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

Critical Illness Clinical Trial

— VIDLARECO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04980976
• Other study ID #: CEIG 2020/375
• Status: Completed
• Phase: N/A
• Start date: August 19, 2021
• Est. completion date: May 1, 2023

Study information

• Verified date: September 2023
• Source: Hospital Clinico Universitario de Santiago
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: May 1, 2023
• Est. primary completion date: May 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Critical Illness

Intervention

Device:
• Blind insertion technique
Transesophageal echocardiography probe will be inserted using a conventional blind insertion technique.
• C-MAC videolaryngoscope insertion technique
Transesophageal echocardiography probe will be inserted using a C-MAC videolaryngoscope insertion technique

Locations

Country	Name	City	State
Spain	Manuel Taboada	Santiago de Compostela	La Coruña

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Clinico Universitario de Santiago

Country where clinical trial is conducted

Spain, 

References & Publications (4)

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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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	Difference in the overall success rate (percentage)	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)
Secondary	Difference in the incidence of complications (percentage)	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.
Secondary	Difference in the duration of insertion	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.