| CTRI Number |
CTRI/2026/01/100141 [Registered on: 01/01/2026] Trial Registered Prospectively |
| Last Modified On: |
30/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
Learning curve of intubation with videolaryngoscopes in simulated difficult airway: A Comparative study. |
|
Scientific Title of Study
|
Comparison of learning curve of endotracheal intubation using videolaryngiscopes (TAscope vs i-view) in simulated difficult airway scenario. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shilpa Popli |
| Designation |
Associate Professor |
| Affiliation |
Pt. B D Sharma PGIMS Rohtak |
| Address |
Department of Anaesthesiology and Critical Care,2nd floor, OT complex, PGIMS
Rohtak, Haryana
Rohtak
HARYANA
124001
India |
| Phone |
7009878553 |
| Fax |
|
| Email |
shilpapopli89@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vritika Malik |
| Designation |
Postgraduate Student |
| Affiliation |
Pt. B D Sharma PGIMS Rohtak |
| Address |
Department of Anaesthesiology and Critical Care, 2nd, OT Complex, PGIMS Rohtak, Haryana
Rohtak
HARYANA
124001
India |
| Phone |
9996197920 |
| Fax |
|
| Email |
vritika.malik@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Vritika Malik |
| Designation |
Postgraduate Student |
| Affiliation |
Pt. B D Sharma PGIMS Rohtak |
| Address |
Department of Anaesthesiology and Critical Care, 2nd floor, OT Complex, PGIMS Rohtak, Haryana
Rohtak
HARYANA
124001
India |
| Phone |
9996197920 |
| Fax |
|
| Email |
vritika.malik@gmail.com |
|
|
Source of Monetary or Material Support
|
| Pt B D Sharma PGIMS, Rohtak |
|
|
Primary Sponsor
|
| Name |
Nil |
| Address |
Nil |
| Type of Sponsor |
Other [Nil] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Vritika Malik |
Pt. B D Sharma PGIMS Rohtak |
Department of Anaesthesiology and Critical Care, 2nd floor, OT Complex, PGIMS Rohtak
Rohtak
HARYANA |
9996197920
vritika.malik@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Biomedical Research Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K801||Calculus of gallbladder with othercholecystitis, (2) ICD-10 Condition: K118||Other diseases of salivary glands, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Intubation using i-view |
After patients arrival in the operating room standard monitoring will be established, baseline reading of vital parameters will be recorded. Intravenous access secured. Induction with Inj. Fentanyl 2mcg/kg, Inj. Propofol 2mg/kg, Inj. Atracurium 0.5mg/kg. Bag and mask ventilation of patient’s lungs with MAC 1 inhalational agent in 100% O2 using anatomical mask with patient’s head in sniffing position will be done for 3 minutes using EC clamp technique. A semi rigid cervical collar of appropriate size will then be applied around the neck. Endotracheal intubation will be performed using i-view.After obtaining adequate view of the larynx, tube will be railroaded over bougie.Data related to intubation will be recorded by an independent observer. |
| Intervention |
Intubation using TAscope |
After patients arrival in the operating room standard monitoring will be established, baseline reading of vital parameters will be recorded. Intravenous access secured. Induction
with Inj. Fentanyl 2mcg/kg, Inj. Propofol 2mg/kg, Inj. Atracurium 0.5mg/kg. Bag and mask ventilation of patient’s lungs with MAC 1 inhalational agent in 100% O2 using anatomical mask with patient’s head in sniffing position will be done for 3 minutes using EC clamp technique. A semi rigid
cervical collar of appropriate size will then be applied around the neck. Endotracheal intubation will be performed using TAscope.After obtaining adequate view of the larynx, tube will be railroaded over bougie.Data related to intubation will be recorded by an independent observer. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
American Society of Anaesthesiologists physical status I-II
Mallampati grade I or II
Thyromental distance more than 6cm
Interincisor distance more than 3.5cm
Scheduled for elective surgery under general anaesthesia and tracheal intubation |
|
| ExclusionCriteria |
| Details |
Mallampati grade III or IV
Thyromental distance less than 6cm
Interincisor distance less than 3.5cm
Restricted neck movement
Receding mandible
Facial abnormalities
Risk of regurgitation and aspiration |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the first attempt success rate of endotracheal intubation using TAscope versus i-view by anaesthesia residents. |
After the intubation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate the ease of intubation using the Fremantle score. |
At the time of intubation |
| To assess glottic visualisation using the Modified Cormack-Lehane grading & Percentage of Glottic Opening (POGO) score. |
During the time of intubation |
| To compare operator physical fatigue |
After the intubation |
|
|
Target Sample Size
|
Total Sample Size="72"
Sample Size from India="72"
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)
|
13/01/2026 |
| 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="0"
Months="9"
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
|
The study aims at comparing learning curve of endotracheal intubation using affordable V ideolaryngoscopes in simulated difficult airway. Residents will be trained initially on manikins fllowing which they’ll be randomly allocated into groups with T’AScope/i-view. First attempt success rate will be taken as the primary objective to know the success rate of TAScope or i-view |