Reduction of Laparoscopic-Induced Hypothermia, Postoperative Pain and Recovery Room Length of Stay by Pre-Conditioning Gas with the Insuflow® Device: A Prospective Randomized Controlled Multi-Center Study

OBJECTIVE: To assess the efficacy and safety of Insuflow® (Georgia BioMedical, Inc.) filter heater hydrator device in reducing the incidence, severity and extent of hypothermia, length of recovery room stay and postoperative pain at the time of laparoscopy. DESIGN: Prospective, randomized, blinded, controlled multi-center study. Patients underwent gynecologic procedures via laparoscopy; surgeons, anesthesiologists and recovery room personnel assessed the results. SETTING: Seven North American institutions. PATIENTS: Seventy-two women for safety evaluation and efficacy studies. INTERVENTIONS: Intraoperative pre-conditioning of laparoscopic gas with the Insuflow® device (treatment) or standard raw gas (control) during laparoscopic surgery and postoperatively. MAIN OUTCOME MEASURES: Incidence, severity and extent of hypothermia, postoperative pain perception and length of recovery room stay. RESULTS: The Insuflow® group had significantly less intra-operative hypothermia, reduced length of recovery room stay and reduced postoperative pain. Pre-conditioning of laparoscopic gas by filtering heating and hydrating was well tolerated with no adverse effects. The safety profile of the Insuflow® pre-conditioned gas showed significant benefits compared to currently used raw gas. CONCLUSIONS: Pre-conditioning laparoscopic gas by filtering heating and hydrating with the Insuflow® device was significantly more effective than the currently used standard raw gas and was safe in reducing or eliminating laparoscopic-induced hypothermia, shortening recovery room length of stay and reducing postoperative pain.