| CTRI Number |
CTRI/2023/06/054261 [Registered on: 21/06/2023] Trial Registered Prospectively |
| Last Modified On: |
21/06/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
To see if rotating the neck to left side during laryngoscopy improves the chance of successful intubation |
|
Scientific Title of Study
|
Left head rotation as an aid for successful intubation in patients with difficult airway: A prospective observational 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 Roopali Phulli |
| Designation |
Fellow Onco anaesthesia |
| Affiliation |
Rajiv Gandhi Cancer Institute and Reasearch Centre |
| Address |
Department of Anaesthesia
RGCIRC, Rohini, delhi
West
DELHI
110085
India |
| Phone |
8850819472 |
| Fax |
|
| Email |
roopali2693@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mamta Dubey |
| Designation |
Senior consultant |
| Affiliation |
Rajiv Gandhi Cancer Institute and Reasearch Centre |
| Address |
department of anesthesia
RGCIRC, Rohini, delhi
West
DELHI
110085
India |
| Phone |
8850819472 |
| Fax |
|
| Email |
dubey.mamta@rgcirc.org |
|
Details of Contact Person
Public Query
|
| Name |
Dr Roopali Phulli |
| Designation |
Fellow Onco anaesthesia |
| Affiliation |
Rajiv Gandhi Cancer Institute and Reasearch Centre |
| Address |
department of anaesthesia
RGCIRC, Rohini, delhi
West
DELHI
110085
India |
| Phone |
8850819472 |
| Fax |
|
| Email |
roopali2693@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
rajiv gandhi cancer institute and research centre |
| Address |
department of anaesthesia |
| Type of Sponsor |
Research institution |
|
|
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 Roopali Phulli |
Rajiv Gandhi Cancer Institute |
department of anaesthesia
North West
DELHI |
8850819472
roopali2693@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| RAJIV GANDHI CANCER INSTITUTE AND RESEARCH CENTRE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C55||Malignant neoplasm of uterus, partunspecified, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
ASA Grade(I-III)
Inter-incisor gap >3.5 cm
All patients requiring oral endotracheal intubation with McIntosch laryngoscope blade for general anaesthesia.
|
|
| ExclusionCriteria |
| Details |
Patients with restricted neck mobility or unstable spine.
Patients requiring Awake Fibreoptic intubation.
Patients requiring rapid sequence intubation.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Left head rotation manoeuvre is likely to improve the glottic visualisation and intubation condition thus a viable alternative for difficult endotracheal intubation.
|
2months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| TO ASSESS IF THERE IS ANY IMPROVEMENT IN IDS SCORE WITH LATERAL HEAD ROTATION |
2months |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
30/06/2023 |
| 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="4"
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
|
Sniffing position(neck flexion and head extension )is a gold standard position for laryngoscopy and intubation. At times may not be sufficient to intubate a patient with difficult airway due to high Cormack Lehane grade(CL grade). In an anaesthetised patient, the tongue becomes flaccid, as a result tends to fall back, obstructing the airway patency. By left head rotation, we attempt to resolve this issue by utilizing gravity to our benefit. Left head rotation along with laryngoscopy shifts the tongue to the left side and gravity aids to further displace it on the left dependent side hence improving the laryngoscopic view. Fibreoptic bronchoscope , videolaryngoscope etc are used in case one encounters an unanticipated difficult airway, but there availability and cost are limitations in resource poor areas, thus we plan to use a simple maneuver of left head rotation for improving intubating conditions by improving cormack lehane grading.
|