| CTRI Number |
CTRI/2025/11/097998 [Registered on: 24/11/2025] Trial Registered Prospectively |
| Last Modified On: |
20/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Evaluation of TASCOPE and BPL Videolaryngoscope performance in Adult Airway Management with simulated cervical spine restriction |
|
Scientific Title of Study
|
Comparison of Efficacy of Videolaryngoscope (BPL) versus The Anaesthetist Society Scope (TAScope) for Endotracheal Intubation in Adult Patients with Cervical Spine Immobilization: A Randomized Clinical Trial |
| 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 Gracy Chanu Ningombam |
| Designation |
Post Graduate Trainee |
| Affiliation |
Regional Institute of Medical Sciences |
| Address |
Department of Anaesthesiology
Regional Institute of Medical Sciences
Imphal West
MANIPUR
795004
India |
| Phone |
8101136990 |
| Fax |
|
| Email |
chanugracy806@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr L Chaoba Singh |
| Designation |
Professor |
| Affiliation |
Regional Institute of Medical Sciences |
| Address |
Department of Anaesthesiology
Regional Institute of Medical Sciences
Imphal West
MANIPUR
795004
India |
| Phone |
9436022521 |
| Fax |
|
| Email |
drchaoba@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr L Chaoba Singh |
| Designation |
Professor |
| Affiliation |
Regional Institute of Medical Sciences |
| Address |
Department of Anaesthesiology
Regional Institute of Medical Sciences
Imphal West
MANIPUR
795004
India |
| Phone |
9436022521 |
| Fax |
|
| Email |
drchaoba@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology
Regional Institute of Medical Sciences
Imphal West
Manipur 795004 |
|
|
Primary Sponsor
|
| Name |
Regional Institute of Medical Sciences |
| Address |
Department of Anaesthesiology Regional Institute of Medical Sciences Imphal West
Manipur 795004 |
| Type of Sponsor |
Government medical college |
|
|
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 |
| Dr Gracy Chanu Ningombam |
Regional Institute of Medical Sciences |
Operation Theatre Complex
Department of Anaesthesiology Regional Institute of Medical Sciences
Imphal West
MANIPUR |
8101136990
chanugracy806@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Research Ethics Board, RIMS, Imphal |
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 |
The Anaesthetist Society Scope (TAScope) |
TASCOPE intervention will be done till successful endotracheal intubation - from beginning of insertion of videolaryngoscope into oral cavity to insertion of endotracheal tube into the glottic opening. |
| Comparator Agent |
Videolaryngoscope (BPL) |
BPL Videolaryngoscope intubation will be done till successful endotracheal intubation - from beginning of insertion of videolaryngoscope into oral cavity to insertion of endotracheal tube into the glottic opening. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. American Society of Anaesthesiologists (ASA) physical status I or II
2. Mallampati class I and II |
|
| ExclusionCriteria |
| Details |
1. Patients with active infections or burns over the neck
2. Pregnant females
3. Patients with suspected or diagnosed cervical spine instability
4. Patients with Mallampati class III or IV, limited mouth opening of less than 2.5 cm, thyromental distance less than 6 cm, Temporo-mandibular joint dysfunction
5. Patients with active upper respiratory tract infection
6. Patients with congenital upper airway anomalies
7. Patients with body mass index (BMI) more than 30 kg per m2
8. Patients undergoing head and neck surgeries requiring throat pack
9. Patients requiring rapid sequence induction of anaesthesia and endotracheal intubation |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Time to laryngoscopy
Time to intubate
Time for successful intubation
Grade of laryngoscopic view |
At baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Number of attempts
Manoeuvres
Complications during & immediately after intubation |
At baseline |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
20/12/2025 |
| 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="1"
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
|
This study will be a single-blinded randomized clinical trial to compare the efficacy of BPL videolaryngoscope versus The Anaesthetist Society Scope (TAScope) for endotracheal intubation in adult patients with cervical spine immobilization with Philadelphia collar. After approval from the Research Ethics Board of RIMS, Imphal, a total number of 70 consenting patients (18 to 60 years, ASA I and II, Mallampati class I and II) will be randomized into one of the two groups of 35 each. In group A patients, the BPL videolaryngoscope will be used for endotracheal intubation. In group B patients, the TAScope will be used for endotracheal intubation. Data related to the procedure will be noted by an independent observer. Time to laryngoscopy, time to intubate, time for successful intubation and grade of the laryngoscopic view will be observed as primary outcomes. As secondary outcomes, the number of attempts at laryngoscopy, manoeuvres employed to facilitate intubation and complications during and immediately after intubation with the BPL videolaryngoscope and the TAScope will be noted. Data will be analyzed using the intention-to-treat (ITT) principle. Data will be recorded in a proforma, tabulated in the Microsoft Excel software and analyzed using IBM SPSS Version 26.0 software. A p value of less than 0.05 will be considered statistically significant.
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