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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.

 
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