| 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
|
|
|
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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