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CTRI Number  CTRI/2024/03/063885 [Registered on: 08/03/2024] Trial Registered Prospectively
Last Modified On: 08/03/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Medical Device
Surgical/Anesthesia 
Study Design  Other 
Public Title of Study   To study the ease of insertion of tube for providing breaths during anaesthesia using three different technique. 
Scientific Title of Study   To evaluate the ease of endotracheal intubation using preloaded bougie vs standard bougie vs stylet guided technique in difficult airway patients undergoing elective surgeries. A randomised three arm clinical 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  Dr Suresh Rajkumar 
Designation  Professor, Department of Anaesthesiology 
Affiliation  Aarupadai veedu medical college and hospital. 
Address  A block first floor department of anaesthesiology aarupadai veedu medical college and hospital kirumampakkam.

Pondicherry
PONDICHERRY
607402
India 
Phone  9894723687  
Fax    
Email  bommidisrk@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Suresh Rajkumar 
Designation  Professor, Department of Anaesthesiology 
Affiliation  Aarupadai veedu medical college and hospital. 
Address  A block first floor department of anaesthesiology aarupadai veedu medical college and hospital kirumampakkam.

Pondicherry
PONDICHERRY
607402
India 
Phone  9894723687  
Fax    
Email  bommidisrk@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Pradeesh Johny 
Designation  Assistant Professor, Department of Anaesthesiology 
Affiliation  Aarupadai veedu medical college and hospital. 
Address  A block first floor department of anaesthesiology aarupadai veedu medical college and hospital kirumampakkam.

Pondicherry
PONDICHERRY
607402
India 
Phone  9003549061  
Fax    
Email  pradeeshjohny@gmail.com  
 
Source of Monetary or Material Support  
Aarupadai veedu medical college and hospital kirumpakkam pondicherry 607402 
 
Primary Sponsor  
Name  Aarupadai veedu medical college and hospital. 
Address  Aarupadai veedu medical college and hospital kirumpakkam pondicherry 607402  
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 
Dr Dinesh Kumar  Aarupadai veedu medical college and hospital  A block first floor department of anaesthesiology aarupadai veedu medical college and hospital kirumampakkam, pondicherry, 607402.
Pondicherry
PONDICHERRY 
9176207907

dineshkumarramesh1996@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional human ethical committee Aarupadai veedu medical college and hospital  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  Preloaded bougie   Patients undergoing elective surgeries, preloaded bougie was used for the ease of endotracheal intubation in difficult airway, duration is 3 minutes. 
Comparator Agent  Standard bougie  Patients undergoing elective surgeries, standard bougie was used for the ease of endotracheal intubation in difficult airway, duration is 3 minutes.  
Intervention  Stylet  Patients undergoing elective surgeries, stylet was used for the ease of endotracheal intubation in difficult airway, duration is 3 minutes.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. ASA I and ASA II
2. MPG 3 and 4
3. AGE: 18-60 years
4. Male and female 
 
ExclusionCriteria 
Details  1. Patients unwilling to enroll for study
2. Change in the technique of intubation
3. Patients with preoperative sore throat and upper
and lower respiratory tract infection
4. Patients with oropharyngeal pathology 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
The primary objective of the study is to compare the time taken for intubation with endotracheal tube in difficult airway patients undergoing elective surgery under general anaesthesia.  2 minutes 
 
Secondary Outcome  
Outcome  TimePoints 
Number of attempts to intubation  2 minutes 
Manipulations required to aid intubation.  3 minutes 
To assess complications like desaturation, oesophageal intubation and airway trauma during intubation.  5 minutes 
To assess incidence of post operative airway related complications like sore throat  24 hours 
 
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   Post Marketing Surveillance 
Date of First Enrollment (India)   22/03/2024 
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 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  
Successful intubation in the first attempt has been associated with lower incidence of complications. As the number of attempts and the time to intubate increase, injury to airway and risk of desaturation may increase which is potentially life threatening. Various adjuncts and techniques have been devised to facilitate ease of insertion of endotracheal tube during such situations. Tracheal tube introducer, also known as bougie, has been used extensively in difficult airway scenarios to ensure first pass success. Another technique is the use of stylet along with endotracheal tube for intubation. However, it has been noted from previous studies that the usage of bougie leads to less airway trauma as less force needs to be applied during airway manipulation. Preloaded bougie is a modification of the standard technique by which the time taken to introduce endotracheal tube can be minimised. Up to now, only stylet and standard bougie techniques were routinely being used for difficult airway intubation. In this study, we will be using preloaded bougie technique for ease of endotracheal intubation compared with standard bougie and stylet guided techniques in difficult airway.
 
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