Introducing Laser Speckle contrast imaging in the hybrid operating theatre in patients with PAOD

Introducing Laser Speckle Contrast Imaging, in an endovascular operating program in the hybrid operating theatre, for visualisation of the microcirculation of the foot, in patients with PAOD

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON23881

Enrollment

Registered

2018-05-30

Start date

2018-08-01

Completion date

Unknown

Last updated

2024-06-11

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

Conditions

peripheral arterial occlusive disease

Interventions

Two LSCI measurements will be made before general anaesthesia. Two LSCI measurements will be made directly after applying general anaesthesia. Continuous LSCI measurements are performed during the

Eligibility

Inclusion criteria

Inclusion criteria: - Patients with end stage PAOD (Rutherford CLI grade 4-5-6) - First/initial intervention for PAOD - Procedures performed in the HOT, MST Enschede - Procedures performed under general anaesthesia - Aged 18 years or more

Exclusion criteria

Exclusion criteria: - Re-interventions for PAOD - Amputation (partial) of foot or toes in medical history - Local anaesthesia - Multiple drug resistance (MDR) (Dutch: BRMO) - Tattoo at the plantar side of the foot

Design outcomes

Primary

Measure	Time frame
The primary objective is to analyse whether LSCI could be integrated in a PAOD endovascular operation program in a HOT, for the visualisation of the foot microcirculation. If LSCI could be integrated, the primary objective will be extended to determine a correlation between LSCI outcome values and clinical outcome after an endovascular procedure in patients with PAOD.	—

Secondary

Measure	Time frame
Secondary Objective(s): - Inter-subject reproducibility for LSCI - Stability/continuity of the measurements, influences of movement artefacts - Influence of general anaesthesia on measurement outcome values - Analyse if there is a drift/arise of a system error, in the measurements during long measurements (>1 hour) o Environmental origin (e.g. temperature) o System induced drift	—

Contacts

Public ContactB. Wermelink

b.wermelink@mst.nl;+31631963629;

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)