Continuous Monitoring of Microvascular Anastomoses: An Observational Trial
ConditionHead and Neck Neoplasm
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorMayo Clinic
About this trial
This study is being done to see whether signals from a device that monitors blood flow through the free flap can be recorded and converted from an audible signal, like a heartbeat, into a visual signal. Researchers plan to use this information to ultimately help surgeons and care teams monitor free flaps to try to prevent flap failure.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Scheduled for free flap surgery and planned to have an implanted doppler monitor
Arterial Doppler waveforms available for analysis
Able and willing to sign consent and return for clinical follow up
Age ≥ 18 years
Disqualifiers
Prior head and neck surgery within the region where surgeons plan to identify donor vessels ≤ 365 days prior to registration
Trial population
Patients scheduled to undergo free flap surgery with an implantable doppler
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Non-Interventional Study
Other interventionNon-interventional study
Treatment groups
100 Participants
are divided into 1 treatment groupGroup A: Observational1 intervention
Trial outcomes
Primary outcomes
1
Feasibility - record audible doppler signal tracings
Ability to record a minimum of 2 audible doppler signal tracings from the implantable doppler per 24 hours for a minimum of one 24 hour period for 80% of subjects. Analysis of the primary endpoint will be done in a binary (yes/no) fashion to describe the feasibility of the proposed research recording device (RRD) to record and convert recorded signals into various visual formats. Recordings will be observed by study staff to determine whether auditory acuity matches expected signals.
Time frame
Up to 30 days2
Feasibility - convert audible doppler signal tracings to stored data files
Ability to convert the recorded doppler signal tracings to stored data files for 80% of subjects. Analysis of the primary endpoint will be done in a binary (yes/no) fashion to describe the feasibility of the proposed RRD to record and convert recorded signals into various visual formats.
Time frame
Up to 30 daysSecondary outcomes
1
Feasibility - convert audible data to visual signal to a visual signal
Ability to convert a minimum of 80% of the audible data files to a visual signal. Analysis of the primary endpoint will be done in a binary (yes/no) fashion to describe the feasibility of the proposed RRD to record and convert recorded signals into various visual formats. Visual displays will be observed by study staff to confirm the display matches the expected form, as informed by prior experience/literature with doppler studies of peripheral vasculature. The specific methods for visualization will include a multimodal approach that includes Doppler signal time-series waveform, spectrogram, and Fourier Transform.
Time frame
Up to 30 daysOther outcomes
1
AI algorithm
Ability to build a predictive artificial intelligence (AI) algorithm for identifying high-risk or compromised flaps using a neural network.
Time frame
Up to 2 yearsSponsors and contacts
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Source ClinicalTrials.gov