Insertion of a Transoesophageal Echocardiography Probe Using McGRATH

NCT07346898 | Not Yet Recruiting DMC

• 1 other identifier: H-01-R-096
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cardiac Surgery; Echocardiography, Transesophageal

Keywords

cardiac anaesthesia, Transesophageal Echocardiography; pharyngeal mucosal injury

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Visibility of the oesophageal inlet

  During TEE probe insertion (first insertion attempt, intraoperatively)

• Duration of TEE probe insertion (seconds)

  During the intraoperative TEE probe insertion procedure

• Number of insertion attempts

  During the intraoperative TEE probe insertion procedure

Study Arms (2)

McGRATH group

ACTIVE COMPARATOR

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

Device: McGRATH group

Macintoch group

ACTIVE COMPARATOR

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

Device: Macintosh group

Interventions

McGRATH group DEVICE

McGRATH video laryngoscope used to assist TEE probe insertion in an intubated patient under general anesthesia

Also known as: M group

McGRATH group

Macintosh group DEVICE

Macintosh laryngoscope used to assist TEE probe insertion in an intubated patient under general anesthesia

Also known as: C group

Macintoch group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Cairo University: lead
• Prince Sultan Cardiac Center, Adult Cardiology Department.: collaborator

Study Sites (1)

Prince Sultan Cardiac Center

Riyadh, Riyadh Region, 12623, Saudi Arabia

Location

Central Study Contacts

Ahmed Abdalwahab, MD

CONTACT

00966533437590; aabdalwahab@pscc.med.sa

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of anaesthesia

Model Details: 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.

Study Record Dates

• First Submitted: December 19, 2025
• First Posted: January 16, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: January 16, 2026

Record last verified: 2026-01

Locations

SA (1)