N/A
N=64
Effects of Warmed, Humidified CO2 Insufflation on Body Core Temperature and Cytokine Response
Hypothermia
Bottom Line
View on ClinicalTrials.gov: NCT02586974 ↗Enrolled (actual)
64
Serious AEs
0.0%
Results posted
Feb 2020
Primary outcome: Primary: Intraoperative Change in Body Core Temperature — 35.73; 35.70; 35.78; 35.77 degrees °C
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Humigard (Device)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- Male
- Sponsor
- A.O.U. Città della Salute e della Scienza
- Primary completion
- Jun 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Intraoperative Change in Body Core Temperature |
35.73; 35.70; 35.78; 35.77; 35.96; 35.90 | — |
| SECONDARY Cytokine Interleukin-6 (IL-6) |
2.13; 2.20; 4.61; 4.16; 29.13; 25.91 | — |
| SECONDARY Cytokine Tumor Necrosis Factor (TNF)-Beta |
5.74; 6.29; 5.69; 5.20; 5.44; 4.90 | — |
| SECONDARY Postoperative Pain |
2.5; 2.3; 1.6; 1.9; 1.3; 1.8 | — |
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).
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02586974). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.