| CTRI Number |
CTRI/2024/07/071399 [Registered on: 26/07/2024] Trial Registered Prospectively |
| Last Modified On: |
17/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective |
| Study Design |
Other |
|
Public Title of Study
|
To predict the difficulty in intubation during general anesthesia by neck circumference and thyromental distance (distancefrom the chin to the top of thyroid cartilage) in obese and overweight patient |
|
Scientific Title of Study
|
Assessment of difficult intubation based on neck circumference and thyromental distance ratio in obese and non-obese(overweight)patient; a prospective, observational study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Surendar N M |
| Designation |
MD anesthesia -Postgraduate |
| Affiliation |
Sri venkateswaraa medical college hospital and research center |
| Address |
No 13-A, Department of Anaesthesiology and critical care. Sri venkateswaraa medical college hospital and research center , pondy-villupuram main road, Ariyur,
Pondicherry
PONDICHERRY
605107
India |
| Phone |
9940463003 |
| Fax |
|
| Email |
surendharnora@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Chinthavali Sujatha |
| Designation |
Associate Professor |
| Affiliation |
Department of Anaesthesia Venkateshwaraa medical college hospital and research center, |
| Address |
No13-A, pondy-villupuram main road,Ariyur
Pondicherry
PONDICHERRY
605102
India |
| Phone |
8939012490 |
| Fax |
|
| Email |
Sujathachinthavali@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Chinthavali Sujatha |
| Designation |
Associate Professor |
| Affiliation |
Department of Anaesthesia Venkateshwaraa medical college hospital and research center, |
| Address |
No13-A, pondy-villupuram main road,Ariyur
Pondicherry
PONDICHERRY
605102
India |
| Phone |
8939012490 |
| Fax |
|
| Email |
Sujathachinthavali@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri venkateswaraa medical college hospital and research center, No 13-A pondy-villupuram main road,Ariyur, Puducherry, India 605102 |
|
|
Primary Sponsor
|
| Name |
Drsurendar |
| Address |
Sri Venkateshwaraa medical college hospital and research center, |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| DrSurendar |
Sri venkateswaraa medical college hospital and research center |
No 13-A, Department of Anaesthesiology OT complex, sri Venkateswaraa medical college hospital and research center
Pondicherry
PONDICHERRY |
9940463003
surendharnora@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sri venkateswaraa medical college hospital and research center |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 4||Measurement and Monitoring, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
Patient planned for elective Surgery under general anesthesia.
BMI range of 25 to 40 kg/m²(based on WHO classification of weight status)
Age18-45 years of age both sex
ASA 1 and 2
Hypertension
Diabetic mellitus
Bronchial asthma
COPD seizure disorder under control |
|
| ExclusionCriteria |
| Details |
1. Patien refusal
2. Pregnant women
3. Naso tracheal intubation
4. Airway pathology,Craniofacial abnormality
5. Restricted neck or tempero-mandibular joint movement
6. Morbid obesity (more than 40kg/m²)
7.Those requiring rapid sequence intubation (Hypothyroid)
8.Edentulous patient
9.Patient with neck swelling
10.Burns contracture in front of neck
11.Post tracheostomy patient
12.Past neck Surgery patient |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare neck circumference and thyromental distance ratio in obese and non obese patient as a predictor of difficult intubation. |
0 mins |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the intubation difficulty scale (IDS), to measure the time taken to intubate the case and to note the number of hypoxic episodes |
0 mins |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
28/07/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
28/07/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [surendharnora@gmail.com].
- For how long will this data be available start date provided 20-07-2024 and end date provided 28-02-2026?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
By measuring the difficult intubation predictor like neck circumference and thyromental distance ratio in obese and non obese, we can alleviate the unanticipated difficult intubation scenarios . Thereby reducing airway related complications. |