| CTRI Number |
CTRI/2019/04/018705 [Registered on: 24/04/2019] Trial Registered Prospectively |
| Last Modified On: |
21/04/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of video laryngoscope with conventional laryngoscope for tracheal intubation in pediatric patients |
|
Scientific Title of Study
|
Comparison of Patwashah-i video laryngoscope with Macintosh laryngoscope for tracheal intubation in pediatric patients-a prospective randomized controlled clinical 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 Apeksha Patwa |
| Designation |
Assistant Professor |
| Affiliation |
ssg hospital |
| Address |
Department of anesthesiology,ssg hospital,jail road,vadodara
Vadodara
GUJARAT
390001
India |
| Phone |
|
| Fax |
|
| Email |
patwaapeksha@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Apeksha Patwa |
| Designation |
Assistant Professor |
| Affiliation |
ssg hospital |
| Address |
Department of anesthesiology,ssg hospital,jail road,vadodara
GUJARAT
390001
India |
| Phone |
|
| Fax |
|
| Email |
patwaapeksha@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Apeksha Patwa |
| Designation |
Assistant Professor |
| Affiliation |
ssg hospital |
| Address |
Department of anesthesiology,ssg hospital,jail road,vadodara
GUJARAT
390001
India |
| Phone |
|
| Fax |
|
| Email |
patwaapeksha@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
government medical college vadodara |
| Address |
government medical college ssg hospital vadodara |
| 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 |
| Dr Pratik Prajapati |
SSG Hospital |
department of anaesthesiology,2nd floor-new surgical block,ssg hospital,vadodara
Vadodara
GUJARAT |
9601167480
dr.pratik13@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IECHR,Medical College,Baroda |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N433||Hydrocele, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Macintosh conventional laryngoscope |
Macintosh conventional laryngoscope with pediatric blades of size No. 2,3 |
| Intervention |
video laryngoscope |
Patwashah-i video laryngoscope with a non-channeled pediatric blade with a 7" inch screen monitor. |
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
-Patients posted for elective surgery under general anesthesia
-age:2-12 years
-either sex
-ASA I&II
-mouth opening>20mm |
|
| ExclusionCriteria |
| Details |
-Patients with difficult airway
(malampatti,receding mandible,others)
-Abnormal airway anatomy
-URTI (upper respiratory tract infection)
-Preexisting laryngeal or tracheal pathology
-Patient’s parents/guardian not willing for participation |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Glottic exposure time |
at the time of intubation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| cormack and lehane grading |
at the time of intubation
grade I,II,III,IV |
| Intubation time |
at the time of intubation |
| number of attempts |
at the time of intubation |
| optimization maneuvers |
BURP(backward,upward,rightward pressure) |
| vital parameters(pulse,mean map,spo2,etco2) |
baseline,before induction of anaesthesia,1 min after induction,before video laryngoscopy,1 min after video laryngoscopy,5 mins after video laryngoscopy,10 mins after video laryngoscopy,15 mins after video laryngoscopy |
| complications-oropharyngeal trauma |
none,trace,heavy |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
25/04/2019 |
| 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
|
none |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Glottic exposure time will be shorter and overall success rate will be more compared to conventional macintosh laryngoscope
hypthesis- Patwashah video laryngoscope will be equal or superior to macintosh laryngoscope |