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

September 20, 2023 updated by: Manuel Taboada Muñiz, Hospital Clinico Universitario de Santiago

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Spain
    • La Coruña
      • Santiago de Compostela, La Coruña, Spain, 15701
        • Manuel Taboada

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Conventional blind insertion technique.
Transesophageal echocardiography probe will be inserted using a conventional blind insertion technique.
Device: Blind insertion technique
Transesophageal echocardiography probe will be inserted using a conventional blind insertion technique.
Experimental: 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.
Device: C-MAC videolaryngoscope insertion technique
Transesophageal echocardiography probe will be inserted using a C-MAC videolaryngoscope insertion technique

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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)
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.
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)
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.
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
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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Clinico Universitario de Santiago

Investigators

  • Principal Investigator: Manuel Taboada, University Clinical Hospital of Santiago de Compostela

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 19, 2021

Primary Completion (Actual)

May 1, 2023

Study Completion (Actual)

May 1, 2023

Study Registration Dates

First Submitted

July 21, 2021

First Submitted That Met QC Criteria

July 27, 2021

First Posted (Actual)

July 28, 2021

Study Record Updates

Last Update Posted (Actual)

September 21, 2023

Last Update Submitted That Met QC Criteria

September 20, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CEIG 2020/375

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data types: Deidentified participant data How to access data: Requests must be sent to manutabo@yahoo.es When available: With publication Additional Information Who can access the data: Researchers whose proposed use of the data has been approved T ypes of analyses: For scientific purpose Mechanisms of data availability: With investigator support

IPD Sharing Time Frame

When available: With publication

IPD Sharing Access Criteria

Researchers whose proposed use of the data has been approved Types of analyses: For scientific purpose

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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