| CTRI Number |
CTRI/2024/06/069182 [Registered on: 19/06/2024] Trial Registered Prospectively |
| Last Modified On: |
17/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Surgical/Anesthesia
Screening
Other (Specify) |
| Study Design |
Other |
|
Public Title of Study
|
An observational study Predicting factors associated With difficult insertion Of TEE probe in adult patients Undergoing cardiac surgery. |
|
Scientific Title of Study
|
An observational study predicting factors associated with difficulty in insertion of transesophageal echocardiography probe in adult patients undergoing cardiac surgery. |
| 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 Ipshita Garg |
| Designation |
Junior Resident |
| Affiliation |
DR. D. Y. PATIL MEDICAL COLLEGE PUNE |
| Address |
Dr. D. Y. Patil Medical College Hospital and Research Centre Sant Tukaram Nagar Pimpri Pune 411018
Department of Anaesthesiology, Ground Floor, Old building, Dr. D. Y. Patil Medical College and Research Centre, Pimpri, Chinchwad
Pune
MAHARASHTRA
411018
India |
| Phone |
9811036698 |
| Fax |
|
| Email |
ipshitag15@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shahbaz Hasnain |
| Designation |
Professor |
| Affiliation |
DR D. Y. PATIL MEDICAL COLLEGE PUNE |
| Address |
Dr. D. Y. Patil Medical College Hospital and Research Centre Sant Tukaram Nagar Pimpri Pune 411018
Department of Anaesthesiology, Ground Floor, Old building, Dr. D. Y. Patil Medical College and Research Centre, Pimpri, Chinchwad
Pune
MAHARASHTRA
411018
India |
| Phone |
9764621253 |
| Fax |
|
| Email |
shahbazhsnn@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ipshita Garg |
| Designation |
Junior Resident |
| Affiliation |
|
| Address |
Dr. D. Y. Patil Medical College Hospital and Research Centre Sant Tukaram Nagar Pimpri Pune 411018
Department of Anaesthesiology, Ground Floor, Old building, Dr. D. Y. Patil Medical College and Research Centre, Pimpri, Chinchwad
Pune
MAHARASHTRA
411018
India |
| Phone |
9811036698 |
| Fax |
|
| Email |
ipshitag15@gmail.com |
|
|
Source of Monetary or Material Support
|
| Hitech OT 5th floor, Dr. D. Y. Patil Medical College Hospital and Research Centre Sant Tukaram Nagar, Pimpri, Pune, Maharashtra, India, 411018 |
|
|
Primary Sponsor
|
| Name |
Dr Ipshita Garg |
| Address |
Dr. D. Y. Patil Medical College Hospital And Research Centre Sant Tukaram Nagar Pimpri Pune |
| 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 |
| Dr Ipshita Garg |
Dr. D. Y. Patil Medical College and Hospital Pimpri, Pune |
Minor OT, Ground floor, Hi-tech building Pune MAHARASHTRA
Pune
MAHARASHTRA |
9811036698
ipshitag15@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Sub Committee Dr. D. Y. Patil Medical College Hospital and Research Centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Asa 2 and Asa 3 patients |
| Patients |
(1) ICD-10 Condition: I252||Old myocardial infarction, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Transesophageal Echocardiography Probe |
The shaft of the TEE probe Will be held in the right hand And the handle in the left Hand. The shaft of the probe Will be anteflexed to make it Curved like an endotracheal Tube and it will be introduced Into the esophagus of the Patient. Factors causing difficulty in insertion of the probe will be responsible for the number of attempts required to insert the probe. once inserted, the procedure will take 10 minutes to get completed and then the probe will be removed. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Asa 2 and Asa 3 fit patients. Patients that are haemodynamically stable and giving written informed consent. |
|
| ExclusionCriteria |
| Details |
Patients with restricted mouth opening and or neck extension. Patients with absolute or relative contraindications for transesophageal echocardiography probe placement. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To identify the predictive Factors for difficult Transesophageal Echocardiography probe Insertion in adult patients Undergoing cardiac surgery. |
It will be assessed instantly during the procedureand recorded. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To calculate the percentage of Difficulty contributed by the Airway factors such as modified Mallampatti classification, modified Cormack-Lehane grading, & Thyromental distance of the Patient in transesophageal Echocardiography probe Insertion. |
It will be assessed instantly when the procedure is done & the outcomes will be recorded. |
|
|
Target Sample Size
|
Total Sample Size="119"
Sample Size from India="119"
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)
|
30/06/2024 |
| 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
|
It is an observational study. The aim of this study is to identify the predictive factors for difficult transesophageal echocardiography probe insertion in adult patients undergoing cardiac surgery. To predict this we will be considering demographic factors such as gender and body mass index and airway factors like modified mallampatti classification, cormack-lehane grading and thyromental distance of the patient. We will also be assessing the manoeuvre that will be used in case of a difficult transesophageal echocardiography probe insertion.
|