| CTRI Number |
CTRI/2024/06/068644 [Registered on: 10/06/2024] Trial Registered Prospectively |
| Last Modified On: |
10/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
propspective |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of changing head to left position will improve the view while using in built video scope |
|
Scientific Title of Study
|
Effect of left head rotation on glottic view as assessed with POGO score while using C MAC video laryngoscope D in paediatric 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 |
Gayathri Sreekumar |
| Designation |
Senior resident |
| Affiliation |
Amrita Institute of Medical Sciences |
| Address |
Department of Anaesthesia
Tower 6 1st floor A block
AIMS Ponekkara PO
Ernakulam
KERALA
682041
India |
| Phone |
9947419155 |
| Fax |
04842802020 |
| Email |
gayatrisk_cgnr@hotmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sunil Rajan |
| Designation |
Professor |
| Affiliation |
Amrita Institute of medical sciences |
| Address |
Departement of anaesthesia
6th tower 1st floor
Ernakulam
KERALA
682041
India |
| Phone |
9447464652 |
| Fax |
04842802020 |
| Email |
sunilrajan@aims.amrita.edu |
|
Details of Contact Person
Public Query
|
| Name |
Gayathri Sreekumar |
| Designation |
Senior resident |
| Affiliation |
Amrita Institute of medical sciences |
| Address |
Departement of Anaesthesia
6th Tower , 1st floor
AIMS Ponekkara PO
Ernakulam
KERALA
682041
India |
| Phone |
9947419155 |
| Fax |
04842802020 |
| Email |
gayatrisk_cgnr@hotmail.com |
|
|
Source of Monetary or Material Support
|
| Amrita institute of medical sciences
Department of Anaesthesia
6th Tower 1st Floor
Ponekkara, Ernakulam
pincode 682041 |
|
|
Primary Sponsor
|
| Name |
Amrita Institute of Medical Sciences |
| Address |
Department of Anaesthesia
6th tower 1st floor
Ponekkara, Ernakulam
Pin code-682041 |
| 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 Gayathri Sreekumar |
Amrita institute of medical sciences |
Department of Anaesthesia
Tower 6 1st floor A block
Ernakulam
KERALA |
09947419155
gayatrisk_cgnr@hotmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics committee of Amrita school of Medicine |
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 |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
8.00 Year(s) |
| Gender |
Both |
| Details |
1) pediatric patients aged 1 to 8 years
2) ML grading 3 or 4 |
|
| ExclusionCriteria |
| Details |
1) Emergency surgeries
2) oral oe nasal tumours |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess whether rotating head to the left side to 45 degrees in supine position improves glottic view as assessed with POGO score during indirect laryngoscopy using C MAC video laryngoscope D blade under general anaesthesia as compared with the classic sniffing position in paediatric patients. |
After induction |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1)The ease of intubation in left head rotation position
2)Number of attempts
3)Time taken for intubation, 4)Requirement of bougie for intubation
5)Whether head is required to be turned back to classic position due to difficulty in intubation
6)Incidence of trauma 7)Hemodynamic changes during & after intubation will also be assessed |
After induction |
|
|
Target Sample Size
|
Total Sample Size="35"
Sample Size from India="35"
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)
|
24/06/2024 |
| 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="0"
Months="6"
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
|
Primary objective is to see whether rotating head to left lateral position will increase the glottic view while assessing with cmac videolaryngoscope D blade using POGO score assessment in paediatric patients. secondary objectives include ease of intubation, attempts at intubation , whether bougie needed for intubation , whether heads needs to be turned back to classic position to intubate, any trauma during intubation and haemodynamic chnages during intubation . |