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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-19

Study Completion Date

2023-05-01

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.

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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.

Conditions

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Critical Illness

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

After TEE insertion, the pharyngeal mucosa will be evaluated with de C-MAC videolaryngoscope by an anesthesiologist who were blinded to the study

Study Groups

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Conventional blind insertion technique.

Transesophageal echocardiography probe will be inserted using a conventional blind insertion technique.

Group Type ACTIVE_COMPARATOR

Blind insertion technique

Intervention Type DEVICE

Transesophageal echocardiography probe will be inserted using a conventional blind insertion technique.

C-MAC videolaryngoscope insertion technique

Transesophageal echocardiography probe will be inserted using a C-MAC videolaryngoscope insertion technique to advance into esophagus under direct vision.

Group Type EXPERIMENTAL

C-MAC videolaryngoscope insertion technique

Intervention Type DEVICE

Transesophageal echocardiography probe will be inserted using a C-MAC videolaryngoscope insertion technique

Interventions

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Blind insertion technique

Transesophageal echocardiography probe will be inserted using a conventional blind insertion technique.

Intervention Type DEVICE

C-MAC videolaryngoscope insertion technique

Transesophageal echocardiography probe will be inserted using a C-MAC videolaryngoscope insertion technique

Intervention Type DEVICE

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No