| CTRI Number |
CTRI/2022/02/040412 [Registered on: 18/02/2022] Trial Registered Prospectively |
| Last Modified On: |
17/02/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Tracheal intubation using CMAC Videolaryngoscope using different views of glottis inlet: a prospective randomized study |
|
Scientific Title of Study
|
Success and ease of tracheal intubation after obtaining maximal glottis view versus restricted view of glottis opening using C-MAC video laryngoscope: a prospective randomized study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sukhyanti Kerai |
| Designation |
Associate Professor |
| Affiliation |
Maulana Azad Medical College |
| Address |
Room No 413, 4th floor, BL Taneja Building , Maulana Azad Medical College Campus, Bahadur Shah Zafar Marg
Bahadur Shah Zafar Marg
Central
DELHI
1100002
India |
| Phone |
09968527122 |
| Fax |
|
| Email |
drsukhi25@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sukhyanti Kerai |
| Designation |
Associate Professor |
| Affiliation |
Maulana Azad Medical College |
| Address |
Room No 413, 4th floor, BL Taneja Building , Maulana Azad Medical College Campus, Bahadur Shah Zafar Marg
Bahadur Shah Zafar Marg
Central
DELHI
1100002
India |
| Phone |
09968527122 |
| Fax |
|
| Email |
drsukhi25@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
sukhyanti kerai |
| Designation |
Associate Professor |
| Affiliation |
Maulana Azad Medical College |
| Address |
Room No 413, 4th floor, BL Taneja Building , Maulana Azad Medical College Campus, Bahadur Shah Zafar Marg
Bahadur Shah Zafar Marg
Central
DELHI
1100002
India |
| Phone |
9968527122 |
| Fax |
|
| Email |
drsukhi25@gmail.com |
|
|
Source of Monetary or Material Support
|
| Operation theatre block
First, second and third floor
Lok Nayak Hospital
JLN Marg
New Delhi |
|
|
Primary Sponsor
|
| Name |
Maulana Azad Medical College and associated Lok Nayak Hospital |
| Address |
Operation theater block
First, second and third floor
Lok Nayak Hospital
New Delhi |
| 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 |
| Sukhyanti Kerai |
Lok Nayak Hospital |
Department of Anaesthesiology& Intensive Care
Operation theater block
First, second, third floor
JLN Marg
Lok Nayak Hopital
Central
DELHI |
9968527122
drsukhi25@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee MAMC |
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 |
Maximal glottis view group |
Endotracheal intubation will be done after obtaining maximal view of glottis opening using C Mac videolaryngoscope.
Endotracheal intubation will be performed be performed after induction of anaesthesia and two attempts will be permissible.If duration during intubation attempts exceeds more than 60 seconds, blade of videolaryngoscope will be removed and mask ventilation with 100% oxygen for 1 minute will be done before next attempt at intubation. |
| Intervention |
Restricted glottis view group |
Endotracheal intubation will be done after obtaining deliberate restricted view of glottis using C Mac videolaryngoscope .
Endotracheal intubation will be performed be performed after induction of anaesthesia and two attempts will be permissible.If duration during intubation attempts exceeds more than 60 seconds, blade of videolaryngoscope will be removed and mask ventilation with 100% oxygen for 1 minute will be done before next attempt at intubation. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Age 18-65 years
2.American Society of Anesthesiologists (ASA) physical status I & II
|
|
| ExclusionCriteria |
| Details |
• Predicted difficult airway
• BMI > 35kg/m2
• Pregnancy
• Patients requiring rapid sequence induction & intubation.
• Neurosurgical patients
• Patients having hypertension and /or ischemic heart disease
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Time taken for tracheal intubation |
baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Number of attempts for successful tracheal intubation |
baseline |
| Number of manoeuvres for facilitating tracheal intubation |
baseline |
| Operator comfort score for ease of intubation |
baseline |
| Any injury to dentition or oropharyngeal mucosa |
baseline |
|
|
Target Sample Size
|
Total Sample Size="166"
Sample Size from India="166"
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)
|
24/02/2022 |
| 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
|
NA |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [drsukhi25@gmail.com].
- For how long will this data be available start date provided 24-11-2023 and end date provided 24-06-2025?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - Nil
|
|
Brief Summary
|
This prospective randomized study will be conducted on 166 patients undergoing elective surgeries under general anaesthesia. General anaesthesia will be induced using standard dosage of fentanyl, propofol and vecuronium. Patients will be randomly allocated into one of the groups ;Group F and Group R. Group F:Using Macintosh blade of C Mac video laryngoscope, full view of glottis inlet will be exposed and endotracheal intubation will be done. Group R: Using Macintosh blade of C Mac videolaryngoscope, POGO View of 50% of less will be obtained and endotracheal intubation will be done. Two attempts of intubation will be permissible. In case of failure at intubation on first attempt despite manouvers, second intubation attempt at same glottis view will be done using a styleted endotracheal tube. Total time taken for intubation, number of attempts needed,number of manouvers required for facilitaing intubation, operator comfort scale and any injuries to oropharyngeal structures and dentition.
|