Cardiac Surgery, Echocardiography, Transesophageal
Conditions
Keywords
cardiac anaesthesia, Transesophageal Echocardiography, pharyngeal mucosal injury
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.
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
DEVICEMcGRATH group
McGRATH video laryngoscope used to assist TEE probe insertion in an intubated patient under general anesthesia
DEVICEMacintosh group
Macintosh laryngoscope used to assist TEE probe insertion in an intubated patient under general anesthesia
Sponsors
Cairo University
Prince Sultan Cardiac Center, Adult Cardiology Department.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of pharyngeal mucosal injury | 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
| Measure | Time frame | Description |
|---|---|---|
| Visibility of the oesophageal inlet | During TEE probe insertion (first insertion attempt, intraoperatively) | Categorical - "Visible" vs "Not visible" as recorded by the operator. |
| Duration of TEE probe insertion (seconds) | During the intraoperative TEE probe insertion procedure | Total duration in seconds from mouth opening to successful esophageal insertion, summed across all insertion attempts. |
| Number of insertion attempts | During the intraoperative TEE probe insertion procedure | Count of discrete insertions into the mouth until successful esophageal passage or study-defined stop |
Countries
Saudi Arabia
Contacts
CONTACTAhmed Abdalwahab, MD
Outcome results
None listed