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

NCT02586974 | Completed Results

• 1 other identifier: 0052588
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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).

Conditions

Hypothermia

Keywords

CO2 insufflation; robot assisted radical prostatectomy; laparoscopy; hypothermia; cytokine response

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

• 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

• 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

Study Arms (2)

Group H+WB

EXPERIMENTAL

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®)

Device: Humigard

Group WB

NO INTERVENTION

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)

Interventions

Humigard DEVICE

warmed and humidified CO2 insufflation

Group H+WB

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• A.O.U. Città della Salute e della Scienza: lead
• IRCAD - EITS: collaborator

Study Sites (1)

A.O.U. San Giovanni Battista Molinette

Torino, TO, 10126, Italy

Location

MeSH Terms

Conditions

Hypothermia

Condition Hierarchy (Ancestors)

Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Marco Oderda
• Organization: Città della Salute e della Scienza di Torino - Ospedale Molinette

marco.oderda@libero.it

+393479383465

Study Officials

• Paolo Gontero, Prof

  AOU Città della Salute e della Scienza

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD fellow

Study Record Dates

• First Submitted: May 26, 2015
• First Posted: October 27, 2015
• Study Start: September 1, 2015
• Primary Completion: June 1, 2016
• Study Completion: August 1, 2016
• Last Updated: January 30, 2025
• Results First Posted: February 12, 2020

Record last verified: 2025-01

Locations

IT (1)