| CTRI Number |
CTRI/2024/04/065945 [Registered on: 18/04/2024] Trial Registered Prospectively |
| Last Modified On: |
27/06/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Transesophageal echocardiography probe insertion with different methods and change in vital parameters |
|
Scientific Title of Study
|
Comparison of flexible videoendoscope, video laryngoscopy assisted or blind
transoesophageal echocardiography probe insertion on hemodynamic parameters in adults
undergoing cardiac surgery: A randomized controlled 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 |
Devishree Das |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS, Bhubaneswar |
| Address |
Department Of Anaesthesia,
AIIMS, Bhubaneswar,
Sijua, Patrapada,Bhubaneswar,Odisha
Khordha
ORISSA
751019
India |
| Phone |
8895299296 |
| Fax |
|
| Email |
devishreedas111@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Devishree Das |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS, Bhubaneswar |
| Address |
Department Of Anaesthesia,
AIIMS, Bhubaneswar,
Sijua, Patrapada,Bhubaneswar,Odisha
Khordha
ORISSA
751019
India |
| Phone |
8895299296 |
| Fax |
|
| Email |
devishreedas111@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Devishree Das |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS, Bhubaneswar |
| Address |
Department Of Anaesthesia,
AIIMS, Bhubaneswar,
Sijua, Patrapada,Bhubaneswar,Odisha
Khordha
ORISSA
751019
India |
| Phone |
8895299296 |
| Fax |
|
| Email |
devishreedas111@gmail.com |
|
|
Source of Monetary or Material Support
|
| AIIMS, Bhubaneswar,
Sijua, Patrapada,Bhubaneswar,Odisha, INDIA, 751019 |
|
|
Primary Sponsor
|
| Name |
AIIMS Bhubaneswar |
| Address |
AIIMS, Bhubaneswar,
Sijua, Patrapada,Bhubaneswar,Odisha, India, 751019 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Devishree Das |
AIIMS, Bhubaneswar |
Department Of Anaesthesia,
AIIMS, Bhubaneswar,
Sijua, Patrapada,Bhubaneswar,Odisha,751019
Khordha
ORISSA |
8895299296
devishreedas111@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, All India Institute of Medical Sciences, Bhubaneswar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I259||Chronic ischemic heart disease, unspecified, (2) ICD-10 Condition: I083||Combined rheumatic disorders of mitral, aortic and tricuspid valves, (3) ICD-10 Condition: I062||Rheumatic aortic stenosis with insufficiency, (4) ICD-10 Condition: I051||Rheumatic mitral insufficiency, (5) ICD-10 Condition: I050||Rheumatic mitral stenosis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Blind insertion technique |
TEE probe will be inserted blindly |
| Intervention |
Flexible videoendoscope technique |
TEE insertion will be facilitated by flexible
videoendoscope |
| Intervention |
Video laryngoscope assisted
technique |
TEE probe will be inserted with the
help of C-MAC video laryngoscope |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
undergoing elective cardiac surgery and requiring TEE evaluation will be included. |
|
| ExclusionCriteria |
| Details |
Patients with known or anticipated difficult airway or requiring 2 attempt of for intubation, nasal pathology or deviated nasal septum and those in whom the TEE probe cannot be used will be excluded from the study. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| TEE probe insertion success |
success at first attempt |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| time to insertion |
at the time of insertion |
| number of attempts required to successfully insert the TEE probe |
at the time of insertion |
| hemodynamic variation |
5 minutes of TEE probe insertion |
| operator satisfaction |
at the time of insertion |
| incidence of complications related to TEE probe insertion |
at the end of surgery |
|
|
Target Sample Size
|
Total Sample Size="135"
Sample Size from India="135"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="150" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
13/05/2024 |
| Date of Study Completion (India) |
05/03/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Transoesophageal echocardiography (TEE) is an invaluable tool in the cardiac anesthesia armamentarium and used to assess cardiac structure and function. Requirement of TEE is critical in every step during perioperative period, beginning from the preoperative confirmation of diagnosis, surgical decision making, assessment of ventricular function and ensuring adequate postoperative repair. Conventionally, TEE probe is inserted blindly. However, repeated attempt of conventional blind insertion technique may cause oropharyngeal laceration, oesophageal tear, gastric injury leading to gastrointestinal bleeding, and dysphagia. The incidence of major complications associated with TEE probe is very low around 0.08% (1:1300 examination), but the probability of death is high, almost >40% if any such major complication occurs. Hence, sometimes jaw thrust, and/or conventional laryngoscope is used to aid the insertion of the TEE probe. Recently, the use of video laryngoscopy for insertion of the TEE probe has found to be helpful in decreasing the incidence of trauma. Though video laryngoscope is a useful technique compared to blind insertion, the incidence of hemodynamic perturbations may be similar to jaw thrust manoeuvre, and conventional laryngoscope assisted insertion. Flexible videoendoscope has emerged as an important component of difficult airway equipment. No previous studies have used flexible videoendoscope assisted insertion of the TEE probe. It may be possible that use of a flexible videoendoscope for assisting TEE probe insertion may provide better performance characteristics as compared to a video laryngoscope in terms of a wider field of view, allowing both hands of the operator for oral manipulation and TEE probe insertion along with less hemodynamic perturbations; but with a similar first pass success rate. |