Insertion of a Transoesophageal Echocardiography Probe Using McGRATH

Cairo University (CU)

Status: Not yet enrolling

Conditions: Cardiac Surgery; Echocardiography, Transesophageal

Treatments: Device: McGRATH group; Device: Macintosh group

Study type: Interventional

Funder types: Other

Identifiers

NCT07346898

H-01-R-096

Details and patient eligibility

About

This randomized, parallel-group clinical trial compares McGRATH video laryngoscope-assisted versus Macintosh laryngoscope-assisted transoesophageal echocardiography (TEE) probe insertion in adult elective cardiac surgery patients. The primary aim is to compare incidence of pharyngeal mucosal injury during TEE probe insertion.

Full description

Transoesophageal echocardiography (TEE) is essential in cardiac anesthesia but TEE probe insertion can cause oropharyngeal mucosal injury and, rarely, esophageal perforation. In this prospective randomized study, adults (≥18 years, ASA II-III) undergoing elective cardiac surgery requiring intraoperative TEE will be randomized 1:1 to TEE probe insertion assisted by either the McGRATH MAC video laryngoscope (M group) or a conventional Macintosh laryngoscope (C group). After induction and tracheal intubation, TEE probe insertion will be attempted with the head in neutral position; the esophageal inlet visibility, number of attempts, total insertion time (seconds), intraoperative vital signs during insertion, and anesthesiologist satisfaction will be recorded. A blinded observer will assess pharyngeal mucosal injury (laceration and/or hematoma) immediately after probe removal. Sample size: 100 (50 per arm). An interim safety analysis will occur after 50 patients; a DSMB will review safety.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adults (male or female) aged ≥ 18 years
• ASA physical status II or III
• Scheduled for elective cardiac surgery under general anesthesia requiring intraoperative transoesophageal echocardiography
• Able to provide written informed consent

Exclusion criteria

• Dysphagia or sore throat
• Oropharyngeal infection
• Cervical spine pathology

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups

McGRATH group

Active Comparator group

Description:

TEE probe insertion assisted by McGRATH MAC video laryngoscope in an intubated patient under general anesthesia, head in neutral position.

Treatment:

Device: McGRATH group

Macintoch group

Active Comparator group

Description:

TEE probe insertion assisted by conventional Macintosh laryngoscope in an intubated patient under general anesthesia, head in neutral position.

Treatment:

Device: Macintosh group