Effects of Warmed, Humidified CO2 Insufflation on Body Core Temperature and Cytokine Response
Condition: Hypothermia
MeSH terms: Hypothermia
Study type: Interventional

Summary: 
      The aim of this study is to assess if the conditioning of the insufflation carbon dioxide
      (CO2) allows for an additional benefit in terms of prevention of the heat loss, when compared
      with the usual prevention with a forced warm air blanket alone, in the setting of
      robot-assisted radical prostatectomy (RARP).
    

Detailed description: 
      Among the possible consequences of cool and dry gas insufflation during laparoscopic
      procedures are hypothermia and cytokine response, which might cause significant perioperative
      morbidity. More in detail, body core temperature decrease during laparoscopic surgery has
      been calculated in humans as 0.3 °C for every 50 L of cold and dry insufflation gas. The
      reported temperature drop is caused by redistribution of heat and heat loss, both
      non-specific (due to anaesthesia and environmental patient exposure) and specific (due to
      peritoneal dry and cool insufflations). The resulting hypothermia can be severe, particularly
      after prolonged surgery. As for cytokine response, an increase of several pro-inflammatory
      cytokines has been described following the irritating effect of peritoneal CO2 insufflation.

      That said, various devices of conditioning of the insufflating gas have been investigated to
      reduce the specific heat losses resulting from peritoneal insufflations, as well as to
      evaluate the inflammatory response. Previous studies conducted on animal models and clinical
      settings have suggested that warmed and humidified insufflation allows for an improved
      maintenance of body core temperature, a reduction in the degree of inflammatory response and
      an improved quality of postoperative course, compared with standard insufflating gas. These
      findings, however, are still not conclusive as they have not been confirmed by adequate
      randomized, controlled trials. Furthermore, no device providing warming and humidification
      has demonstrated a conclusive advantage over standard cold dry gas in terms of prevention of
      hypothermia during laparoscopy in man.

      On the basis of the current available studies favouring warmed and humidified insufflation,
      the investigators hypothesize that a new device providing warmed and humidified insufflation
      (Humigard® Fisher and Paykel Healthcare®) might achieve significant benefits over standard
      insufflation in terms of body core temperature maintenance. The investigators also expect to
      document a decrease of pro-inflammatory cytokines, as a response to a diminished peritoneal
      irritation.
    

Intervention name(s): Humigard
Intervention type(s): Device
Intervention description(s): warmed and humidified CO2 insufflation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Supportive Care
Keywords: CO2 insufflation; robot assisted radical prostatectomy; laparoscopy; hypothermia; cytokine response