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CTRI Number  CTRI/2025/09/094815 [Registered on: 15/09/2025] Trial Registered Prospectively
Last Modified On: 28/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Prospective 
Study Design  Single Arm Study 
Public Title of Study   What makes it difficult to put a breathing tube? 
Scientific Title of Study   Predictors of difficult videolaryngoscopic intubation. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
Nil  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Nambiath Sujata 
Designation  Principal Consultant 
Affiliation  Max Smart Super Speciality Hospital, Saket 
Address  A 322 GF Shivalik New Delhi

South
DELHI
110017
India 
Phone  9999109402  
Fax    
Email  drnambiath@yahoo.com  
 
Details of Contact Person
Scientific Query
 
Name  Archita Gupta 
Designation  Primary DNB student 
Affiliation  Max Smart Super Speciality Hospital, Saket 
Address  Max Smart Super Speciality Hospital, Press Enclave Road, Saket ND 110017
Max Smart Super Speciality Hospital, Press Enclave Road, Saket ND 110017
South
DELHI
110017
India 
Phone  9999109402  
Fax    
Email  guptaarchita29@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Nambiath Sujata 
Designation  Principal Consultant 
Affiliation  Max Smart Super Speciality Hospital, Saket 
Address  A 322 GF Shivalik New Delhi


DELHI
110017
India 
Phone  9999109402  
Fax    
Email  drnambiath@yahoo.com  
 
Source of Monetary or Material Support  
Max Smart Super Speciality Hospital 
 
Primary Sponsor  
Name  Max Smart Super Specilaity Hospital Saket 
Address  No1 and 2 Press Enclave Road, Saket New Delhi 11001 
Type of Sponsor  Private hospital/clinic 
 
Details of Secondary Sponsor  
Name  Address 
Max Super Speciality Hospital Saket  No1 and 2 Press Enclave Road New Delhi 110017  
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Nambiath Sujata  Max Smart Super Speciality Hospital  Press Enclave Road Saket New Delhi 110017
South
DELHI 
9999109402

drnambiath@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Max Healthcare 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 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  Elective surgery
SARI index more than 3 
 
ExclusionCriteria 
Details  Hemodynamically unstable
Emergency intubation
Pregnant patient
Patients planned for rapid sequence intubation
Mouth opening less than two finger breadth 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To find the patient factors consistently associated with a difficult intubation defined as more than
two attempts or more than 60 sec using the videolaryngoscope in patients with an anticipated
difficult airway 
2 minutes after intubation 
 
Secondary Outcome  
Outcome  TimePoints 
To find the patient factors consistently associated with Cormack Lehane Grade three or four for a nasal intubation  1 minute after intubation 
To find the patient factors consistently associated with Cormack Lehane Grade three or four for a oral intubation  1 minute after intubation 
To find the patient factors consistently associated with Cormack Lehane Grade one or two with an intubation time more than 60 sec for a nasal intubation  1 minute after intubation 
To find the patient factors consistently associated with Cormack Lehane Grade one or two with an intubation time more than 60 sec for a oral intubation  1 minute after intubation 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)   15/09/2025 
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="2"
Months="0"
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  

A thorough preoperative airway assessment will be carried out using a multiple  point predictor chart in patients with an anticipated difficult airway SARI score more than three . The demographic parameters and the presence or absence of the following predictors will be noted by an independent assessor not part of the study: Age BMI history of snoring Interncisor distance Protruding incisors Mallampati score Subluxation of Atlantooccipital joint Bite index Neck Flexion Neck Extension Neck circumference Thyrohyoid distance Thyromental distance Sternomental distance history of  difficult intubation history of radiation to neck Obscuring upper airway lesions Maxillofacial abnormality Cervical spine immobility or instability Previous head and neck resection and Planned nasal or oral intubation.

The measured indices will be defined and graded as per standard definitions. 


Prior to anaesthesia induction in the operating room, the positioning of the patients will be done by placing a seven cm high pillow beneath the head with the head in supine neutral position for intubation. After a standardized premedication and anesthesia induction, intubation would be done using the video laryngoscope. The BPL videolaryngoscope (Product of: BPL MEDICAL TECHNOLOGIES PRIVATE LIMITED, Ph: 1800-425-2355, BPL WORKS, PALAKKAD, KERALA, INDIA - 678007 ) will inserted down the midline of the mouth via the central

approach and the vocal cords will be visualized as recommended by the manufacturer. The view of the glottis displayed on the monitor screen of the videolaryngoscope will noted using the Cormack and Lehane scale. An endotracheal tubes of Internal Diameters seven mm and eight mm for female and male patients respectively, mounted on a malleable stylet in case of oral intubation with its distal end angulated upward by about sixty degrees will be inserted toward the glottis. The stylet will be removed when the tip of the endotracheal tube will be seen entering the trachea. No stylet will be used in case of nasal intubation. The cuff of the endotracheal tube will be inflated and the tube fixed in place after removing the laryngoscope from the mouth. All intubations will be performed by an experienced anaesthetist with more than twenty successful intubations with the video laryngoscope. In case of a CL grade of three or more, a BURP (Backward, Upward, Right sided Pressure) will be attempted to improve the vision of the vocal cords. The accurate positioning of the endotracheal tube will be confirmed by capnography and lung auscultation.


Ease of intubation with the videolaryngoscope will be measured using two outcomes: the time to intubate and the number of attempts needed for successful intubation. The total time to intubate  will be measured from the time the videolaryngoscope entered the patient’s mouth until the endotracheal tube was seen going through the vocal cords. An unsuccessful attempt will be recorded if the videolaryngoscope or the endotracheal tube needs to be withdrawn from the mouth. During the next attempt, the distal end of the endotracheal tube will be angulated further upward and/or the videolaryngoscope’s blade will be repositioned. The time interval from taking the endotracheal tube in the hand to the visualization of the successful passage of the tube across the vocal cord  will also be noted. If the time to intubate  is more than sixty sec whether intubation was successful or not,  it will be noted as a difficult intubation attempt. In case of more than two failed attempts to intubate the patient or more than sixty seconds time taken for intubation using Video Laryngoscope, the anaesthetist will

be allowed to use alternate devices for intubation.


The outcome of the study will be measured in terms of the number of predictors consistently associated with more than two attempts at intubation or an increased time to intubate more than sixty  seconds.


 
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