| CTRI Number |
CTRI/2021/08/035683 [Registered on: 16/08/2021] Trial Registered Prospectively |
| Last Modified On: |
23/11/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
A clinical trial to compare three different intubating modalities in patients,while creating a difficult airway scenario by immobilizing the cervical spine |
|
Scientific Title of Study
|
Comparison of blockbuster intubating laryngeal mask airway ,channelled King Vision video laryngoscope and flexible fibreoptic scope in patients with simulated immobilized cervical spine :A Randomised Controlled Trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Neha Sinha |
| Designation |
Resident ,MD Anaesthesia |
| Affiliation |
Hamdard Institute Of Medical Sciences,New Delhi |
| Address |
Operation Theatre, 8th floor, New Hospital Building, B- block, Hamdard Institute of Medical Sciences and Research, Hamdard Nagar, New Delhi 110062
Operation Theatre, 8th floor, New Hospital Building, B- block, Hamdard Institute of Medical Sciences and Research, Hamdard Nagar, New Delhi 110062
South
DELHI
110062
India |
| Phone |
9990122034 |
| Fax |
|
| Email |
nehasinha9196@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kharat Mohd Batt |
| Designation |
Head of Department, Department of Anaesthesiology |
| Affiliation |
Hamdard Institute Of Medical Sciences,New Delhi |
| Address |
Operation Theatre, 8th floor, New Hospital Building, B- block, Hamdard Institute of Medical Sciences and Research, Hamdard Nagar, New Delhi 110062
Operation Theatre, 8th floor, New Hospital Building, B- block, Hamdard Institute of Medical Sciences and Research, Hamdard Nagar, New Delhi 110062
South
DELHI
110062
India |
| Phone |
9622457554 |
| Fax |
|
| Email |
hod.anaesthesia@himsr.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Neha Sinha |
| Designation |
Resident ,MD Anaesthesia |
| Affiliation |
Hamdard Institute Of Medical Sciences,New Delhi |
| Address |
Operation Theatre, 8th floor, New Hospital Building, B- block, Hamdard Institute of Medical Sciences and Research, Hamdard Nagar, New Delhi 110062
Operation Theatre, 8th floor, New Hospital Building, B- block, Hamdard Institute of Medical Sciences and Research, Hamdard Nagar, New Delhi 110062
South
DELHI
110062
India |
| Phone |
9990122034 |
| Fax |
|
| Email |
nehasinha9196@gmail.com |
|
|
Source of Monetary or Material Support
|
| Hamdard Institute of Medical Sciences and Research and HAHC Hospital |
|
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Primary Sponsor
|
| Name |
Hamdard Institute of Medical Sciences and Research |
| Address |
Hamdard Institute of Medical Sciences and HAHC Hospital, Hamdard Nagar, New Delhi, 110062 |
| 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 |
| Neha Sinha |
operation rooms, Hamdard Institute of Medical Sciences and Research and HAHC Hospital |
8th floor, B block, New Hospital Building, Hamdard Institute of Medical Sciences and Research and HAkeem Abdul Hameed Centenary Hospital, Hamdard Nagar 110062
South
DELHI |
9990122034
nehasinha9196@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC-HIMSR |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
channelled videolaryngoscope |
channelled videolaryngoscope is a form of indirect laryngoscopy for visulisation of the larynx transorally for intubation in patients undergoing general anaesthesia for a scheduled elective procedure |
| Comparator Agent |
Fiberoptic Bronchoscope |
Fiberoptic bronchoscope is an endoscope used for visualization and evaluation of the larynx and trachea transoral and transnasal for intubation in patients undergoing general anaesthesia for a scheduled elective procedure |
| Intervention |
Laryngeal Mask Airway |
2nd generation laryngeal mask airway is a supraglottic airway device used for ventilation and blind or fibreoptic intubation in patients undergoing general anaesthesia for a scheduled elective procedure. |
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients with American Society of Anaesthesiology (ASA) physical status I and II, of either sex, scheduled for elective surgery under general anaesthesia requiring endotracheal intubation |
|
| ExclusionCriteria |
| Details |
1. Patients refusal to give consent
2. Patients with laryngeal and pharyngeal pathology and restricted neck movements
3. Known or anticipated difficult airway ( Mallampati score 3and 4, interincisor distance < 2.5 cms, thyromental distance <6cms, sternomental distance <12cms)
4. Edentulous patients
5. Pregnant patients
6. Patients with BMI >35kg/m2
7. Patietns with clinical or radiological evidence of unstable cervical spine abnormalities |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare total time of intubation (TTI) using Blockbuster ILMA, King Vision Videolaryngoscope and Flexible Fibreoptic scope with simulated immobilized cervical spine in ASA I and II patients undergoing General Anaesthesia . |
To compare total time of intubation (TTI) at baseline. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To compare first attempt success rate between the groups.
2. To compare intubation attempts between the groups
3.To compare hemodynamic response to intubation between the groups
4. To compare intraoperative complication like trauma to lips, teeth, mucosa or other soft tissues and post-operative complications like sore throat |
Hemodynamic response- monitored over 10 minutes post intubation.
Monitor post-operative complication over 24 hours.
|
|
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Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="120" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
20/08/2021 |
| Date of Study Completion (India) |
15/09/2022 |
| 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
|
NIL |
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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 - All of the individual participant data collected during the trial, after de-identiļ¬cation.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
Response - Analytic Code
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [nehasinha9196@gmail.com].
- For how long will this data be available start date provided 01-05-2023 and end date provided 01-04-2070?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
Brief Summary
Modification(s)
|
This study is a three parallel arm randomised controlled trial, to determine weather Blockbuster intubating Laryngeal mask airway and King Vision videolaryngoscope can be used as an alternative to gold standard Flexible Fibreoptic Scope in patients with cervical immobilisation. The objectives of the study are- 1. To compare total time of intubation 2. To compare 1st attempt success rate between the groups 3. To compare intubation attempts between the groups 4. To compare hemodynamic response 5. To compare intraoperative complication like trauma to lips, teeth, mucosa and other soft tissues and post operative complications like sore throat and cough. The trial is conducted in a single centre in The operation theatres of Hamdard Institute of Medical Sciences and Research.
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