| CTRI Number |
CTRI/2023/09/057545 [Registered on: 13/09/2023] Trial Registered Prospectively |
| Last Modified On: |
10/09/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Screening |
| Study Design |
Randomized Factorial Trial |
|
Public Title of Study
|
study comparing two ultrasonographic techniques in overweight and obese patients for confirmation of endotracheal intubation |
|
Scientific Title of Study
|
Randomized study between tracheal and pleural ultrasonography comparing time for confirmation of correct placement of endotracheal tube in overweight and Obese patients. |
| Trial Acronym |
Comparison between two ultrasonography techniques for confirmation of endotracheal intubation |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrShweta Konnur |
| Designation |
Associate Professor |
| Affiliation |
Bharati hospital and research centre |
| Address |
Major Operation Theatre complex,3rd floor,Bharati Hospital,Katraj.
Dhankawadi, Katraj,Pune.
Pune
MAHARASHTRA
411043
India |
| Phone |
9823890369 |
| Fax |
|
| Email |
shwetajm81@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrShweta Konnur |
| Designation |
Associate Professor |
| Affiliation |
Bharati hospital |
| Address |
Anesthesia department
Bharati hospital,
Katraj,Pune.
Bharati Hospital and Research centre, Dhankawadi, Katraj,Pune.
Pune
MAHARASHTRA
411043
India |
| Phone |
9823890369 |
| Fax |
|
| Email |
shwetajm81@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Neha Wakhare |
| Designation |
JRII Anaesthesia |
| Affiliation |
Bharati hospital |
| Address |
Major operation Theatre complex,Bharati Hospital,Katraj,Pune
Bharati Hospital and Research centre, Dhankawadi, Katraj,Pune.
Pune
MAHARASHTRA
411043
India |
| Phone |
9823890369 |
| Fax |
|
| Email |
dr.neha.wakhare@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Bharati hospital |
| Address |
Bharati Hospital and Research centre Dhankawadi Katraj,Pune. |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Bharati Hospital |
Bharati Hospital and Research centre Dhankawadi Katraj,Pune. |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DrNeha Wakhare |
Bharati Hospital and Research centre |
Department of Anaesthesia,
Major Operation theater, 3rd floor bharati hospital
Pune
MAHARASHTRA |
9730780139
dr.neha.wakhare@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Bharati vidyapeeth medical college,Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Overweight and obese |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Tracheal and Pkeural Ultrasonography in overweight and obese class |
Timing for each will be noted |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA Iand II Patients
Patients posted foe elective surgeries under general anaesthesia requiring endotracheal intubation.
Overweight(BMI 25 to 29.9)Obese class I(BMI 30 to 34.9)and Class II(BMI 35 to 39.9) |
|
| ExclusionCriteria |
| Details |
Patients refusal
Patients with mouth opening less than 2 fingers
Patients with Cervical spine disorders
Patients with abnormal airway anatomy |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To see if tracheal sonography is faster and effective than pleural sonography |
Outcome will be regularly assessed after 6 wks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare time required by tracheal and pleural ultrasonography with time of auscultation for endotracheal tube placement |
time in seconds |
|
|
Target Sample Size
|
Total Sample Size="64"
Sample Size from India="64"
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
|
Phase 1/ Phase 2 |
|
Date of First Enrollment (India)
|
30/09/2023 |
| 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="2"
Months="6"
Days="15" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Title-Randomized study between Tracheal and Pleural Ultrasonography comparing time for confirmation of correct placement of endotracheal tube in obese and overweight patients Aim-To compare time required by tracheal and pleural ultrasonography techniques for confirmation of correct placement of endotracheal tube in overweight and obese patients. Primary Objective-To compare time required by Tracheal and Pleural ultrasonography techniques for confirmation of correct placement of endotracheal tube in overweight and obese patients Study to be conducted in bharati hospital duration of study is from June2022 to January 2024 |