C-MAC Videolaryngoscope for Insertion of a Transesophageal Echocardiography Probe in ICU Patients

Study Overview
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Brief Summary
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Transesophageal echocardiography (TEE) is commonly used in operating room (cardiac surgery), as well as in other critical care settings. A recent meta-analysis including only three randomized studies demonstrated that the use of a videolaryngoscope for transesophageal echocardiography probe insertion in anesthetized patients undergoing open cardiac surgery was associated with a significant reduction in the number of attempts. insertion and complications rate, compared with blind insertion or a laryngoscope-assisted insertion. ICU patients are usually intubated, with multiple complications, requiring high doses of catecholamines, and with frequent coagulation disorders. Many of these patients, during their stay in the ICU, require a transesophageal echocardiogram. On multiple occasions, due to the critical situation of the patients, due to edema, and coagulation alteration, the placement of the echocardiography probe can be difficult, leading to complications, such as gastric bleeding or lesions in the oropharyngeal mucosa. To avoid complications during the insertion of the TEE tube, the investigators consider it necessary to introduce it in the fewest possible attempts. The primary aim of the present study was to compare the success rate of TEE probe insertion at the first attempt betweenn the C-MAC videolaryngoscope assisted insertion and the blind insertion technique. The secondary aim was to compared differences between the 2 groups in the incidence of complications ( oropharyngeal mucosal injury, hematoma, ….), overall success rate, the number of insertion attempts, and the duration of insertions.

Detailed Description
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One hundred intubated ICU adult patients that require transesophageal echocardiography insertion, will be randomized by means of a computer-generated randomization order into two groups: Conventional group (Group Blind), and videolaryngoscope group (group C-MAC). Success rate of the selected technique (first attempt), overall success rate, number of attempts, complications, and duration of insertion for technique will be noted.

Official Title
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C-MAC Videolaryngoscope for Insertion of a Transesophageal Echocardiography Probe in ICU Patients. A Randomized Controlled Trial

Conditions
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Critical Illness

Intervention / Treatment
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* Device: Blind insertion technique
* Device: C-MAC videolaryngoscope insertion technique


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ICU intubated patients that require transesophageal echocardiography probe insertion Exclusion Criteria: patients younger than 18 years and older than 85 years oropharengeal infection esophageal injury and anatomic abnormalities Consent refusal for participating in the trial.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Conventional blind insertion technique.<br>Transesophageal echocardiography probe will be inserted using a conventional blind insertion technique. | Device: Blind insertion technique<br>* Transesophageal echocardiography probe will be inserted using a conventional blind insertion technique.<br>|
| Experimental: C-MAC videolaryngoscope insertion technique<br>Transesophageal echocardiography probe will be inserted using a C-MAC videolaryngoscope insertion technique to advance into esophagus under direct vision. | Device: C-MAC videolaryngoscope insertion technique<br>* Transesophageal echocardiography probe will be inserted using a C-MAC videolaryngoscope insertion technique<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in the first attempt success rate (percentage) | To compare the difference in the first attempt (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 or three attempts) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in the overall success rate (percentage) | To compare the difference overall success rate (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 or three attempts) | 
| Difference in the incidence of complications (percentage) | To compare the difference in complications 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 or three attempts) and in the next 24 hours. | 
| Difference in the duration of insertion | To compare the duration of different techniques for insertion of intransesophageal 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 or three attempts) and in the next 24 hour and in the next 24 hours. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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transesophageal, echocardiography, videolaryngoscope;