Monitoring Tissue Oxygen Levels After Upper or Lower Limb Reconstructive Surgery Using the FORE-SIGHT ELITE NIRS Device

What this Trial Is About

Researchers are studying patients who have undergone reconstructive surgery on their upper or lower limbs using an anterolateral thigh flap. The study aims to monitor these patients after surgery to better detect flap failure, a complication caused by blood flow problems. This observational pilot study focuses on combining traditional clinical assessments with continuous tissue oxygenation measurements using a near-infrared spectroscopy NIRS device called FORE-SIGHT ELITE. The goal is to find preliminary data on tissue oxygenation cut-off values that may indicate flap failure. During the study, patients will be monitored using the current gold standard methods, which include checking the flaps skin color, temperature, tissue turgor, capillary refill time, and Doppler techniques. Alongside these, continuous tissue oxygenation will be measured with the FORE-SIGHT ELITE device, with sensors placed at both the flap and donor sites after surgery. These oxygenation readings will be blinded to patients and nursing staff during the five-day monitoring period. Patients will stay overnight in the Post Anesthetic Care Unit PACU and then transfer to a regular ward, where clinical checks will continue. Participants clinical assessments will be performed hourly during the first 24 hours and regularly thereafter, including vital signs monitoring. Nurses will notify surgeons if clinical signs suggest flap problems. After five days, researchers will analyze the stored NIRS data comparing patients with flap failure to those without. The study will also perform a retrospective time-to-event analysis in patients with flap failure over about one year to better understand tissue oxygenation trends. This monitoring aims to improve early detection of flap failure and guide timely treatment.

Anterolateral Tigh (ALT) Flaps Oxygenation Monitoring by NIRS