Effects of Warmed, Humidified CO2 Insufflation on Body Core Temperature and Cytokine Response

Hypothermia Clinical Trial

Official title:

Effects of Warmed, Humidified CO2 Insufflation on Body Core Temperature and Cytokine Response: Head-to-head Randomized Comparison Versus Standard Insufflation During Robot Assisted Radical Prostatectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02586974
• Other study ID #: 0052588
• Status: Completed
• Phase: N/A
• Start date: September 2015
• Est. completion date: August 2016

Study information

• Verified date: February 2020
• Source: Azienda Ospedaliera Città della Salute e della Scienza di Torino
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: August 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 40 Years to 80 Years

Eligibility

Inclusion Criteria:

• all patients undergoing RARP, with or without pelvic lymph node dissection, with a CO2 insufflation scheduled to last more than 60 minutes

Exclusion Criteria:

• patients over 80 years old, patients American Society of Anesthesiologist (ASA) status 4 or higher, patients not willing to sign the informed consent, conversions to open surgery

Related Conditions & MeSH terms

• Hypothermia

Intervention

Device:
• Humigard
warmed and humidified CO2 insufflation

Locations

Country	Name	City	State
Italy	A.O.U. San Giovanni Battista Molinette	Torino	TO

Sponsors (2)

Lead Sponsor	Collaborator
Azienda Ospedaliera Città della Salute e della Scienza di Torino	IRCAD - EITS

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intraoperative Change in Body Core Temperature	body core temperature of patients undergoing robot-assisted radical prostatectomy (RARP), measured with a disposable esophageal probe	Intraoperative at hourly intervals
Secondary	Cytokine Interleukin-6 (IL-6)	mean levels of the pro-inflammatory cytokine interleukin-6 (IL-6) in patients undergoing robot-assisted radical prostatectomy (RARP), measured just before induction of anesthesia, after 2 h of pneumoperitoneum, 2 h from exsufflation, and 24 h after surgery	changes in cytokine levels measured just before induction of anesthesia, after 2 h of pneumoperitoneum, 2 h from exsufflation, and 24 h after surgery
Secondary	Cytokine Tumor Necrosis Factor (TNF)-Beta	mean levels of the pro-inflammatory cytokine tumor necrosis factor (TNF)-beta in patients undergoing robot-assisted radical prostatectomy (RARP), measured just before induction of anesthesia, after 2 h of pneumoperitoneum, 2 h from exsufflation, and 24 h after surgery	changes in cytokine levels just before induction of anesthesia, after 2 h of pneumoperitoneum, 2 h from exsufflation, and 24 h after surgery
Secondary	Postoperative Pain	postoperative pain in patients undergoing robot-assisted radical prostatectomy (RARP) as measured by the Numeric Pain Rating Score (NRS), measured at patient awakening and after 12, 24, and 48 h from surgery. NRS goes from 0 to 10, where 0 means no pain and 10 the maximum pain possible.	changes in postoperative pain measured at patient awakening and then every 30 min in the recovery room, until discharge to the ward. Successively, it was measured at 12, 24, and 48 h