Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07346898

Insertion of a Transoesophageal Echocardiography Probe Using McGRATH

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Echocardiography, Transesophageal Cardiac Surgery

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

McGRATH group

Device

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

Other names: M group

Macintosh group

Device

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

Other names: C group

Primary outcomes

  1. Incidence of pharyngeal mucosal injury

    Time frame: Immediately after TEE probe removal (intraoperatively)

    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.

Secondary outcomes

  1. Visibility of the oesophageal inlet

    Time frame: During TEE probe insertion (first insertion attempt, intraoperatively)

    Categorical - "Visible" vs "Not visible" as recorded by the operator.

  2. Duration of TEE probe insertion (seconds)

    Time frame: During the intraoperative TEE probe insertion procedure

    Total duration in seconds from mouth opening to successful esophageal insertion, summed across all insertion attempts.

  3. Number of insertion attempts

    Time frame: During the intraoperative TEE probe insertion procedure

    Count of discrete insertions into the mouth until successful esophageal passage or study-defined stop

Study contacts

Contact information is provided by the study sponsor or research team.

Ahmed Abdalwahab, MD

CONTACT

[email protected]

00966533437590

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Collaborators

  • Prince Sultan Cardiac Center, Adult Cardiology Department.

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jan 16, 2026
Registry last updated
Jan 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.