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| Name | Class |
|---|---|
| Prince Sultan Cardiac Center, Adult Cardiology Department. | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| McGRATH group | Active Comparator | TEE probe insertion assisted by McGRATH MAC video laryngoscope in an intubated patient under general anesthesia, head in neutral position. |
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| Macintoch group | Active Comparator | TEE probe insertion assisted by conventional Macintosh laryngoscope in an intubated patient under general anesthesia, head in neutral position. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| McGRATH group | Device | McGRATH video laryngoscope used to assist TEE probe insertion in an intubated patient under general anesthesia |
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| Measure | Description | Time Frame |
|---|---|---|
| Incidence of pharyngeal mucosal injury | Presence of laceration and/or hematoma in the posterior pharyngeal wall, postcricoid area, lateral/medial walls of the piriform sinuses, or the esophageal inlet as observed by a blinded observer after removal of the TEE probe. | Immediately after TEE probe removal (intraoperatively) |
| Measure | Description | Time Frame |
|---|---|---|
| Visibility of the oesophageal inlet | Categorical - "Visible" vs "Not visible" as recorded by the operator. | During TEE probe insertion (first insertion attempt, intraoperatively) |
| Duration of TEE probe insertion (seconds) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ahmed Abdalwahab, MD | Contact | 00966533437590 | aabdalwahab@pscc.med.sa |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Prince Sultan Cardiac Center | Riyadh | Riyadh Region | 12623 | Saudi Arabia |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 7, 2026 | Jan 8, 2026 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 7, 2026 | Jan 8, 2026 | ICF_001.pdf |
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Prospective, randomized controlled study This is a Parallel-Group Randomized Controlled Trial (RCT) - each participant is randomized into one of two groups, receives only that intervention, and outcomes are compared between groups. There's no crossover, no sequential intervention; both groups proceed in parallel.
Number of study arms:
There are two arms:
Macintosh group (C group) - TEE probe insertion assisted by a conventional Macintosh laryngoscope.
McGRATH group (M group) - TEE probe insertion assisted by a McGRATH video laryngoscope.
Each arm receives a distinct intervention, and the primary endpoint (incidence of pharyngeal mucosal injury) will be compared between them.
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| Macintosh group | Device | Macintosh laryngoscope used to assist TEE probe insertion in an intubated patient under general anesthesia |
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Total duration in seconds from mouth opening to successful esophageal insertion, summed across all insertion attempts.
| During the intraoperative TEE probe insertion procedure |
| Number of insertion attempts | Count of discrete insertions into the mouth until successful esophageal passage or study-defined stop | During the intraoperative TEE probe insertion procedure |