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Completed

NCT Number: NCT04980976

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

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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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Manuel Taboada

Santiago de Compostela, La Coruña, 15701, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Blind insertion technique

Device

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

C-MAC videolaryngoscope insertion technique

Device

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

Primary outcomes

  1. Difference in the first attempt success rate (percentage)

    Time frame: 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 outcomes

  1. Difference in the overall success rate (percentage)

    Time frame: 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.

  2. Difference in the incidence of complications (percentage)

    Time frame: 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.

  3. Difference in the duration of insertion

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Hospital Clinico Universitario de Santiago

Other

Registry information

Official study title

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

Acronym: VIDLARECO

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Jul 28, 2021
Registry last updated
Sep 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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