| CTRI Number |
CTRI/2020/06/025915 [Registered on: 16/06/2020] Trial Registered Prospectively |
| Last Modified On: |
10/06/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of King vision videolaryngoscopy and Direct laryngoscopy for endotracheal intubation in children |
|
Scientific Title of Study
|
Comparative analysis of endotracheal intubation with king vision ablade videolaryngoscopy with Direct laryngoscopy in pediatric population : A Prospective Randomised Control Study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Mamta Harjai |
| Designation |
Professor junior grade |
| Affiliation |
Dr.Ram Manohar Lohia Institute of Sciences |
| Address |
Department of Anesthesiology and Critical Care Medicine,
Dr Ram Manohar Lohia Institute of sciences, Vibuti khand Gomti Nagar Lucknow
Lucknow
UTTAR PRADESH
226010
India |
| Phone |
|
| Fax |
|
| Email |
mamtaharjaidoctor@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mamta Harjai |
| Designation |
Professor junior grade |
| Affiliation |
Dr.Ram Manohar Lohia Institute of Sciences |
| Address |
Department of Anesthesiology and Critical Care Medicine,
Dr Ram Manohar Lohia Institute of sciences Vibuti khand Gomti Nagar Lucknow
Lucknow
UTTAR PRADESH
226010
India |
| Phone |
|
| Fax |
|
| Email |
mamtaharjaidoctor@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Chaya Devi D |
| Designation |
Junior resident |
| Affiliation |
Dr Ram Manohar Lohia Institute of Sciences |
| Address |
Department of Anesthesiology and Critical Care Medicine,
Dr Ram Manohar Lohia Institute of Sciences Vibuti Khand Gomti Nagar Lucknow
Lucknow
UTTAR PRADESH
226010
India |
| Phone |
7259729768 |
| Fax |
|
| Email |
Chayaraghu7.cr@Gmail.Com |
|
|
Source of Monetary or Material Support
|
| Self funded by Dr Mamta Harjai, Dr Ram Manohar Lohia Institute of sciences, Vibuti khand Gomti Nagar Lucknow 226010 |
|
|
Primary Sponsor
|
| Name |
None |
| Address |
None |
| Type of Sponsor |
Other [Nothe applicable] |
|
|
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 Mamta Harjai |
Dr Ram Manohar Lohia Institute of Science |
Department of Anesthesiology and Critical Care Medicine, Dr Ram Manohar Lohia Institute of sciences, Vibuti khand Gomti Nagar Lucknow
Lucknow
UTTAR PRADESH |
8176007015
mamtaharjaidoctor@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee , Dr Ram Manohar Lohia Institute of sciences |
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 |
Direct laryngoscopy |
Endotracheal Intubation in pediatric population with Millers / Macintosh Direct laryngoscopy |
| Intervention |
Video laryngoscopy |
Endotracheal Intubation in pediatric population with King Vision ablade video laryngoscopy |
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
Pediatric patients undergoing surgery under general anesthesia
ASA physical status I-II |
|
| ExclusionCriteria |
| Details |
Congenital anomalies
URTI and LRTI
ASA> II
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Time to intubation |
Time from entry of laryngoscope blade past the lip to observation of first end tidal capnograpy after successful tracheal intubation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Number of intubation attempts
East of intubation
Overall intubation success rate
Haemodynamic changes |
Intraoperative period |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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 1 |
|
Date of First Enrollment (India)
|
16/06/2020 |
| 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="5" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
To Compare the time to intubation during indirect laryngoscopy with King vision ablade video laryngoscopy and direct laryngoscopy with Miller /Macintosh blade in pediatric patient.To assess the ease of intubation and associated hemodynamic responses to laryngoscopy with King vision ablade video laryngoscope as compared to direct laryngoscope in pediatric patients.
|