Trial Outcomes & Findings for Effects of Warmed, Humidified CO2 Insufflation on Body Core Temperature and Cytokine Response (NCT NCT02586974)
NCT ID: NCT02586974
Last Updated: 2025-01-30
Results Overview
body core temperature of patients undergoing robot-assisted radical prostatectomy (RARP), measured with a disposable esophageal probe
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
64 participants
Primary outcome timeframe
Intraoperative at hourly intervals
Results posted on
2025-01-30
Participant Flow
All patients undergoing RARP at Città della Salute e della Scienza Hospital between September 2015 and June 2016 were screened for inclusion.
Exclusion criteria were as follows: age \>80 years, ASA status \>3, allergic status needing corticosteroid premedication, refusal to sign the informed consent, cognitive disability, conversion to open surgery.
Participant milestones
| Measure |
Group H+WB
32 patients will receive warmed, humidified CO2 insufflation with the Humigard® device, along with the hot air warming blanket used as a routine in our institution (forced air warming blanket at 38°C : Bear Hugger®)
Humigard: warmed and humidified CO2 insufflation
|
Group WB
32 patients will receive standard CO2 insufflation, along with the hot air warming blanket used as a routine in our institution (forced air warming blanket at 38°C : Bear Hugger® and a standard insufflation with non-humidified, non-heated CO2)
|
|---|---|---|
|
Overall Study
STARTED
|
32
|
32
|
|
Overall Study
COMPLETED
|
32
|
32
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effects of Warmed, Humidified CO2 Insufflation on Body Core Temperature and Cytokine Response
Baseline characteristics by cohort
| Measure |
Group H+WB
n=32 Participants
32 patients will receive warmed, humidified CO2 insufflation with the Humigard® device, along with the hot air warming blanket used as a routine in our institution (forced air warming blanket at 38°C : Bear Hugger®)
Humigard: warmed and humidified CO2 insufflation
|
Group WB
n=32 Participants
32 patients will receive standard CO2 insufflation, along with the hot air warming blanket used as a routine in our institution (forced air warming blanket at 38°C : Bear Hugger® and a standard insufflation with non-humidified, non-heated CO2)
|
Total
n=64 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
66.4 years
STANDARD_DEVIATION 7.0 • n=5 Participants
|
64.4 years
STANDARD_DEVIATION 9.0 • n=7 Participants
|
65.4 years
STANDARD_DEVIATION 8.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
32 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
64 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
32 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
64 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Italy
|
32 participants
n=5 Participants
|
32 participants
n=7 Participants
|
64 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Intraoperative at hourly intervalsbody core temperature of patients undergoing robot-assisted radical prostatectomy (RARP), measured with a disposable esophageal probe
Outcome measures
| Measure |
Group Humigard+Warming Blanket (H+WB)
n=32 Participants
32 patients will receive warmed, humidified CO2 insufflation with the Humigard® device, along with the hot air warming blanket used as a routine in our institution (forced air warming blanket at 38°C : Bear Hugger®)
Humigard: warmed and humidified CO2 insufflation
|
Group Warming Blanket (WB)
n=32 Participants
32 patients will receive standard CO2 insufflation, along with the hot air warming blanket used as a routine in our institution (forced air warming blanket at 38°C : Bear Hugger® and a standard insufflation with non-humidified, non-heated CO2)
|
|---|---|---|
|
Intraoperative Change in Body Core Temperature
start of surgery
|
35.73 degrees °C
Standard Deviation 0.37
|
35.70 degrees °C
Standard Deviation 0.34
|
|
Intraoperative Change in Body Core Temperature
after 1h
|
35.78 degrees °C
Standard Deviation 0.42
|
35.77 degrees °C
Standard Deviation 0.37
|
|
Intraoperative Change in Body Core Temperature
after 2h
|
35.96 degrees °C
Standard Deviation 0.53
|
35.90 degrees °C
Standard Deviation 0.41
|
|
Intraoperative Change in Body Core Temperature
after 3h
|
36.11 degrees °C
Standard Deviation 0.60
|
36.07 degrees °C
Standard Deviation 0.52
|
|
Intraoperative Change in Body Core Temperature
after 4h
|
36.34 degrees °C
Standard Deviation 0.64
|
36.07 degrees °C
Standard Deviation 0.55
|
|
Intraoperative Change in Body Core Temperature
