Echocardiography, TransesophagealNCT07346898
Insertion of a Transoesophageal Echocardiography Probe Using McGRATH
A study testing McGRATH group and Macintosh group in people with Echocardiography, Transesophageal and Cardiac Surgery, run by Cairo University at 1 site in Saudi Arabia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Echocardiography, Transesophageal, Cardiac Surgery
- What is being tested?
- McGRATH group and Macintosh group
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- Jan 2026to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Dysphagia or sore throat
- Oropharyngeal infection
- Cervical spine pathology
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Saudi Arabia1 site
Prince Sultan Cardiac Center
Riyadh, Riyadh Region, 12623
Ahmed Galal, MD, 00966530799761, aalsherinny@pscc.med.sa
About this study
Official title: Insertion of a Transoesophageal Echocardiography Probe Using McGRATH Video Laryngoscope in Cardiac Surgery Patients: Randomized Controlled Study
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.
Read the 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.
- Conditions
- Echocardiography, Transesophageal, Cardiac Surgery
- Being tested
- McGRATH group, Macintosh group
- Keywords
- cardiac anaesthesia, Transesophageal Echocardiography, pharyngeal mucosal injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
McGRATH groupDevice
Also called M group
McGRATH video laryngoscope used to assist TEE probe insertion in an intubated patient under general anesthesia
Macintosh groupDevice
Also called C group
Macintosh laryngoscope used to assist TEE probe insertion in an intubated patient under general anesthesia
| Study group | Role | What they receive |
|---|---|---|
| McGRATH group | Active comparator | TEE probe insertion assisted by McGRATH MAC video laryngoscope in an intubated patient under general anesthesia, head in neutral position. Receives: Device: McGRATH group |
| Macintoch group | Active comparator | TEE probe insertion assisted by conventional Macintosh laryngoscope in an intubated patient under general anesthesia, head in neutral position. Receives: Device: Macintosh group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Immediately after TEE probe removal (intraoperatively)
Secondary outcomes (3)
Visibility of the oesophageal inlet
Categorical - "Visible" vs "Not visible" as recorded by the operator.
Measured: 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.
Measured: 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
Measured: During the intraoperative TEE probe insertion procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2026
- Study startJan 2026 (estimated)
- Primary completionJun 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Echocardiography, TransesophagealStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Collaborators
- Prince Sultan Cardiac Center, Adult Cardiology Department.
- Responsible party
- Principal investigator, Hassan Mohamed Ali, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07346898
- Sponsor's protocol ID
- H-01-R-096
- Status last verified
- Jan 2026
- First submitted
- 19 Dec 2025
- Last updated
- 16 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Insertion of a Transoesophageal Echocardiography Probe Using McGRATH Video Laryngoscope in Cardiac Surgery Patients: Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT07346898
- Acronym / sponsor ID
- H-01-R-096
- Conditions
- Echocardiography, Transesophageal, Cardiac Surgery
- Keywords
- cardiac anaesthesia, Transesophageal Echocardiography, pharyngeal mucosal injury
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Collaborators
- Prince Sultan Cardiac Center, Adult Cardiology Department.
- Study start
- Jan 2026 (estimated)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 16 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| McGRATH group | Active comparator | Device: McGRATH groupTEE probe insertion assisted by McGRATH MAC video laryngoscope in an intubated patient under general anesthesia, head in neutral position. |
| Macintoch group | Active comparator | Device: Macintosh groupTEE probe insertion assisted by conventional Macintosh laryngoscope in an intubated patient under general anesthesia, head in neutral position. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Dysphagia or sore throat
- Oropharyngeal infection
- Cervical spine pathology
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| McGRATH groupAlso: M groupMcGRATH video laryngoscope used to assist TEE probe insertion in an intubated patient under general anesthesia | Device | McGRATH group |
| Macintosh groupAlso: C groupMacintosh laryngoscope used to assist TEE probe insertion in an intubated patient under general anesthesia | Device | Macintoch group |
Primary outcome
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.
3 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing McGRATH group and Macintosh group in people with Echocardiography, Transesophageal and Cardiac Surgery, run by Cairo University at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 16 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ahmed Abdalwahab, MD (00966533437590, aabdalwahab@pscc.med.sa), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of pharyngeal mucosal injury (time frame: Immediately after TEE probe removal (intraoperatively)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2026.