Hypothermia
Conditions
Keywords
CO2 insufflation, robot assisted radical prostatectomy, laparoscopy, hypothermia, cytokine response
Brief 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.
Interventions
DEVICEHumigard
warmed and humidified CO2 insufflation
Sponsors
IRCAD - EITS
A.O.U. Città della Salute e della Scienza
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
MALE
Age
40 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intraoperative Change in Body Core Temperature | Intraoperative at hourly intervals | body core temperature of patients undergoing robot-assisted radical prostatectomy (RARP), measured with a disposable esophageal probe |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cytokine Interleukin-6 (IL-6) | changes in cytokine levels measured just before induction of anesthesia, after 2 h of pneumoperitoneum, 2 h from exsufflation, and 24 h after surgery | 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 |
| Cytokine Tumor Necrosis Factor (TNF)-Beta | changes in cytokine levels just before induction of anesthesia, after 2 h of pneumoperitoneum, 2 h from exsufflation, and 24 h after surgery | 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 |
| Postoperative Pain | 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 | 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. |
Countries
Italy
Participant flow
Recruitment details
All patients undergoing RARP at Città della Salute e della Scienza Hospital between September 2015 and June 2016 were screened for inclusion.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 32 |
| 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) | 32 |
| Total | 64 |
Baseline characteristics
| Characteristic | Group H+WB | Total | Group WB |
|---|---|---|---|
| Age, Continuous | 66.4 years STANDARD_DEVIATION 7 | 65.4 years STANDARD_DEVIATION 8 | 64.4 years STANDARD_DEVIATION 9 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 32 Participants | 64 Participants | 32 Participants |
| Region of Enrollment Italy | 32 participants | 64 participants | 32 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 32 Participants | 64 Participants | 32 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 32 | 0 / 32 |
| other Total, other adverse events | 0 / 32 | 0 / 32 |
| serious Total, serious adverse events | 0 / 32 | 0 / 32 |
Outcome results
Primary
Intraoperative Change in Body Core Temperature
body core temperature of patients undergoing robot-assisted radical prostatectomy (RARP), measured with a disposable esophageal probe
Time frame: Intraoperative at hourly intervals
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group Humigard+Warming Blanket (H+WB) | Intraoperative Change in Body Core Temperature | after 1h | 35.78 degrees °C | Standard Deviation 0.42 |
| Group Humigard+Warming Blanket (H+WB) | Intraoperative Change in Body Core Temperature | after 3h | 36.11 degrees °C | Standard Deviation 0.6 |
| Group Humigard+Warming Blanket (H+WB) | Intraoperative Change in Body Core Temperature | after 4h | 36.34 degrees °C | Standard Deviation 0.64 |
| Group Humigard+Warming Blanket (H+WB) | Intraoperative Change in Body Core Temperature | start of surgery | 35.73 degrees °C | Standard Deviation 0.37 |
| Group Humigard+Warming Blanket (H+WB) | Intraoperative Change in Body Core Temperature | end of surgery | 36.26 degrees °C | Standard Deviation 0.69 |
| Group Humigard+Warming Blanket (H+WB) | Intraoperative Change in Body Core Temperature | after 2h | 35.96 degrees °C | Standard Deviation 0.53 |
| Group Warming Blanket (WB) | Intraoperative Change in Body Core Temperature | end of surgery | 36.06 degrees °C | Standard Deviation 0.62 |
| Group Warming Blanket (WB) | Intraoperative Change in Body Core Temperature | start of surgery | 35.70 degrees °C | Standard Deviation 0.34 |
| Group Warming Blanket (WB) | Intraoperative Change in Body Core Temperature | after 1h | 35.77 degrees °C | Standard Deviation 0.37 |
| Group Warming Blanket (WB) | Intraoperative Change in Body Core Temperature | after 2h | 35.90 degrees °C | Standard Deviation 0.41 |
