Head and Neck Neoplasm
Conditions
Brief summary
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.
Interventions
OTHERNon-Interventional Study
Non-interventional study
Sponsors
Mayo Clinic
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* Prior head and neck surgery within the region where surgeons plan to identify donor vessels ≤ 365 days prior to registration
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility - record audible doppler signal tracings | Up to 30 days | 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. |
| Feasibility - convert audible doppler signal tracings to stored data files | Up to 30 days | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility - convert audible data to visual signal to a visual signal | Up to 30 days | 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. |
Countries
United States
Contacts
CONTACTClinical Trials Referral Office
CONTACTColleen Dickman
PRINCIPAL_INVESTIGATORKathryn M. Van Abel, MD
Mayo Clinic in Rochester
Outcome results
None listed