Insertion of a Transoesophageal Echocardiography Probe Using McGRATH
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: McGRATH group, Macintosh group.
- Who it may be relevant to
- Registry conditions: Echocardiography, Transesophageal, Cardiac Surgery. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Saudi Arabia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Insertion of a Transoesophageal Echocardiography Probe Using McGRATH Video Laryngoscope in Cardiac Surgery Patients: Randomized Controlled Study
Overview
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.
Interventions
- 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
Primary outcome measures
- Incidence of pharyngeal mucosal injury [Time frame: Immediately after TEE probe removal (intraoperatively)]
Secondary outcome measures (3)
- Visibility of the oesophageal inlet [Time frame: During TEE probe insertion (first insertion attempt, intraoperatively)]
- Duration of TEE probe insertion (seconds) [Time frame: During the intraoperative TEE probe insertion procedure]
- Number of insertion attempts [Time frame: During the intraoperative TEE probe insertion procedure]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Prevention
Study locations
Saudi Arabia · 1 center
- Prince Sultan Cardiac Center — Riyadh
Identifiers
NCT: NCT07346898 · H-01-R-096