Clinical trial NCT04980976: C-MAC Videolaryngoscope for Insertion of a Transesophageal Echocardiography Probe in ICU Patients
Official title: C-MAC Videolaryngoscope for Insertion of a Transesophageal Echocardiography Probe in ICU Patients. A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Critical Illness
Keywords: transesophageal
echocardiography
videolaryngoscope;
Lead sponsor: Hospital Clinico Universitario de Santiago
Sponsor class: OTHER
First posted: 2021-07-28
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Difference in the first attempt success rate (percentage)
timeFrame: 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:
measure: Difference in the overall success rate (percentage)
timeFrame: 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)
measure: Difference in the incidence of complications (percentage)
timeFrame: 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.
measure: Difference in the duration of insertion
timeFrame: 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.
Other outcomes:
Locations:
city: Santiago de Compostela
country: Spain
facility: Manuel Taboada
state: La Coruña
Study officials:
affiliation: University Clinical Hospital of Santiago de Compostela
name: Manuel Taboada
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.