| CTRI Number |
CTRI/2024/01/061638 [Registered on: 19/01/2024] Trial Registered Prospectively |
| Last Modified On: |
16/01/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A study to compare easiness of placement of endotracheal tube using video laryngoscopy between sniffing position where neck flexed with cervical extension and ramped position where patients upper body and head aligned in slightly upper position compared to lower body , in obese patients. |
|
Scientific Title of Study
|
A comparative study between ramped and sniffing position in video laryngoscopy guided tracheal intubation in obese 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 |
Dr STEFFI THOMAS |
| Designation |
Post Graduate |
| Affiliation |
kerala university of medical sciences |
| Address |
department of Anaesthesia , Amala institute of medical sciences , thrissur
Thrissur
KERALA
680555
India |
| Phone |
8138884322 |
| Fax |
|
| Email |
drpegasus88@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr DERLIN THOMAS |
| Designation |
Associate Professor |
| Affiliation |
kerala university of medical sciences |
| Address |
department of Anaesthesiology,
Amala institute of medical sciences,
Thrissur
Thrissur
KERALA
680555
India |
| Phone |
9447768944 |
| Fax |
|
| Email |
derlin.t@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr DERLIN THOMAS |
| Designation |
Associate Professor |
| Affiliation |
kerala university of medical sciences |
| Address |
department of Anaesthesiology,
Amala institute of medical sciences,
Thrissur
Thrissur
KERALA
680555
India |
| Phone |
9447768944 |
| Fax |
|
| Email |
derlin.t@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesia , Amala Institute Of Medical Sciences,
amalanagar , SH 69 , Thrissur - 680555 |
|
|
Primary Sponsor
|
| Name |
Dr Steffi Thomas |
| Address |
tharayil house, erumathala p o, keezhumadu, aluva |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Derlin Thomas |
associate professor, Department of anaesthesia , amala institute of medical sciences, thrissur |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Steffi Thomas |
Amala institute of medical sciences, Thrissur |
department of Anaesthesia , Amala institute of medical sciences, amalanagar , SH69, Thrissur - 680555
Thrissur
KERALA |
8138884322
drpegasus88@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics committee, Amala institute of medical sciences, thrissur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E668||Other obesity, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
nil |
nil |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1.ASA 1,2 and 3
2.BMI greater than 30 Kg per sq metre |
|
| ExclusionCriteria |
| Details |
1.history of difficult intubation and cervical spine defect,
2.history of previous head and neck surgeries,
3.any risk factors present for pulmonary aspiration,
4.rapid sequence intubation,
5.anticipated difficult airway requiring fibreoptic bronchoscopy |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Comparison of total intubation time and laryngoscopic view in sniffing and ramped position in video laryngocopy guided intubation in obese |
18 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Factors associated with intubation failure |
18 months |
| Assess complication in sniffing and ramped position in video laryngoscopy guided intubation in obese |
18 months |
|
|
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)
|
01/02/2024 |
| 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="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 - NO
|
|
Brief Summary
|
This study is a longitudinal , comparing easiness in video laryngoscopic tracheal intubation between sniffing and ramping position in obese patients in 80 patients that will be conducted in Amala institute of medical sciences, thrissur. The primary outcome is to compare the intubation time and laryngoscopic view in both positions. The second outcome is to find factors assosciated with intubation failure. |