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

Hospital Clinico Universitario de Santiago

Status: Completed

Conditions: Critical Illness

Treatments: Device: C-MAC videolaryngoscope insertion technique; Device: Blind insertion technique

Study type: Interventional

Funder types: Other

Identifiers

NCT04980976

CEIG 2020/375

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 100 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 2 patient groups

Conventional blind insertion technique.

Active Comparator group

Description:

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

Treatment:

Device: Blind insertion technique

C-MAC videolaryngoscope insertion technique

Experimental group

Description:

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

Treatment:

Device: C-MAC videolaryngoscope insertion technique