end of surgery
|
36.26 degrees °C
Standard Deviation 0.69
|
36.06 degrees °C
Standard Deviation 0.62
|
SECONDARY outcome
Timeframe: changes in cytokine levels measured just before induction of anesthesia, after 2 h of pneumoperitoneum, 2 h from exsufflation, and 24 h after surgerymean 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
Outcome measures
| Measure |
Group Humigard+Warming Blanket (H+WB)
n=32 Participants
32 patients will receive warmed, humidified CO2 insufflation with the Humigard® device, along with the hot air warming blanket used as a routine in our institution (forced air warming blanket at 38°C : Bear Hugger®)
Humigard: warmed and humidified CO2 insufflation
|
Group Warming Blanket (WB)
n=32 Participants
32 patients will receive standard CO2 insufflation, along with the hot air warming blanket used as a routine in our institution (forced air warming blanket at 38°C : Bear Hugger® and a standard insufflation with non-humidified, non-heated CO2)
|
|---|---|---|
|
Cytokine Interleukin-6 (IL-6)
after 2h
|
4.61 IU
Standard Deviation 5.04
|
4.16 IU
Standard Deviation 3.5
|
|
Cytokine Interleukin-6 (IL-6)
2h from exsufflation
|
29.13 IU
Standard Deviation 24.18
|
25.91 IU
Standard Deviation 22.9
|
|
Cytokine Interleukin-6 (IL-6)
24h after surgery
|
27.01 IU
Standard Deviation 25.12
|
23.67 IU
Standard Deviation 25.8
|
|
Cytokine Interleukin-6 (IL-6)
start of surgery
|
2.13 IU
Standard Deviation 2.07
|
2.20 IU
Standard Deviation 2.2
|
SECONDARY outcome
Timeframe: changes in cytokine levels just before induction of anesthesia, after 2 h of pneumoperitoneum, 2 h from exsufflation, and 24 h after surgerymean 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
Outcome measures
| Measure |
Group Humigard+Warming Blanket (H+WB)
n=32 Participants
32 patients will receive warmed, humidified CO2 insufflation with the Humigard® device, along with the hot air warming blanket used as a routine in our institution (forced air warming blanket at 38°C : Bear Hugger®)
Humigard: warmed and humidified CO2 insufflation
|
Group Warming Blanket (WB)
n=32 Participants
32 patients will receive standard CO2 insufflation, along with the hot air warming blanket used as a routine in our institution (forced air warming blanket at 38°C : Bear Hugger® and a standard insufflation with non-humidified, non-heated CO2)
|
|---|---|---|
|
Cytokine Tumor Necrosis Factor (TNF)-Beta
2h from exsufflation
|
5.44 IU
Standard Deviation 5.3
|
4.90 IU
Standard Deviation 4.5
|
|
Cytokine Tumor Necrosis Factor (TNF)-Beta
start of surgery
|
5.74 IU
Standard Deviation 4.8
|
6.29 IU
Standard Deviation 6.6
|
|
Cytokine Tumor Necrosis Factor (TNF)-Beta
after 2h
|
5.69 IU
Standard Deviation 5.8
|
5.20 IU
Standard Deviation 4.2
|
|
Cytokine Tumor Necrosis Factor (TNF)-Beta
24h after surgery
|
6.11 IU
Standard Deviation 5.7
|
7.24 IU
Standard Deviation 6.0
|
SECONDARY outcome
Timeframe: 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 hpostoperative 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.
Outcome measures
| Measure |
Group Humigard+Warming Blanket (H+WB)
n=32 Participants
32 patients will receive warmed, humidified CO2 insufflation with the Humigard® device, along with the hot air warming blanket used as a routine in our institution (forced air warming blanket at 38°C : Bear Hugger®)
Humigard: warmed and humidified CO2 insufflation
|
Group Warming Blanket (WB)
n=32 Participants
32 patients will receive standard CO2 insufflation, along with the hot air warming blanket used as a routine in our institution (forced air warming blanket at 38°C : Bear Hugger® and a standard insufflation with non-humidified, non-heated CO2)
|
|---|---|---|
|
Postoperative Pain
At 12 hours
|
1.6 Units on a scale
Standard Deviation 1.8
|
1.9 Units on a scale
Standard Deviation 2.2
|
|
Postoperative Pain
Patient awakening
|
2.5 Units on a scale
Standard Deviation 2.6
|
2.3 Units on a scale
Standard Deviation 2.8
|
|
Postoperative Pain
At 24 hours
|
1.3 Units on a scale
Standard Deviation 1.5
|
1.8 Units on a scale
Standard Deviation 2.1
|
|
Postoperative Pain
At 48 hours
|
0.6 Units on a scale
Standard Deviation 1.1
|
1.1 Units on a scale
Standard Deviation 1.9
|
Adverse Events
Group H+WB
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group WB
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Marco Oderda
Città della Salute e della Scienza di Torino - Ospedale Molinette
Phone: +393479383465
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place