| CTRI Number |
CTRI/2025/03/082509 [Registered on: 17/03/2025] Trial Registered Prospectively |
| Last Modified On: |
11/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Other |
|
Public Title of Study
|
Video laryngoscope and Macintosh laryngoscope |
|
Scientific Title of Study
|
Video laryngoscope versus Macintosh laryngoscope for Or tracheal intubation in critically Ill patients |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mohd Arif |
| Designation |
Junior Resident in Anesthesia department |
| Affiliation |
Era Medical College and Hospital Lucknow |
| Address |
Department of Anesthesiology Era Medical College and hospital Lucknow Era Medical college and hospital sarfarazgunj Lucknow
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
9899868942 |
| Fax |
|
| Email |
yarifkhan786@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Maj Sanjay Choubey |
| Designation |
HOD, Department of Anesthesiology |
| Affiliation |
Era Medical College and Hospital Lucknow |
| Address |
Department of Anesthesiology Era Medical College and hospital Lucknow Era Medical college and hospital sarfarazgunj Lucknow
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
9621119747 |
| Fax |
|
| Email |
sanjay.choubey@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mustahsin Malik |
| Designation |
HOD CCM Era Medical college and hospital Lucknow |
| Affiliation |
Era Medical College and Hospital Lucknow |
| Address |
ICU CC 2nd floor, Era Medical College and hospital Lucknow , sarfarazgunj Lucknow
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
9871559131 |
| Fax |
|
| Email |
mustahsin.malik@gmail.com |
|
|
Source of Monetary or Material Support
|
| ELMC & H, Lucknow, UTTAR PRADESH - 226003, INDIA |
|
|
Primary Sponsor
|
| Name |
ELMCH |
| Address |
sarfarazgunj Lucknow , UP, 226003, INDIA |
| 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 MUSTAHSIN MALIK |
Eras Lucknow Medical College and Hospital |
ICU CC ,2ND FLOOR, ELMCH LUCKNOW UTTAR PRADESH
Lucknow
UTTAR PRADESH |
9871559131
mustahsin.malik@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE OF ERAs Lucknow medical College |
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 |
INTUBATION |
TO COMPARE INTUBATION TIME AND FIRST ATTEMPT SUCCESS RATE IN BETWEEN MODIFIED VIDEO LARYNGOSCOPE AND MACINTOSH LARYNGOSCOPE |
| Comparator Agent |
MODIFIED VIDEO LARYNGOSCOPE AND MACINTOSH LARYNGOSCOPE |
TO COMPARE INTUBATION TIME AND FIRST ATTEMPT SUCCESS RATE IN ICU IN BETWEEN MODIFIED VIDEO LARYNGOSCOPE AND MACINTOSH LARYNGOSCOPE |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
ADULT PATIENTS REQUIRING INTUBATION IN EMERGENCY AND ICU |
|
| ExclusionCriteria |
| Details |
A Requirement for Rapid Sequence Intubation
Cervical Instability or Cervical Spine Injury
Obesity Class II
Increased Bleeding Tendency
Patients with suspected difficult airway
Patients with any pathology of oral cavity that could obstruct insertion of device
Inter incisor distance less than 3 cm |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| TO COMPARE INTUBATION TIME AND FIRST ATTEMPT SUCCESS RATE |
TO COMPARE INTUBATION TIME AND FIRST ATTEMPT SUCCESS RATE AT BASELINE , AND AT AFTER 1, 2 AND 3 MINUTES |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To Compare the Hemodynamic Response to Laryngoscopy
To Compare Incidence of Desaturation and to note any other Complications |
1 MINUTE INTERVAL |
|
|
Target Sample Size
|
Total Sample Size="96"
Sample Size from India="96"
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 |
|
Date of First Enrollment (India)
|
22/03/2025 |
| 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="2"
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
|
Video laryngoscopes reduce intubation failure and make intubation easier, particularly in patients with a predicted or known difficult airway.
Their use is likely to improve the glottic view and reduce the number of laryngoscopies in which the glottis cannot be seen, irrespective of predicted or known difficulty, and may reduce the incidence of laryngeal/ airway trauma. |