Insertion of a Transoesophageal Echocardiography Probe Using McGRATH

N/ANot Yet RecruitingNCT07346898

Cairo University100 enrolled

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.

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

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

100

Conditions

Echocardiography, Transesophageal Cardiac Surgery

Interventions

McGRATH groupDEVICE

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

Macintosh groupDEVICE

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Prince Sultan Cardiac Center

Riyadh, Riyadh Region, Saudi Arabia

Outcomes

Primary Outcomes

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.

Time frame: Immediately after TEE probe removal (intraoperatively)

Secondary Outcomes

Visibility of the oesophageal inlet

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

Time frame: 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.

Time frame: 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

Time frame: During the intraoperative TEE probe insertion procedure

Central Contacts

Ahmed Abdalwahab, MD

CONTACT

00966533437590 aabdalwahab@pscc.med.sa

Data from ClinicalTrials.gov

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