C-MAC Videolaryngoscope for Insertion of a Transesophageal Echocardiography Probe in ICU Patients (VIDLARECO)
Primary Purpose
Critical Illness
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Blind insertion technique
C-MAC videolaryngoscope insertion technique
Sponsored by
About this trial
This is an interventional prevention trial for Critical Illness focused on measuring transesophageal, echocardiography, videolaryngoscope;
Eligibility Criteria
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.
Sites / Locations
- Manuel Taboada
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Conventional blind insertion technique.
C-MAC videolaryngoscope insertion technique
Arm Description
Transesophageal echocardiography probe will be inserted using a conventional blind insertion technique.
Transesophageal echocardiography probe will be inserted using a C-MAC videolaryngoscope insertion technique to advance into esophagus under direct vision.
Outcomes
Primary Outcome Measures
Difference in the first attempt success rate (percentage)
To compare the difference in the first attempt (percentage) of different techniques for insertion of transesophageal echocardiography probe.
Secondary Outcome Measures
Difference in the overall success rate (percentage)
To compare the difference overall success rate (percentage) of different techniques for insertion of transesophageal echocardiography probe.
Difference in the incidence of complications (percentage)
To compare the difference in complications of different techniques for insertion of transesophageal echocardiography probe.
Difference in the duration of insertion
To compare the duration of different techniques for insertion of intransesophageal echocardiography probe.
Full Information
NCT ID
NCT04980976
First Posted
July 21, 2021
Last Updated
September 20, 2023
Sponsor
Hospital Clinico Universitario de Santiago
1. Study Identification
Unique Protocol Identification Number
NCT04980976
Brief Title
C-MAC Videolaryngoscope for Insertion of a Transesophageal Echocardiography Probe in ICU Patients
Acronym
VIDLARECO
Official Title
C-MAC Videolaryngoscope for Insertion of a Transesophageal Echocardiography Probe in ICU Patients. A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
August 19, 2021 (Actual)
Primary Completion Date
May 1, 2023 (Actual)
Study Completion Date
May 1, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Clinico Universitario de Santiago
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Critical Illness
Keywords
transesophageal, echocardiography, videolaryngoscope;
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Masking Description
After TEE insertion, the pharyngeal mucosa will be evaluated with de C-MAC videolaryngoscope by an anesthesiologist who were blinded to the study
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Conventional blind insertion technique.
Arm Type
Active Comparator
Arm Description
Transesophageal echocardiography probe will be inserted using a conventional blind insertion technique.
Arm Title
C-MAC videolaryngoscope insertion technique
Arm Type
Experimental
Arm Description
Transesophageal echocardiography probe will be inserted using a C-MAC videolaryngoscope insertion technique to advance into esophagus under direct vision.
Intervention Type
Device
Intervention Name(s)
Blind insertion technique
Intervention Description
Transesophageal echocardiography probe will be inserted using a conventional blind insertion technique.
Intervention Type
Device
Intervention Name(s)
C-MAC videolaryngoscope insertion technique
Intervention Description
Transesophageal echocardiography probe will be inserted using a C-MAC videolaryngoscope insertion technique
Primary Outcome Measure Information:
Title
Difference in the first attempt success rate (percentage)
Description
To compare the difference in the first attempt (percentage) of different techniques for insertion of transesophageal echocardiography probe.
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)
Secondary Outcome Measure Information:
Title
Difference in the overall success rate (percentage)
Description
To compare the difference overall success rate (percentage) of different techniques for insertion of transesophageal echocardiography probe.
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)
Title
Difference in the incidence of complications (percentage)
Description
To compare the difference in complications of different techniques for insertion of transesophageal echocardiography probe.
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.
Title
Difference in the duration of insertion
Description
To compare the duration of different techniques for insertion of intransesophageal echocardiography probe.
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Manuel Taboada
Organizational Affiliation
University Clinical Hospital of Santiago de Compostela
Official's Role
Principal Investigator
Facility Information:
Facility Name
Manuel Taboada
City
Santiago de Compostela
State/Province
La Coruña
ZIP/Postal Code
15701
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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
Citations:
PubMed Identifier
26575010
Citation
Ishida T, Kiuchi C, Sekiguchi T, Tsujimoto T, Kawamata M. McGRATH MAC video laryngoscope for insertion of a transoesophageal echocardiography probe: A randomised controlled trial. Eur J Anaesthesiol. 2016 Apr;33(4):263-8. doi: 10.1097/EJA.0000000000000367.
Results Reference
background
PubMed Identifier
27498268
Citation
Kavrut Ozturk N, Kavakli AS. Use of McGrath MAC Videolaryngoscope to Assist Transesophageal Echocardiography Probe Insertion in Intubated Patients. J Cardiothorac Vasc Anesth. 2017 Feb;31(1):191-196. doi: 10.1053/j.jvca.2016.03.150. Epub 2016 Mar 31.
Results Reference
background
PubMed Identifier
33430768
Citation
Kumamoto T, Tashima K, Hiraoka C, Ikuta Y, Yamamoto T. McGRATH MAC video laryngoscope assistance during transesophageal echocardiography may reduce the risk of complications: a manikin study. BMC Anesthesiol. 2021 Jan 11;21(1):14. doi: 10.1186/s12871-020-01231-3.
Results Reference
background
PubMed Identifier
25543216
Citation
Kim MK, Park SW, Sim Y, Lee JW. Use of a McGrath Videolaryngoscope to assist transesophageal echocardiography probe insertion in anesthetized patients. J Cardiothorac Vasc Anesth. 2015 Apr;29(2):e16-7. doi: 10.1053/j.jvca.2014.09.007. Epub 2014 Dec 24. No abstract available.
Results Reference
background
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C-MAC Videolaryngoscope for Insertion of a Transesophageal Echocardiography Probe in ICU Patients
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