| CTRI Number |
CTRI/2024/06/068734 [Registered on: 11/06/2024] Trial Registered Prospectively |
| Last Modified On: |
09/06/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
prospective |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of changing head to left position in children while putting scope TO see better view while putting scope |
|
Scientific Title of Study
|
Effect of left head rotation on glottic view as assessed with Macintosh scope 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 |
Departement of Anaesthesia
6th tower, 1st floor
A block
Ernakulam
KERALA
682041
India |
| Phone |
09947419155 |
| Fax |
|
| Email |
gayatrisreekumar31@gmail.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
A block
Ernakulam
KERALA
682041
India |
| Phone |
9447464652 |
| Fax |
04842802020 |
| Email |
sunilrajan@aims.amrita.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Gayathri sreekumar |
| Designation |
Senior resident |
| Affiliation |
Amrita Institute of medical sciences |
| Address |
Departement of Anaesthesia
6th Tower , 1st Floor
A BLOCK
Ernakulam
KERALA
682041
India |
| Phone |
09947419155 |
| Fax |
|
| Email |
gayatrisreekumar31@gmail.com |
|
|
Source of Monetary or Material Support
|
| Amrita Institute of Medical Sciences
Department of Anaesthesia
6th Tower, 1st floor
A block
Ponekkara, Edapally
PIN CODE-682041 |
|
|
Primary Sponsor
|
| Name |
Amrita Institute of Medical Sciences |
| Address |
Departement of Anaesthesia
6th tower, 1st floor
A block
pincode-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 |
Departement of Anaesthesia 6th Tower 1st Floor
Ernakulam
KERALA |
09947419155
gayatrisreekumar31@gmail.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 |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
8.00 Year(s) |
| Gender |
Both |
| Details |
1) paediatric patients 1 to 8 years
2) patients requiring general anaesthesia
|
|
| ExclusionCriteria |
| Details |
1)restricted mouth opening
2) oral, pharyngeal tumours |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Effect of left head rotation on glottic view as assessed with Macintosh scope 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, incidence of trauma
6) hemodynamic changes during 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
|
The primary aim to is to see whether when we rotate head to left side to 45 degree in paediatric patients will increase the glottic view as using Macintosh laryngoscope . The secondary outcome is to see ease of intubation, number of attempts, any trauma, any haemodynamic instability during induction and after induction , requirement of bougie for intubation and whether head needs to be turned back to classic sniffing position to intubate |