Obianuju S Madueke-Laveaux1, Arnold Advincula2, Cara L Grimes2, Ryan Walters2, Jin Hee Kim2, Khara Simpson2, Mireille Truong2, Constance Young2, Ruth Landau2, Timothy Ryntz2. 1. Departments of Obstetrics and Gynecology (Drs. Advincula, Walters, Kim, and Ryntz); Anesthesiology (Dr. Landau), Columbia University Medical Center, New York, New York; Department of Obstetrics and Gynecology (Dr. Madueke-Laveaux), University of Chicago, Chicago, Illinois; Department of Obstetrics and Gynecology (Dr. Grimes), New York Medical College, Valhalla, New York; Department of Obstetrics and Gynecology (Dr. Simpson), Johns Hopkins University, Baltimore, Maryland; Department of Obstetrics and Gynecology (Dr. Truong), Virginia Commonwealth University, Richmond, Virginia; Department of Obstetrics and Gynecology (Dr. Young), Mount Sinai Hospital, New York, New York. Electronic address: somadueke@gmail.com. 2. Departments of Obstetrics and Gynecology (Drs. Advincula, Walters, Kim, and Ryntz); Anesthesiology (Dr. Landau), Columbia University Medical Center, New York, New York; Department of Obstetrics and Gynecology (Dr. Madueke-Laveaux), University of Chicago, Chicago, Illinois; Department of Obstetrics and Gynecology (Dr. Grimes), New York Medical College, Valhalla, New York; Department of Obstetrics and Gynecology (Dr. Simpson), Johns Hopkins University, Baltimore, Maryland; Department of Obstetrics and Gynecology (Dr. Truong), Virginia Commonwealth University, Richmond, Virginia; Department of Obstetrics and Gynecology (Dr. Young), Mount Sinai Hospital, New York, New York.
Abstract
STUDY OBJECTIVE: The primary objective was to compare carbon dioxide (CO2) absorption rates in patients undergoing gynecologic laparoscopy with a standard versus valveless insufflation system (AirSeal; ConMed, Utica, NY) at intra-abdominal pressures (IAPs) of 10 and 15 mm Hg. Secondary objectives were assessment of surgeons' visualization of the operative field, anesthesiologists' ability to maintain adequate end-tidal CO2 (etCO2), and patients' report of postoperative shoulder pain. DESIGN: A randomized controlled trial using an equal allocation ratio into 4 arms: standard insufflation/IAP 10 mm Hg, standard insufflation/IAP 15 mm Hg, valveless insufflation/IAP 10 mm Hg, and valveless insufflation/IAP 15 mm Hg. SETTING: Single tertiary care academic institution. PATIENTS: Women ≥ 18 years old undergoingnonemergent conventional or robotic gynecologic laparoscopic surgery. INTERVENTIONS: A standard or valveless insufflation system at IAPs of 10 or 15 mm Hg. MEASUREMENTS AND MAIN RESULTS:One hundred thirty-two patients were enrolled and randomized with 33 patients per group. There were 84 robotic cases and 47 conventional laparoscopic cases. CO2 absorption rates (mL/kg*min) did not differ across groups with mean rates of 4.00 ± 1.3 in the valveless insufflation groups and 4.00 ± 1.1 in the standard insufflation groups. The surgeons' rating of overall visualization of the operative field on a 10-point Likert scale favored the valveless insufflation system (median visualization, 9.0 ± 2.0 cm and 9.5 ± 1.8 cm at 10 and 15 mm Hg, respectively) over standard insufflation (7.0 ± 3.0 cm and 7.0 ± 2.0 cm at 10 and 15 mm Hg, respectively; p <.001). The anesthesiologists' ability to maintain adequate etCO2 was similar across groups (p = .417). Postoperative shoulder pain scores were low overall with no significant difference across groups (p >.05). CONCLUSION:CO2 absorption rates, anesthesiologists' ability to maintain adequate etCO2, and postoperative shoulder pain did not differ based on insufflation system type or IAP. Surgeons' rating of visualization of the operative field was significantly improved when using the valveless over the standard insufflation system.
RCT Entities:
STUDY OBJECTIVE: The primary objective was to compare carbon dioxide (CO2) absorption rates in patients undergoing gynecologic laparoscopy with a standard versus valveless insufflation system (AirSeal; ConMed, Utica, NY) at intra-abdominal pressures (IAPs) of 10 and 15 mm Hg. Secondary objectives were assessment of surgeons' visualization of the operative field, anesthesiologists' ability to maintain adequate end-tidal CO2 (etCO2), and patients' report of postoperative shoulder pain. DESIGN: A randomized controlled trial using an equal allocation ratio into 4 arms: standard insufflation/IAP 10 mm Hg, standard insufflation/IAP 15 mm Hg, valveless insufflation/IAP 10 mm Hg, and valveless insufflation/IAP 15 mm Hg. SETTING: Single tertiary care academic institution. PATIENTS: Women ≥ 18 years old undergoing nonemergent conventional or robotic gynecologic laparoscopic surgery. INTERVENTIONS: A standard or valveless insufflation system at IAPs of 10 or 15 mm Hg. MEASUREMENTS AND MAIN RESULTS: One hundred thirty-two patients were enrolled and randomized with 33 patients per group. There were 84 robotic cases and 47 conventional laparoscopic cases. CO2 absorption rates (mL/kg*min) did not differ across groups with mean rates of 4.00 ± 1.3 in the valveless insufflation groups and 4.00 ± 1.1 in the standard insufflation groups. The surgeons' rating of overall visualization of the operative field on a 10-point Likert scale favored the valveless insufflation system (median visualization, 9.0 ± 2.0 cm and 9.5 ± 1.8 cm at 10 and 15 mm Hg, respectively) over standard insufflation (7.0 ± 3.0 cm and 7.0 ± 2.0 cm at 10 and 15 mm Hg, respectively; p <.001). The anesthesiologists' ability to maintain adequate etCO2 was similar across groups (p = .417). Postoperative shoulder pain scores were low overall with no significant difference across groups (p >.05). CONCLUSION:CO2 absorption rates, anesthesiologists' ability to maintain adequate etCO2, and postoperative shoulder pain did not differ based on insufflation system type or IAP. Surgeons' rating of visualization of the operative field was significantly improved when using the valveless over the standard insufflation system.
Authors: Alessandro Buda; Giampaolo Di Martino; Martina Borghese; Stefano Restaino; Alessandra Surace; Andrea Puppo; Sara Paracchini; Debora Ferrari; Stefania Perotto; Antonia Novelli; Elena De Ponti; Chiara Borghi; Francesco Fanfani; Robert Fruscio Journal: Healthcare (Basel) Date: 2022-03-14