Abstract:

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 intraoperative 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.

Keywords: GAS HYDRATION; LAPAROSCOPIC HYPOTHERMIA; PAIN; LENGTH OF STAY; LAPAROSCOPY; PERITONEUM

Document Type: Research article

Affiliations: 1: School of Engineering, Mercer University, Macon, GA 2: Columbia-Presbyterian-Sloan Hospital, Columbia University, New York 3: Reproductive Biology Associates, Atlanta, Georgia 4: Chattanooga Women's Center, Chattanooga, Tennessee 5: Staten Island University Hospital, Staten Island, New York 6: Capital Hospital, Richmond, Virginia