Pilot, Controlled, Double-blind Study to Evaluate the Effect of the Exposome Anionic Enrichment System (Biow) on Hospital Recovery Quality, Clinical Response, and Sleep Quality in Postoperative Patients

What this Trial Is About

Researchers are investigating the effects of the EOX anion-enriched hospital room system on postoperative recovery and sleep quality in patients undergoing elective general surgery, especially hepatobiliary procedures. This pilot, controlled, double-blind study evaluates how modifying the indoor air environment by reducing oxidative stress and improving mitochondrial function may support physiological healing and improve inpatient recovery. The study is led by the Instituto de InvestigaciF3n Sanitaria de la FundaciF3n JimE9nez DEDaz and focuses on hospitalized postoperative patients at medium or high risk of oxidative stress or mitochondrial dysfunction. Participants are randomly assigned to hospital rooms equipped either with an active EOX device that continuously regenerates air and releases bioavailable anions using cold atmospheric plasma for 96 hours post-surgery or to rooms with an inactive device providing placebo exposure. The active device filters particulate matter, pathogens, and volatile compounds while modulating cellular oxidative balance. Both groups experience continuous exposure in their hospital rooms during the first 96 hours after surgery. During the study, researchers will monitor subjective measures such as sleep quality and well-being alongside objective assessments including vital signs, metabolomics, and microbiota composition. The primary outcome is the hormetic clinical response to EOX exposure during the first 96 hours post-surgery. Safety and clinical recovery will be followed during hospitalization, with the goal of understanding whether the EOX system can enhance tissue recovery and metabolic resilience in postoperative patients.

Double-blind Pilot Study on the Effect of Anionic Exposome Enrichment (Biow) on Recovery and Sleep Quality in Postoperative Patients