| CTRI Number |
CTRI/2024/01/062158 [Registered on: 31/01/2024] Trial Registered Prospectively |
| Last Modified On: |
25/01/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
prospective pre and post study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of changing head position sideways to see if any improvement in view while putting airway tube. |
|
Scientific Title of Study
|
Effect of left head rotation on glottic view as assessed with POGO score while using C MAC video laryngoscope D blade |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Gayathri sreekumar |
| Designation |
Senior resident |
| Affiliation |
Amrita Institute of medical sciences |
| Address |
Sreekumar bhavan,lakasserry
Chengannur
Alappuzha
KERALA
689121
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 |
Department of Anaesthesia,
A BLOCK, 6TH TOWER, 1ST FLOOR,
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 |
Sreekumar bhavan, lakassery
chengannur
Alappuzha
KERALA
689121
India |
| Phone |
09947419155 |
| Fax |
|
| Email |
gayatrisreekumar31@gmail.com |
|
|
Source of Monetary or Material Support
|
| Amrita institute of medical sciences |
|
|
Primary Sponsor
|
| Name |
Amrita institute of medical sciences |
| Address |
Department of Anaesthesia,
A BLOCK, 6TH TOWER 1ST FLOOR, Ponekkara P O. |
| 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,
A BLOCK, 6TH TOWER 1ST FLOOR, Ponekkara P O.
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: C039||Malignant neoplasm of gum, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients requiring general anesthesia with nasal intubation
a.Patients aged 18-70 years,
b.American Society of Anesthesiologists physical status (ASA PS) 1 to 3,
c.Patients with Mallapati score of 3 and 4
d.Restricted tongue protrusion or neck extension |
|
| ExclusionCriteria |
| Details |
i.Patients with POGO sore of 100%
ii.Nasal, oral or oropharyngeal tumours
iii.Carcinoma larynx
iv.Postoperative cases with soft tissue flaps in tongue
v. post radiotherapy patients with neck rigidity |
|
|
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. |
after induction |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
The ease of nasal intubation in left head rotation position
2) number of attempts and the time taken for intubation
3) requirement of external neck manipulation ,cuff inflation or Magill’s forceps for intubation
4) whether head is required to be turned back to classic position due to difficulty in intubation,
5)incidence of trauma
6) hemodynamic changes during intubation will also be assessed. |
from start of induction till end of surgery |
|
|
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)
|
04/02/2024 |
| 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 objective of the study is to see whether rotating head to 45degree left will improve the glottic view as assessed with POGO score while using C mac Blade D video laryngoscope. The secondary objectives of the study include mutiple objectives like ease of nasal intubation in left lateral position ,number of attempts,duration of laryngoscopy, use of external neck manipulation /Magills forceps/ cuff inflation incidence of trauma while intubation , haemodynamic changes during intubation will also be assessed.The patients included in the study are patients needing nasal intubation during the surgery. exclusuion criteria includes patients who received post radiotherapy, nasal/oral or oropharyngeal cancers, carcinoma larynx. |