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Monitoring oral mucosal microcirculation in healthy volunteers following oral cooling

Monitoring oral mucosal microcirculation in healthy volunteers following oral cooling - OralMicroCryo10

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON55691
Enrollment
10
Registered
2021-05-21
Start date
2021-04-30
Completion date
Unknown
Last updated
2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

cancer chemotherapy side effects in oral mucosa Effect of oral cooling on oral mucosa microcirculation effect of oral cryotherapy on oral mucosa microcirculation

Interventions

None listed

Sponsors

Academisch Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: ASA 1 volunteers • Signed an informed consent form • Volunteers recruited by advertisement >=18 years

Exclusion criteria

Exclusion criteria: • Past history of head and neck malignancy or other relevant pathologies • Previous history of radiation therapy to the head and neck • Volunteers that did not sign an informed consent form • Volunteers

Design outcomes

Primary

MeasureTime frame
Microcirculation measurements before and 30 min after oral cooling; total capillary density (TCD), functional capillary density (FCD), proportion of perfused capillaries (PPC) and microvascular flow index (MFI).

Secondary

MeasureTime frame
Mucosal oxygen saturation (StO2) and tissue haemoglobin index (THI) measurements before and 30 min after oral cooling.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)