| CTRI Number |
CTRI/2023/01/048986 [Registered on: 13/01/2023] Trial Registered Prospectively |
| Last Modified On: |
20/04/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia
Process of Care Changes |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
use of flexible scope along with video scope to enable passage of tube into windpipe |
|
Scientific Title of Study
|
Comparison of Tracheal Intubation using Video-laryngoscopy versus Video-laryngoscope assisted Flexible Tracheoscopy in patients with simulated Manual In-Line Stabilization - A Randomized Control Trial. |
| Trial Acronym |
not applicable |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr VijayanthiV |
| Designation |
senior resident |
| Affiliation |
JIPMER |
| Address |
Department of Anaesthesiology and Critical care, JIPMER, Puducherry- 605004
Pondicherry
PONDICHERRY
605004
India |
| Phone |
7305625129 |
| Fax |
|
| Email |
everenchantingveena@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Stalin |
| Designation |
Additional Professor |
| Affiliation |
JIPMER |
| Address |
Department of Anaesthesiology and critical care, JIPMER Puducherry.
Pondicherry
PONDICHERRY
605004
India |
| Phone |
9786397762 |
| Fax |
|
| Email |
drvstalin@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr VijayanthiV |
| Designation |
senior resident |
| Affiliation |
JIPMER |
| Address |
Department of Anaesthesiology and Critical care, JIPMER, Puducherry.
Pondicherry
PONDICHERRY
605004
India |
| Phone |
7305625129 |
| Fax |
|
| Email |
everenchantingveena@gmail.com |
|
|
Source of Monetary or Material Support
|
| JIPMER, dhanvantri nagar, gorimedu, puducherry |
|
|
Primary Sponsor
|
| Name |
JIPMER |
| Address |
Gorimedu, Puducherry |
| Type of Sponsor |
Research institution |
|
|
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 |
| Vijayanthi |
JIPMER |
Operation theatre complex, Department of Anaesthesiology and Critical care, JIPMER,Puducherry.
Pondicherry
PONDICHERRY |
7305625129
everenchantingveena@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee for Interventional Studies, JIPMER |
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 |
| Comparator Agent |
Video-laryngoscope |
video-laryngoscope assisted intubation in patients with simulated Manual In-Line Stabilization . DURATION- from larynscopy till intubation |
| Intervention |
Video-laryngoscope assisted Flexible Tracheoscopy |
Video-laryngoscope assisted Flexible Tracheoscopic intubation in patients with simulated Manual In-Line Stabilization. DURATION - from laryngoscopy till intubation |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1) Patients scheduled for elective or emergency surgery requiring general anaesthesia with tracheal intubation
2) with ASA physical status classification 1 to 33
3) with modified Mallampati class 1 and 2 |
|
| ExclusionCriteria |
| Details |
1) presence of predictors of difficult airway such as reduced mouth opening, restricted neck movements, BMI greater than 32 Kg/m2 and cervical spine pathology
2) patients requiring rapid sequence induction and intubation |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Time taken to intubate with Video-laryngoscopy Versus Video-laryngoscopy assisted Flexible Tracheoscope in patients with Manual In-Line Stabilization |
after induction of anaesthesia |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1)Rate of first attempt successful intubation between the two groups
2) Incidence of complications such as desaturation, airway injury and bleeding and post-operative throat pain |
after induction of anaesthesia |
|
|
Target Sample Size
|
Total Sample Size="158"
Sample Size from India="158"
Final Enrollment numbers achieved (Total)= "157"
Final Enrollment numbers achieved (India)="157" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/01/2023 |
| Date of Study Completion (India) |
11/03/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
results will be published after completion of trial |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
After obtaining informed consent, patients presenting for elective or emergency surgery under general anaesthesia requiring tracheal intubation will be included in the study. Pre-anaesthetic and complete airway assessment will be done before surgery. After administering pre-medication and attaching standard ASA monitors, patients will be randomized into two groups - VLS and VLF. Anaesthesia will be induced using 2 mcg/Kg Fentanyl, 2 mg/Kg propofol and 0.1 mg/Kg vecuronium. Face mask ventilation will be done for three minutes after which the pillow placed under the patient’s head will be removed. The patient’s head will be stabilized using MILS manouvre applied by an assistant standing on the left side of patient’s head. In group VLS, intubation will be performed using C-Mac Video-laryngoscope. In group VLF, C- MAC video-laryngoscope will be inserted into the patient’s oral cavity by the primary anaesthesiologist which will the be handed over to an assisting anaesthesiologist after obtaining glottic view. The primary anaesthesiologist will then intubate using the flexible Tracheoscope ( aScope, Ambu Inc.,) which has been railroded with the Endotracheal tube. Time Taken to Intubate ( TTI) will be the time taken from the insertion of video-laryngoscope into the oral cavity until the appearance of 3 square capnogram waveforms. An attempt at intubation will be defined as the attempt to insert the video-laryngoscope blade into the oral cavity. Failed intubation will be defined as failure to intubate within 2 attempts |