Clinical Trials Directory

Trials / Not Yet Recruiting

Not Yet RecruitingNCT07346898

Insertion of a Transoesophageal Echocardiography Probe Using McGRATH

Insertion of a Transoesophageal Echocardiography Probe Using McGRATH Video Laryngoscope in Cardiac Surgery Patients: Randomized Controlled Study

Status
Not Yet Recruiting
Phase
N/A
Study type
Interventional
Enrollment
100 (estimated)
Sponsor
Cairo University · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

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.

Detailed 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.

Conditions

Interventions

TypeNameDescription
DEVICEMcGRATH groupMcGRATH video laryngoscope used to assist TEE probe insertion in an intubated patient under general anesthesia
DEVICEMacintosh groupMacintosh laryngoscope used to assist TEE probe insertion in an intubated patient under general anesthesia

Timeline

Start date
2026-01-01
Primary completion
2026-06-01
Completion
2026-06-30
First posted
2026-01-16
Last updated
2026-01-16

Locations

1 site across 1 country: Saudi Arabia

Source: ClinicalTrials.gov record NCT07346898. Inclusion in this directory is not an endorsement.