Use of McGrath Videolaryngoscope to Assist Transesophageal Echocardiography Probe Insertion in Intubated Patients

Study Overview
=================
Brief Summary
-----------------
The primary aim of this study is to investigate the difference in the first attempt and overall success rate of different techniques for insertion of transesophageal echocardiography. Secondary aim is to investigate the difference of the duration of insertion using the selected technique, complications during insertion such as oropharyngeal mucosal injury and hematoma.

Detailed Description
-----------------
Eighty adult patients, who received general anaesthesia for elective open heart surgeries that required transesophageal echocardiography insertion, will be randomized by means of a computer-generated randomization order into two groups: Conventional group (Group C), and videolaryngoscope group (group VL). Success rate of the selected technique (first attempt and overall), duration of insertion for selected technique, complications such as oropharyngeal mucosal injury and hematoma will be noted.

Official Title
-----------------
Use of McGrath Videolaryngoscope to Assist Transesophageal Echocardiography Probe Insertion in Intubated Patients: A Prospective Randomized Controlled Trial

Conditions
-----------------
Other Complications of Surgical and Medical Procedures

Intervention / Treatment
-----------------
* Device: conventional technique
* Device: videolaryngoscope technique


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who received general anaesthesia for open heart surgeries that required transesophageal echocardiography probe insertion Exclusion Criteria: patients younger than 18 years and older than 70 years oropharengeal infection esophageal injury and anatomic abnormalities known or predicted difficult airway

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: conventional technique<br>transesophageal echocardiography probe was inserted using a traditional blind insertion technique. | Device: conventional technique<br>* transesophageal echocardiography probe was inserted using a traditional blind insertion technique.<br>|
| Experimental: videolaryngoscope technique<br>transesophageal echocardiography probe was advanced into esophagus under direct vision using videolaryngoscope | Device: videolaryngoscope technique<br>* transesophageal echocardiography probe was advanced into esophagus under direct vision using videolaryngoscope<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| difference in the first attempt and overall success rate | investigate the difference in the first attempt and overall success rate (with percentage) of different techniques for insertion of transesophageal echocardiography probe. | participants will be followed from the beginning of the transesophageal echocardiography probe insertion through the mouth to the confirmation of successful insertion (10 minutes) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| difference of the duration of insertion and complications during insertion | investigate the difference of the duration of insertion (in seconds) using the selected technique and complications (with number and percentage) during insertion such as oropharyngeal mucosal injury and hematoma. | participants will be followed for the duration of intraoperative period and postoperative 8 hours. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
transesophageal echocardiography, videolaryngoscope, oropharyngeal injury