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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Cardiac Surgery; Echocardiography, Transesophageal
• Intervention / Treatment: Device: McGRATH group; Device: Macintosh group

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.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ahmed Abdalwahab, MD; Phone Number: 00966533437590; Email: aabdalwahab@pscc.med.sa

Study Locations

• Saudi Arabia
  • Riyadh Region
    • Riyadh, Riyadh Region, Saudi Arabia, 12623
      • Prince Sultan Cardiac Center
      • Contact: Ahmed Galal, MD; Phone Number: 00966530799761; Email: aalsherinny@pscc.med.sa

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: McGRATH group; TEE probe insertion assisted by McGRATH MAC video laryngoscope in an intubated patient under general anesthesia, head in neutral position.	Device: McGRATH group; McGRATH video laryngoscope used to assist TEE probe insertion in an intubated patient under general anesthesia; Other Names: M group
Active Comparator: Macintoch group; TEE probe insertion assisted by conventional Macintosh laryngoscope in an intubated patient under general anesthesia, head in neutral position.	Device: Macintosh group; Macintosh laryngoscope used to assist TEE probe insertion in an intubated patient under general anesthesia; Other Names: C group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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)

Secondary Outcome Measures

Outcome Measure	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)	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

Collaborators and Investigators

• Sponsor: Cairo University
• Collaborators: Prince Sultan Cardiac Center, Adult Cardiology Department.

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2026
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: December 19, 2025
• First Submitted That Met QC Criteria: January 8, 2026
• First Posted (Estimated): January 16, 2026

Study Record Updates

• Last Update Posted (Estimated): January 16, 2026
• Last Update Submitted That Met QC Criteria: January 8, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: cardiac anaesthesia, Transesophageal Echocardiography; pharyngeal mucosal injury
• Other Study ID Numbers: H-01-R-096

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No