| CTRI Number |
CTRI/2025/10/095650 [Registered on: 06/10/2025] Trial Registered Prospectively |
| Last Modified On: |
03/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Study Comparing Two Devices TAScope and McCoy Laryngoscope For Safer placement of Breathing Tube in Patients with Neck Immobilisation |
|
Scientific Title of Study
|
Comparison Of TAScope And McCoy Laryngoscope For Endotracheal Intubation In Patients With Cervical Spine Immobilisation A Prospective Randomised Study |
| 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 Ravikumar |
| Designation |
Junior Resident |
| Affiliation |
Sapthagiri Institute of Medical Sciences and Research Centre |
| Address |
Department of Anaesthesiology Sapthagiri Institute of medical sciences and Research Centre 15 Hesarghatta Rd Navy Layout Chikkabanavara Bengaluru Karnataka
Bangalore
KARNATAKA
560090
India |
| Phone |
8904226383 |
| Fax |
|
| Email |
Surpurravikumar4@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR Vinod Basappa Hosalli |
| Designation |
Professor |
| Affiliation |
Sapthagiri Institute of Medical Sciences and Research Centre |
| Address |
Department Of Anesthesiology Sapthagiri Institute of Medical Sciences and Research Centre 15 Hesarghatta Road Navy Layout Chikkabanavara Bengaluru Karnataka
Bangalore
KARNATAKA
560090
India |
| Phone |
08022186702 |
| Fax |
|
| Email |
simsanaesthesiology@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR Vinod Basappa Hosalli |
| Designation |
Professor |
| Affiliation |
Sapthagiri Institute of Medical Sciences and Research Centre |
| Address |
Department Of Anesthesiology Sapthagiri Institute of Medical Sciences and Research Centre 15 Hesarghatta Road Navy Layout Chikkabanavara Bengaluru Karnataka
Bangalore
KARNATAKA
560090
India |
| Phone |
08022186702 |
| Fax |
|
| Email |
simsanaesthesiology@gmail.com |
|
|
Source of Monetary or Material Support
|
| saptagiri institute of medical sciences 15 Hesarghatta Rd Navy Layout Chikkabanavara Bengaluru Karnataka India 560090 |
|
|
Primary Sponsor
|
| Name |
Saptagiri Institute of Medical sciences |
| Address |
Department of Anesthesiology Sapthagiri Institute of Medical Sciences and Research Centre 15 Hesarghatta Rd Navy Layout AGB layout Chikkabanavara Bengaluru Karnataka 560090 |
| Type of Sponsor |
Private 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 Ravikumar |
Sapthagiri hospital |
Sapthagiri Institute of Medical Sciences and Research Centre 15 Hesarghatta Rd Navy Layout AGB layout Chikkabanavara Bengaluru Karnataka 560090
Bangalore
KARNATAKA |
8904226383
surpurravikumar4@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics committee of Sapthagiri institute of medical sciences and research centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 8||Other Procedures, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Between McCoy laryngoscope and TAScope. |
Group M McCoy Laryngoscope will be introduced from the right side of the oral cavity And its tip advanced till the vallecula and lever activated to visualize glottis under direct vision |
| Intervention |
TAScope an Indigenous Videolaryngoscope its intervention tool for endotracheal intubation |
Group T TAScope will be introduced and under direct Observation in video screen bougie will be inserted via the vocal cords and endotracheal tube railroaded over the bougie. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Age 18 to 65 years
2.Patient willing to give informed consent
3.ASA(American society of anesthesiologists) grade 1 and 2
4.BMI of less than or equal to 30 kg/m²
5.Patients undergoing elective surgical procedures under general anaesthesia with endotracheal intubation
6. Mallampati grade I and II |
|
| ExclusionCriteria |
| Details |
1. Patients with difficult intubation and suspected difficult airway as assessed in pre-anaesthetic evaluation
2. Patients with cervical instability
3. Pregnant and lactating females
4. Patients with hemodynamic and respiratory co- morbidities |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Will be assessed for difficult intubation based on intubation difficulty scale(IDS). It’s quantitative scale of seven variables assessing the complexity of tracheal intubation. An IDS of zero is best, IDS of 1-5 is slightly difficult, IDS of greater than 5 is moderate to major difficulty. |
Will be assessed base line haemodynamic parameters
Before intubation then immediately after intubation at T0 seconds Then after 2 minutes at 4 minutes at 6 minutes at 8 minutes and at 10 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Hemodynamic parameters Heart rate, Blood pressure, mean arterial pressure, peripheral oxygen saturation at baseline(B), before intubation (BI) immediately after intubation (T0) and later at 2,4,6,8,10 Mins will be noted. |
baseline(B), before intubation (BI) immediately after intubation (T0) and later at 2,4,6,8,10 Mins will be noted. |
|
|
Target Sample Size
|
Total Sample Size="110"
Sample Size from India="110"
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)
|
30/10/2025 |
| 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="6"
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
|
Need for study: Cervical spine injury is present in around 3.7% of trauma victims and approximately 42% of these patients have unstable cervical spine. Minimizing movement with a cervical collar or by manual-in-line stabilisation becomes necessary in such cases. This makes laryngoscopy and tracheal intubation using conventional McCoy laryngoscope more difficult. Videolaryngoscopes have the advantage of containing miniature video cameras that provide indirect glottic view without requiring oral, pharyngeal and laryngeal axes alignment[1]. The management of acute spinal cord injury is a multidisciplinary effort. Therefore, the care pathway of trauma patients should emphasise prevention of secondary injuries to the cervical spine in particular. Tracheal intubation with simultaneous immobilization of the cervical spine is the recommended airway management strategy in cases of respiratory failure in trauma patients. Inadequate immobilization of the neck during intubation may result in a poor neurological outcome. Minimizing movement with a cervical collar or by manual-in-line stabilisation becomes necessary in such cases. Videolaryngoscopes have the advantage of containing miniature video cameras that provide indirect glottic view without requiring oral, pharyngeal and laryngeal axes alignment[2]. TAScope is an indigenously designed video laryngoscope which is a channeled and anatomically angulated video intubating aid with an endoscopic camera that can be connected to mobile phones and tablets.There are no documented studies comparing TAScope and McCoy for endotracheal intubation in patient with cervical spine immobilisation[3]. The aim of the study is to Compare of TAScope and McCoy laryngoscope for endotracheal intubation in patients with cervical spine immobilization in terms of difficulty of intubation,based on intubation difficulty scale,timing for successful intubation and haemodynamic response. |