| CTRI Number |
CTRI/2024/07/071383 [Registered on: 26/07/2024] Trial Registered Prospectively |
| Last Modified On: |
03/08/2024 |
| 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 New Technique |
|
Scientific Title of Study
|
Use of Videolaryngoscope for Transesophageal Probe Insertion in Pediatric Patients Undergoing Cardiac Surgery |
| Trial Acronym |
TEE |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Guriqbal Singh |
| Designation |
Assistant Professor Department of Cardiac Anaesthesia |
| Affiliation |
U. N. Mehta Institute of Cardiology and Research Centre |
| Address |
U. N. Mehta Institute of Cardiology and Research Centre, Civil Hospital Campus,Asarwa Ahmedabad-380016,Gujarat,india
Ahmadabad
GUJARAT
380016
India |
| Phone |
918238018244 |
| Fax |
|
| Email |
guriqbal6@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Guriqbal Singh |
| Designation |
Assistant Professor Department of Cardiac Anaesthesia |
| Affiliation |
U. N. Mehta Institute of Cardiology and Research Centre |
| Address |
U. N. Mehta Institute of Cardiology and Research Centre, Civil Hospital Campus,Asarwa Ahmedabad-380016,Gujarat,india
Ahmadabad
GUJARAT
380016
India |
| Phone |
918238018244 |
| Fax |
|
| Email |
guriqbal6@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Guriqbal Singh |
| Designation |
Assistant Professor Department of Cardiac Anaesthesia |
| Affiliation |
U. N. Mehta Institute of Cardiology and Research Centre |
| Address |
U. N. Mehta Institute of Cardiology and Research Centre, Civil Hospital Campus,Asarwa Ahmedabad-380016,Gujarat,india
Ahmadabad
GUJARAT
380016
India |
| Phone |
918238018244 |
| Fax |
|
| Email |
guriqbal6@gmail.com |
|
|
Source of Monetary or Material Support
|
| U. N. Mehta Institute of Cardiology and Research Centre, Ahmedabad (India)-380016 |
|
|
Primary Sponsor
|
| Name |
U N Mehta Institute of Cardiology and Research Centre |
| Address |
U. N. Mehta Institute of Cardiology and Research Centre, Ahmedabad (India)-380016 |
| 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 |
| Dr Guriqbal Singh |
U. N. Mehta Institute of Cardiology and Research Centre |
Department of Cardiac Anaesthesia
U. N. Mehta Institute of Cardiology and Research Centre
Civil Hospital Campus
Asarwa
Ahmadabad
GUJARAT |
8238018244
guriqbal6@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee UNMICRC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I52||Other heart disorders in diseasesclassified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Non-videolaryngoscope |
VL scope would not be used for TEE probe insertion and TEE probe would be inserted by conventional blind technique.
Duration-3 months |
| Intervention |
videolaryngoscope |
Group VL (videolaryngoscope group): VL scope would be used for TEE probe insertion.
VLScope would be inserted intraorally, and after viewing esophageal inlet, TEE probe would be advanced into esophagus under direct vision.
TEE probe will removed after performing cardiac evaluation at the end of surgery and probe tip will be examined for presence or absence of blood.
After TEE removal, all patients will be examined for pharyngeal injury, hematoma and sites of injury will be documented.
Duration - 3 months |
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
Patients of age 2-10 years
weight > 5kg
|
|
| ExclusionCriteria |
| Details |
Contraindications for TEE insertion
Deranged coagulation parameters
difficult tracheal intubation
patients with sore throat, oropharyngeal infection and sore throat.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To study the incidence of oropharyngeal injury, which is defined as blood at the tip of TEE probe at the end of surgery and/or evidence of injury on VL examination at the end of surgery.
|
After removal of TEE probe at the time of completion of surgery. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
number of attempts required for successful TEE probe insertion & relationship between esophageal inlet & larynx.
|
Number of attempts required for TEE probe insertion: time point- After induction of anaesthesia after insertion of TEE probe.
Relationship between esophageal inlet & larynx:
Time point: During insertion of TEE probe after induction of anaesthesia only in VL group. |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "120"
Final Enrollment numbers achieved (India)="100" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
09/08/2024 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
30/11/2023 |
|
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
|
- After careful assessment and written informed consent, patients will be included into study. On arrival, a peripheral venous cannula will be inserted. Standard monitoring include, 5 lead ECG, CVP, pulse oximetry, invasive blood pressure monitoring. General anaesthesia will be induced as per institutional protocol. All patients will be intubated using conventional rigid laryngoscope with appropriately-sized endotracheal tube. After tracheal intubation, oropharyngeal secretions will be suctioned. If there would be blood staining or trauma due to intubation would be diagnosed, patient will be excluded from the study. Patients will be randomised into two groups. Group C (conventional group): TEE probe would be inserted blindly. Group VL (videolaryngoscope group): VL scope would be used for TEE probe insertion. VLScope would be inserted intraorally, and after viewing esophageal inlet, TEE probe would be advanced into esophagus under direct vision. TEE probe will removed after performing cardiac evaluation at the end of surgery and probe tip will be examined for presence or absence of blood. After TEE removal, all patients will be examined for pharyngeal injury, hematoma and sites of injury will be documented. Number of attempts for TEE probe insertion will be documented. Relationship between esophageal inlet and larynx will be documented with a photograph. Number of attempts required for TEE probe insertion and injuries in both the groups will be compared.
|