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

NCT04980976 | Completed

• 1 other identifier: CEIG 2020/375
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Critical Illness

Keywords

transesophageal; echocardiography; videolaryngoscope;

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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)

• 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.

• 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.

Study Arms (2)

Conventional blind insertion technique.

ACTIVE COMPARATOR

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

Device: Blind insertion technique

C-MAC videolaryngoscope insertion technique

EXPERIMENTAL

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

Interventions

Blind insertion technique DEVICE

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

Conventional blind insertion technique.

C-MAC videolaryngoscope insertion technique DEVICE

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

C-MAC videolaryngoscope insertion technique

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ICU intubated patients that require transesophageal echocardiography probe insertion

You may not qualify if:

• patients younger than 18 years and older than 85 years
• oropharengeal infection
• esophageal injury and anatomic abnormalities
• Consent refusal for participating in the trial.

Sponsors & Collaborators

• Hospital Clinico Universitario de Santiago: lead

Study Sites (1)

Manuel Taboada

Santiago de Compostela, La Coruña, 15701, Spain

Location

Related Publications (5)

• 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.

  PMID: 26575010 BACKGROUND

• 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.

  PMID: 27498268 BACKGROUND

• 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.

  PMID: 33430768 BACKGROUND

• 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.

  PMID: 25543216 BACKGROUND

• Taboada M, Carinena A, Estany-Gestal A, Iglesias-Alvarez D, Veiras S, Martinez A, Eiras M, De Miguel M, Selas S, Martinez-Monzonis A, Pereira P, Bastos-Fernandez M, Gonzalez-Salvado V, Alvarez-Barrado M, Ferreiroa E, Caruezo V, Costa J, Naveira A, Otero P, Adrio B, Martinez-Cereijo JM, Fernandez A, Gonzalez-Juanatey JR, Alvarez J, Seoane-Pillado T. Videolaryngoscope versus conventional technique for insertion of a transesophageal echocardiography probe in intubated ICU patients (VIDLARECO trial): A randomized clinical trial. Anaesth Crit Care Pain Med. 2024 Apr;43(2):101346. doi: 10.1016/j.accpm.2024.101346. Epub 2024 Jan 24.

  PMID: 38278357 DERIVED

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Manuel Taboada

  University Clinical Hospital of Santiago de Compostela

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: After TEE insertion, the pharyngeal mucosa will be evaluated with de C-MAC videolaryngoscope by an anesthesiologist who were blinded to the study
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: July 21, 2021
• First Posted: July 28, 2021
• Study Start: August 19, 2021
• Primary Completion: May 1, 2023
• Study Completion: May 1, 2023
• Last Updated: September 21, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: When available: With publication
• Access Criteria: Researchers whose proposed use of the data has been approved Types of analyses: For scientific purpose

Locations

ES (1)