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

Not Applicable

Completed

• Conditions: Critical Illness
• Interventions: Device: Blind insertion technique; Device: C-MAC videolaryngoscope insertion technique

• Registration Number: NCT04980976
• Lead Sponsor: Hospital Clinico Universitario de Santiago

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2021-07-21
• Study First Submitted QC: 2021-07-27
• Study First Posted: 2021-07-28
• Study Start: 2021-08-19
• Primary Completion: 2023-05-01
• Study Completion: 2023-05-01
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-20
• Last Update Posted: 2023-09-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional blind insertion technique.	Blind insertion technique	Transesophageal echocardiography probe will be inserted using a conventional blind insertion technique.
C-MAC videolaryngoscope 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.

Primary Outcome Measures

Name	Time	Method
Difference in the first attempt success rate (percentage)	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)	To compare the difference in the first attempt (percentage) of different techniques for insertion of transesophageal echocardiography probe.

Secondary Outcome Measures

Name	Time	Method
Difference in the duration of insertion	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.	To compare the duration of different techniques for insertion of intransesophageal echocardiography probe.
Difference in the overall success rate (percentage)	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)	To compare the difference overall success rate (percentage) of different techniques for insertion of transesophageal echocardiography probe.
Difference in the incidence of complications (percentage)	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.	To compare the difference in complications of different techniques for insertion of transesophageal echocardiography probe.

Trial Locations

Locations (1)

Manuel Taboada; 🇪🇸 Santiago de Compostela, La Coruña, Spain