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

D E Ott, H Reich, B Love, R McCorvey, A Toledo, C Y Liu, R Syed, K Kumar, D E Ott, H Reich, B Love, R McCorvey, A Toledo, C Y Liu, R Syed, K Kumar

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.

Figures

Figure 1a.
Figure 1a.
No Insuflow®.
Figure 1b.
Figure 1b.
Insuflow® device used.
Figure 2.
Figure 2.
Insuflow® versus raw gas comparison.
Figure 3.
Figure 3.
Body Temperature.
Figure 4.
Figure 4.
Shoulder pain.
Figure 5.
Figure 5.
Comparison of length of stay standard raw gas versus heated hydra ted pre-conditioned gas.

References

    1. Ott DE. Contamination via gynecologic endoscopy insufflation. J Gyn Surg. 1989;5:205–208
    1. Bessell JR, Karatassas A, Patterson JR, Jamieson GG, Maddern GJ. Hypothermia induced by laparoscopic insufflation. Surg Endosc. 1995;9:791–796
    1. Bessell JR, Maddern GJ. Influence of gas temperature during laparoscopic procedures. In Rosenthal RJ, Friedman RL, Phillips EH. eds. The Pathophysiology of Pneumo-peritoneum. Berlin: Springer-Verlag; 1998
    1. Ott DE. Correction of laparoscopic insufflation hypothermia. J Laparoendosc Surg. 1991;1:183–186
    1. Ott DE. Laparoscopic hypothermia. J Laparoendosc Surg. 1991;1:127–131
    1. Korell M, Schmaus F, Strowitzki T, Schneeweiss SG, Hepp H. Pain intensity following laparoscopy. Surg Laparosc Endosc. 1996;6:375–379
    1. Mouton WG, Bessell JR, Millard SH, Maddern GL. A randomized controlled trial assessing the benefit of humidified insufflation gas during laparoscopic surgery. Rome Abstract World Congress Endoscopy to be published in Endoscopic Surgery.
    1. Semm K, Arp WD, Trappe M, Kube D. Pain reduction after pelvi-laparoscopic interventions by insufflation of CO2 gas at body temperature. Gerburts Frauen. 1994;54:300–304
    1. Beery H, Husskinson EC. Measurement of pain. J Clin Trials. 1972;9:13–18
    1. United States Pharmacopeia and National Formulary and Supplements, XXI-NF, 1984
    1. Diamond MP. Adhesion prevention. In Gershenson DM, DeCherney AH, Curry SL. eds. Operative Gynecology. Philadelphia: WB Saunders Company; 1993:147–158
    1. DiZerga GS. The peritoneum and its response to surgical injury. In DiZerga GS, Malinak LR, Diamond MP, Linsky CB. eds. Treatment of Post Surgical Adhesions. New York: Wiley-Liss; 1990
    1. Ott DE. Microbial colonization of laparoscopic gas delivery systems: a quantitative analysis. JSLS. 1997;1:325–329
    1. Couper GW, Ewen SW, Krukowski ZH. Risk of contamination from laparoscopic carbon dioxide insufflators. J R Coll Surg Edinb. 1997;42:231–232
    1. Ryan GB, Groberty J, Majno G. Mesothelial injury and repair. Am J Path. 1973;71:93–112
    1. Gray RI, Henderson AC, Ott DE. Severe local hypothermia from laparoscopic gas, evaporative jet cooling. Ann Biomed Engineering. 1997;25:Suppl 1, Abstract 28
    1. Morris RH, Kumar A. The effect of warming blankets on maintenance of body temperature of the anesthetized, paralyzed adult patient. Anesthesiology. 1970;36:408–411
    1. Carli F, Emery PW, Freemantle CAJ. Effect of perioperative normothermia on postoperative protein metabolism. Br J Anesth. 1989;63:276–282
    1. Michelson AD, MacGregor H, Barnard MR, Kestin AS, Roher MJ, Valeri CR. Reversible inhibition of human platelet activation by hypothermia in vivo and in vitro. Throm Haemost. 1994;71:633–640
    1. Kurz A, Sessler DI, Lenhardt R. Perioperative normothermia to reduce the incidence of surgical-wound infection and shorten hospitalization. NEJM. 1996;334:1209–1215
    1. Lenhardt R, Kurz A, Sessler DI, Marker E, Narzt E, Lackner F. Intra-operative hypothermia prolongs duration of postoperative recovery. Anesthesiology. 1995;83:Suppl:A1114 abstract
    1. Lenhardt R, Marker E, Goll V, Tschernich H, Sessler DI, Narzt E, Lackner F. Mild intraoperative hypothermia prolongs postanesthetic recovery. Anesthesiology. 1997;87:1318–1323
    1. Frank SM, Higgins MS, Breslow MJ, et al. The catecholamine, cortisol and hemodynamic responses to mild perioperative hypothermia: a randomized clinical trial. Anesthesiology. 1995;82:83–93
    1. Kurz A, Sessler DI, Nartz E, et al. Postoperative hemodynamic and thermoregulatory consequences of intra-operative core hypothermia. J Clin Anesth. 1995;73:59–7366
    1. Frank SM, Fleisher LA, Breslow MJ, et al. Perioperative maintenance of normothermia reduces the incidence of morbid cardiac events: a randomized clinical trial. JAMA. 1997;227:1127–1134
    1. Sessler DI. Perianesthetic thermoregulation and heat balance in humans. FASEB J. 1993;7:638–644
    1. Conahan TJ. Heating reduces recovery time (cost) in out-patients. Anesthesiology. 1982;67:128–130

Source: PubMed

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

3
Abonner