Insertion of a Transoesophageal Echocardiography Probe Using McGRATH

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-31

Study Completion Date

2026-06-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Echocardiography, Transesophageal Cardiac Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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McGRATH group

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

Group Type ACTIVE_COMPARATOR

McGRATH group

Intervention Type DEVICE

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

Macintoch group

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

Group Type ACTIVE_COMPARATOR

Macintosh group

Intervention Type DEVICE

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

Interventions

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McGRATH group

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

Intervention Type DEVICE

Macintosh group

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

Intervention Type DEVICE

Other Intervention Names

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M group C group

Eligibility Criteria

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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