A phase I, nonrandomized controlled trial demonstrating the novel technique of cytoreductive surgery and hyperthermic intraperitoneal chemotherapy utilizing warm humidified carbon dioxide insufflation

Aim: The aim of this work was to report on the safety and feasibility of warm humidified CO2 (WHCO2) insufflation during cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC). Method: Ten consecutive patients with histologically confirmed peritoneal cancer were enrolled in this phase I pilot nonrandomized controlled trial. They were alternately assigned to CRS and HIPEC with WHCO2 versus standard procedure. WHCO2 was delivered at 10 L/min, a pressure of 4.5 bar, 37ºC and 98% relative humidity during CRS using the HumiGardTM system. HIPEC was performed with an open abdomen using the Coliseum technique at 42ºC for 60 min. All patients were admitted to the intensive care unit and commenced on total parenteral nutrition postoperatively. Surface and core temperatures were measured every 30 min using an infrared camera and nasopharyngeal probe, respectively. Clinicopathological, intra- and postoperative details were collated between groups, and median surface and core temperatures were statistically compared. Results: Surface and core temperatures were generally higher in the WHCO2 group. Core temperature at 120 and 180 min was significantly higher in the WHCO2 versus the non-WHCO2 group (p = 0.028 and 0.008, respectively). There was a significant linear relationship between core and surface temperature at 30, 60, 90, 120, 150 and 180 min (p = 0.033, 0.004, 0.007, 0.021, 0.009 and 0.006, respectively). The peritoneal cancer index was lower but the estimated blood loss was higher in the non-WHCO2 than the WHCO2 group. Conclusion: WHCO2 in CRS and HIPEC appears to be safe and feasible. An appropriately powered phase II trial will be required to determine if WHCO2 is associated with improved intra- and postoperative outcomes.