| Group Warming Blanket (WB) | Intraoperative Change in Body Core Temperature | after 4h | 36.07 degrees °C | Standard Deviation 0.55 |
| Group Warming Blanket (WB) | Intraoperative Change in Body Core Temperature | after 3h | 36.07 degrees °C | Standard Deviation 0.52 |
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
Time frame: changes in cytokine levels measured just before induction of anesthesia, after 2 h of pneumoperitoneum, 2 h from exsufflation, and 24 h after surgery
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group Humigard+Warming Blanket (H+WB) | Cytokine Interleukin-6 (IL-6) | start of surgery | 2.13 IU | Standard Deviation 2.07 |
| Group Humigard+Warming Blanket (H+WB) | Cytokine Interleukin-6 (IL-6) | after 2h | 4.61 IU | Standard Deviation 5.04 |
| Group Humigard+Warming Blanket (H+WB) | Cytokine Interleukin-6 (IL-6) | 2h from exsufflation | 29.13 IU | Standard Deviation 24.18 |
| Group Humigard+Warming Blanket (H+WB) | Cytokine Interleukin-6 (IL-6) | 24h after surgery | 27.01 IU | Standard Deviation 25.12 |
| Group Warming Blanket (WB) | Cytokine Interleukin-6 (IL-6) | 24h after surgery | 23.67 IU | Standard Deviation 25.8 |
| Group Warming Blanket (WB) | Cytokine Interleukin-6 (IL-6) | start of surgery | 2.20 IU | Standard Deviation 2.2 |
| Group Warming Blanket (WB) | Cytokine Interleukin-6 (IL-6) | 2h from exsufflation | 25.91 IU | Standard Deviation 22.9 |
| Group Warming Blanket (WB) | Cytokine Interleukin-6 (IL-6) | after 2h | 4.16 IU | Standard Deviation 3.5 |
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
Time frame: changes in cytokine levels just before induction of anesthesia, after 2 h of pneumoperitoneum, 2 h from exsufflation, and 24 h after surgery
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group Humigard+Warming Blanket (H+WB) | Cytokine Tumor Necrosis Factor (TNF)-Beta | start of surgery | 5.74 IU | Standard Deviation 4.8 |
| Group Humigard+Warming Blanket (H+WB) | Cytokine Tumor Necrosis Factor (TNF)-Beta | 2h from exsufflation | 5.44 IU | Standard Deviation 5.3 |
| Group Humigard+Warming Blanket (H+WB) | Cytokine Tumor Necrosis Factor (TNF)-Beta | 24h after surgery | 6.11 IU | Standard Deviation 5.7 |
| Group Humigard+Warming Blanket (H+WB) | Cytokine Tumor Necrosis Factor (TNF)-Beta | after 2h | 5.69 IU | Standard Deviation 5.8 |
| Group Warming Blanket (WB) | Cytokine Tumor Necrosis Factor (TNF)-Beta | 24h after surgery | 7.24 IU | Standard Deviation 6 |
| Group Warming Blanket (WB) | Cytokine Tumor Necrosis Factor (TNF)-Beta | start of surgery | 6.29 IU | Standard Deviation 6.6 |
| Group Warming Blanket (WB) | Cytokine Tumor Necrosis Factor (TNF)-Beta | after 2h | 5.20 IU | Standard Deviation 4.2 |
| Group Warming Blanket (WB) | Cytokine Tumor Necrosis Factor (TNF)-Beta | 2h from exsufflation | 4.90 IU | Standard Deviation 4.5 |
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.
Time frame: 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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group Humigard+Warming Blanket (H+WB) | Postoperative Pain | Patient awakening | 2.5 Units on a scale | Standard Deviation 2.6 |
| Group Humigard+Warming Blanket (H+WB) | Postoperative Pain | At 12 hours | 1.6 Units on a scale | Standard Deviation 1.8 |
| Group Humigard+Warming Blanket (H+WB) | Postoperative Pain | At 24 hours | 1.3 Units on a scale | Standard Deviation 1.5 |
| Group Humigard+Warming Blanket (H+WB) | Postoperative Pain | At 48 hours | 0.6 Units on a scale | Standard Deviation 1.1 |
| Group Warming Blanket (WB) | Postoperative Pain | At 48 hours | 1.1 Units on a scale | Standard Deviation 1.9 |
| Group Warming Blanket (WB) | Postoperative Pain | Patient awakening | 2.3 Units on a scale | Standard Deviation 2.8 |
| Group Warming Blanket (WB) | Postoperative Pain | At 24 hours | 1.8 Units on a scale | Standard Deviation 2.1 |
| Group Warming Blanket (WB) | Postoperative Pain | At 12 hours | 1.9 Units on a scale | Standard Deviation 2.2 |