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
| Type | Name | Description |
|---|---|---|
| DEVICE | McGRATH group | McGRATH video laryngoscope used to assist TEE probe insertion in an intubated patient under general anesthesia |
| DEVICE | Macintosh group | Macintosh 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.