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