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CTRI Number  CTRI/2025/11/097431 [Registered on: 13/11/2025] Trial Registered Prospectively
Last Modified On: 13/11/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To compare the ease of intubation using 2 different airway introducer in artificially created difficult airway in adult patients undergoing for surgery under general anaesthesia 
Scientific Title of Study   A Comparative evaluation of AIROD vs Bougie Boussignac as an intubation adjunct in simulated difficult airway using video laryngoscope. 
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 SK Singhal 
Designation  Sr. Professor & Head  
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 
Phone  9416391115  
Fax    
Email  Ssinghal12@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Gaurav  
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 
Phone  8168999929  
Fax    
Email  gmgaurav0007@gmail.com  
 
Details of Contact Person
Public Query  
Name  Gaurav  
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 
Phone  8168999929  
Fax    
Email  gmgaurav0007@gmail.com  
 
Source of Monetary or Material Support  
Pandit B. D. Sharma University PGIMS, Rohtak, Haryana 124001  
 
Primary Sponsor  
Name  NIL 
Address  NIL 
Type of Sponsor  Other [NIL] 
 
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 Gaurav  Pt. B.D. Sharma, PGIMS  Department of Anaesthesiology and Critical Care, Modular OT Complex, Second Floor, PGIMS Rohtak Rohtak HARYANA
Rohtak
HARYANA 		 8168999929

gmgaurav0007@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Biomedical Research Ethics Committee Pt BD Sharma PGIMS Rohtak  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  , (1) ICD-10 Condition: Z138||Encounter for screening for otherspecified diseases and disorders, (2) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  AIROD telescopic steel bougie   Fully extended & locked AIROD will be lubricated and preloaded with the lubricated ETT of size 7.0 mm ID in females and 8.0 mm ID in males. The McGrath video laryngoscope will be inserted into the patient’s oral cavity. Cormack- Lehane grading will be noted. After glottic visualization in screen of video laryngoscope, AIROD will be inserted in the oropharynx. AIROD proximal tip will be used to lift the epiglottis. The introducer will be negotiated towards the trachea. It will be negotiated till 2 cm past the vocal cords. An assistant will be instructed to slide the ETT down the device. Once the intubation mark crosses the glottis, the AIROD and laryngoscope will be withdrawn. Thereafter ETT will be connected to the anesthesia circuit and anesthesia will be maintained using sevoflurane in N2O and oxygen mixture in the ratio of 50:50.  
Comparator Agent  Bougie Boussignac intubating introducer  Bougie Boussignac will be lubricated and preloaded with the lubricated ETT of size 7.0 mm ID in females and 8.0 mm ID in males. The McGrath video laryngoscope will be inserted into the patient’s oral cavity. Cormack- Lehane grading will be noted. After glottic visualization in screen of video laryngoscope, Bougie will be inserted in the oropharynx and negotiated towards the trachea. It will be negotiated till 2 cm past the vocal cords. An assistant will be instructed to slide the ETT down the device. Once the intubation mark crosses the glottis, the bougie and laryngoscope will be withdrawn. Thereafter ETT will be connected to the anesthesia circuit and anesthesia will be maintained using sevoflurane in N2O and oxygen mixture in the ratio of 50:50.  
Comparator Agent  To compare the ease of intubation using 2 different bougies: AIROD and Bougie Boussignac in simulated difficult airway  Patients will be intubated using AIROD and Bougie Boussignac in simulated difficult airway. Number of attempts taken for intubation, time taken for intubation, first pass success rate, ease of intubation, optimisation manoeuvres required for intubation and haemodynamic variations after induction, intubation, 3 minute and 5 minute after intubation will be noted 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Sixty patients belonging to American Society of Anaesthesiologists (ASA) physical status I or II scheduled for elective surgery under general anaesthesia requiring endotracheal intubation will be included in the study. 
 
ExclusionCriteria 
Details  Patients having respiratory or pharyngeal pathology, restricted mouth opening, pregnancy, full stomach, and any patient who refuses to participate in the study will be excluded from the study 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To compare the overall success rate of intubation through AIROD and Bougie Boussignac using video laryngoscope.  1.Success of intubation will be assessed after successful ETT placement through bougies 
 
Secondary Outcome  
Outcome  TimePoints 
Ease of passing the introducer.
The number of attempts taken to insert the introducer.
The total time taken for successful intubation.
Hemodynamic changes between the devices.
Complications secondary to device placement.
 		 1. Passing the introducer & number of attempts taken.
2. Mean Ease of paArterial Pressure, Heart Rate & SpO2
will be evaluated & observed at Baseline, after
induction, One minute after intubation, 3
minutes after intubation & 5 minutes after
intubation. 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   10/02/2026 
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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [kiranpreet72@rediffmail.com].

  6. For how long will this data be available start date provided 02-01-1970 and end date provided 02-01-1970?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  
This study is to compare the success and ease of intubation using AIROD and Bougie Boussignac in simulated difficult airway in adult patients aged between 18-60 years of either sex of ASA grade 1 and 2 scheduled for elective surgery requiring general anaesthesia and endotracheal intubation will be included. Number of attempts, time taken for intubation, first pass success rate of intubation, ease of intubation, optimisation manoeuvres required for intubation and haemodynamic variations will be noted. Data will be compiled, and appropriate statistical test will be used to analyze the results.
 
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