FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/09/074234 [Registered on: 24/09/2024] Trial Registered Prospectively
Last Modified On: 23/09/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparing Intubation Technique with flexible fiberoptic bronchoscope : Midline vs. Right Molar Approach 
Scientific Title of Study   Randomised comparative evaluation of midline approach and right molar approach for time for successful oral endotracheal intubation with flexible fiberoptic bronchoscope 
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. Pradeep 
Designation  Post Graduate Student  
Affiliation  ABVIMS and Dr. Ram Manohar Lohia Hospital, New Delhi  
Address  Room no.301 3rd floor Department Of Anaesthesia ABVIMS AND DR. RML HOSPITAL Central DELHI 110001 India

New Delhi
DELHI
110001
India 
Phone  9555927968  
Fax    
Email  psvijoriya0508@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr. Sanjeev Sharma  
Designation  Professor  
Affiliation  ABVIMS and Dr. Ram Manohar Lohia Hospital , New Delhi  
Address  Room no.301 3rd floor Department Of Anaesthesia ABVIMS AND DR. RML HOSPITAL Central DELHI 110001 India

New Delhi
DELHI
110001
India 
Phone  9873768774  
Fax    
Email  drss21@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Dr. Sanjeev Sharma  
Designation  Professor  
Affiliation  ABVIMS and Dr. Ram Manohar Lohia Hospital, New Delhi  
Address  Room no.301 3rd floor Department Of Anaesthesia ABVIMS AND DR. RML HOSPITAL Central DELHI 110001 India

New Delhi
DELHI
110001
India 
Phone  9873768774  
Fax    
Email  drss21@yahoo.com  
 
Source of Monetary or Material Support  
ABVIMS and Dr. Ram Manohar Lohia Hospital, Baba Kharak Singh Marg, Near Gurudwara Bangla Sahib, Connaught Place, New Delhi, Delhi 110001 Central DELHI 
 
Primary Sponsor  
Name  NIL 
Address  NIL 
Type of Sponsor  Other [] 
 
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 Pradeep   ABVIMS and Dr. Ram Manohar Lohia Hospital, New Delhi   Room no.301 3rd floor Department Of Anaesthesia ABVIMS AND DR. RML HOSPITAL Central DELHI 110001 India
North
DELHI 
9555927968

psvijoriya0508@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee ABVIMS and Dr. RML Hospital, New Delhi   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 
Intervention  fiberoptic bronchoscope  oral flexible fiberoptic bronchoscope inserting orally till intubation complete and confirmed at baseline  
Comparator Agent  Midline approach to flexible fiberoptic bronchoscope   Randomised comparative evaluation of midline approach for time for successful oral endotracheal intubation with flexible fiberoptic bronchoscope  
Comparator Agent  Right molar approach to flexible fiberoptic bronchoscope   Randomised comparative evaluation of right molar approach for time for successful oral endotracheal intubation with flexible fiberoptic bronchoscope  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  ASA grade – I and II
Age group 18-60 years. Healthy and intact teeth
MMPG grade I and II
Normal neck movement
Normal upper lip bite test 
 
ExclusionCriteria 
Details  Absent or loose teeth
Artificial denture
BMI more than 30 Kg/m2
Cervical spine disease
Temporomandibular joint abnormalities 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Total duration of time taken for intubation   T3 at baseline  
 
Secondary Outcome  
Outcome  TimePoints 
1. Time taken to achieve first laryngeal view T1
2. Time taken from first laryngeal view (T1) till capnographic
confirmation of orotracheal fiberoptic placement (T2)
3. Number of attempts
4. First glottis view - POGO SCORE
5. Ease of the intubation –
excellent
easy to perform
Feasible
6. Hemodynamic parameters (HR, MBP, SpO2)
7. Any adverse event like bradycardia, tachycardia, hypertension,
apnoea or injury during intubation 
T1 Time taken to achieve first laryngeal view

T2 Time taken from first laryngeal view (T1) till capnographic
confirmation of orotracheal fiberoptic placement  
 
Target Sample Size   Total Sample Size="124"
Sample Size from India="124" 
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 2/ Phase 3 
Date of First Enrollment (India)   04/10/2024 
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="3"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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  
In GROUP A, the patient’s table will be lowered to the minimum height . A pillow will be retained 
under the occiput. After 4 minutes of neuromuscular blockade, a experienced anaesthesiologist will 
position themselves at the head end of the patient to conduct fiberoptic bronchoscopy.
The fiberoptic bronchoscope will be held in the experienced anaesthesiologist’s left hand, while the 
scope sheath will be grasped between the index finger and thumb of the right hand. The mouth will 
be slightly opened using the ring finger of the right hand. Lingual traction maneuvers will be 
performed with the assistance of a trained assistant, who will place a gauze over the tongue and 
retract it manually.
The fiberoptic bronchoscope will be gradually inserted into the oral cavity using a midline approach 
toward the glottis, maintaining the scope in a midline position. The time from the removal of the face 
mask to the first view of the glottis (T1) will be recorded. As the scope tip approaches the epiglottis, 
the glottis view will be assessed and graded according to the POGO score 
In GROUP B , the table height will be minimized, while a pillow remains positioned under the occiput. 
Following a 4-minute period of neuromuscular blockade, a experienced anaesthesiologist will stand 
at the head end of the patient to conduct fiberoptic bronchoscopy.
The fiberoptic bronchoscope will be held in the anaesthesiologist’s left hand, with the scope sheath 
gripped between the index finger and thumb of the right hand. The mouth will be slightly opened 
using the ring finger of the right hand. Cheek pull maneuvers will be executed with the assistance of 
an assistant, who will place a J shaped stylet in the right cheek and retract it manually.
The fiberoptic bronchoscope will be inserted gradually into the oral cavity at the right molar 
approach toward the glottis, keeping the tip of scope above right molar and advance scope along or 
just near the right margin of tongue in the right molar approach. The time from the removal of the 
face mask (To) to the first view of the glottis (T1) will be noted. As the scope tip nears the epiglottis, 
the glottis view will be assessed and graded according to the POGO score.
After T2, in both groups, the tip of the fiberoptic bronchoscope will be advanced beyond the 
glottis into the trachea. Upon nearing the bifurcation of the trachea, visualization of the 
carina will be confirmed, and further advancement will be halted. The endotracheal tube will 
be rail loaded over the fiberoptic bronchoscope, ensuring the tube tip is positioned in the 
mid-trachea. Subsequently, the fiberoptic bronchoscope will be removed, and the cuff of the 
endotracheal tube will be adequately inflated. Anaesthesia circuit will be connected 
immediately to ETT connector followed by controlled mode of mechanical ventilation 
with tidal volume around 250-300 ml and frequency 20/min. Time taken for 
appearance of end tidal carbon dioxide (EtCO2) on the capnograph will be noted (T2)
and total intubation time will be calculated (T3=T1+T2) The endotracheal tube will be 
secured in place with tape. Fibre-scopy will be performed to assess and note any 
injury to the oropharynx & larynx. Surgery will be proceeded as per the requirement 
of Patient.
● In both the groups attempt will be abandoned if oxygen saturation falls below 97 
percent or time taken for single attempt exceeds 3 minutes.
A maximum of three attempts will be taken for successful intubation. If unsuccessful 
then subsequent alternative airway management technique such as laryngeal mask 
airway, video-laryngoscopy or direct laryngoscopy will be performed to secure 
definitive patent airway as per Difficult Airway guidelines.
 
Close