| CTRI Number |
CTRI/2025/03/081859 [Registered on: 06/03/2025] Trial Registered Prospectively |
| Last Modified On: |
18/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective observational |
| Study Design |
Other |
|
Public Title of Study
|
To compare factors predicting difficulty in insertion of Echocardiography probe into Oesophagus and the methods used for insertion intraoperatively |
|
Scientific Title of Study
|
Transesophageal Echocardiography Probe Insertion Correlation Between Difficulty Predictors And Methods Of Insertion 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 |
Daniel Jonathan Roy |
| Designation |
Post Graduate Resident |
| Affiliation |
Christian Medical College Vellore |
| Address |
Department of Anaesthesiology Christian Medical College
Vellore
Vellore TAMIL NADU 632004 India |
| Phone |
9500843687 |
| Fax |
|
| Email |
danieljonathanroy@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Balaji Kuppuswamy |
| Designation |
Professor |
| Affiliation |
Christian Medical College Vellore |
| Address |
Department of Anaesthesiology Christian Medical College
Vellore
Vellore TAMIL NADU 632004 India |
| Phone |
7406777127 |
| Fax |
|
| Email |
balooswamy@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Balaji Kuppuswamy |
| Designation |
Professor |
| Affiliation |
Christian Medical College Vellore |
| Address |
Department of Anaesthesiology Christian Medical College
Vellore
Vellore TAMIL NADU 632004 India |
| Phone |
7406777127 |
| Fax |
|
| Email |
balooswamy@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institutional Fluid grant
Christian Medical College
Vellore 632004
Tamil Nadu
India |
|
|
Primary Sponsor
|
| Name |
Christian Medical College and Hospital Vellore |
| Address |
Department of Anasthesia, Christian Medical College and Hospital, Vellore- 632004 |
| Type of Sponsor |
Private medical college |
|
|
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 DANIEL JONATHAN ROY |
CHRISTIAN MEDICAL COLLEGE |
Cardiothoracic Operation Theatres Room no 1,2,3
Department of Anaesthesia
Christian Medical College
Ranipet
Vellore TAMIL NADU |
9500843687
danieljonathanroy@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Review Board and Ethics Committee of CMC Vellore |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I39||Endocarditis and heart valve disorders in diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients undergoing elective Adult Cardiothoracic surgeries such as Open Heart (Valvular),Coronary Artery Bypass Graft Surgeries. |
|
| ExclusionCriteria |
| Details |
Patients with Esophageal stricture,Esophageal tumor,Active Upper GI Bleed.
Patients with restricted mouth opening or severe limitation in neck extension.
Patients with carotid artery diseases(In view of Plaque embolization during reverse Sellicks manuever)
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To correlate the difficulty predictors of Transesophageal probe insertion and Techniques used intraoperatively |
1 hour |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Correlate with Intubation difficulty Score
2.To assess oropharyngeal injury with Videolaryngoscopy after extubation. |
1 hour |
|
|
Target Sample Size
|
Total Sample Size="600" Sample Size from India="600"
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)
|
20/03/2025 |
| 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="0" 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
|
Transesophageal echocardiography is a critically important cardiovascular imaging modality. The proximity of the esophagus to much of the heart and great vessels makes it an excellent ultrasonic window so that TEE provides additional and more accurate information than transthoracic echocardiography TTE. TEE has proven utility in a number of clinical areas including the operating room, intensive care unit, interventional laboratory, and outpatient setting. TEE has become an essential imaging tool for cardiac surgeons, anesthesiologists, cardiac interventionalists, and clinical cardiologists. TEE examination in the outpatient setting is usually done for diagnostic purposes by cardiologists facilitated with local aerosol sprays or viscous gels to anesthetize the pharynx. For intraprocedural TEE examination in the operating room and catheterization laboratory where anesthesiologists are involved, probe insertion is carried out under general anesthesia with endotracheal intubation. The TEE probe resembles a flexible endoscope that consists of probe tip with acoustic lens, shaft, handle and a connector to attach to the echo machine. Even though TEE examination is a semi invasive procedure, it is not without complications which are related mainly to the probe insertion. The list of complications varies from minor injury to major bleeding. However, the complications of TEE examination in the hands of trained physicians are rare, if the test is performed diligently and patiently. Different techniques of TEE probe insertion have been described such as blind insertion through the midline with the mandible lifted, jaw thrust maneuver, reverse Sellicks maneuver, rigid laryngoscope assistance or optical guided insertion and video laryngoscope. Factors that predict difficult endotracheal intubation included age, sex, BMI, Modified Mallampati Criteria and Modified Cormack Lehane grade would be helpful in the evaluation of difficult TEE probe placement. We propose to do a prospective observational study aimed at identifying the predictive factors for difficult insertion of TEE probe in anesthetized adult patients undergoing cardiac surgery and to correlate the predictive factors with the maneuver required to insert the TEE probe. |