Normothermic Insufflation to Prevent Perioperative Hypothermia and Improve Quality of Recovery in Elective Colectomy Patients: Protocol for a Randomized Controlled Trial

Abstract

Background Perioperative hypothermia during laparoscopy for bowel resection is a risk factor for postoperative medical complications and surgical wound infections. Despite various warming methods used during surgery, a significant number of patients experience perioperative hypothermia. Use of dry, unwarmed insufflation carbon dioxide (CO2) during laparoscopic procedures may contribute to this problem. Evidence exists that the HumiGard device, which humidifies and heats CO2 for insufflation, can reduce the risk of perioperative hypothermia. Objective The aim is to determine if insufflation with warmed, humidified CO2 using the HumiGard device, alongside standard perioperative warming techniques, can improve patient recovery, including pain, surgical site infections, complications, and the use of analgesia compared with standard care alone. Methods The study is a multicenter, randomized, blinded (patient, surgeon, and assessor), sham device-controlled, parallel group-controlled trial of 232 patients. The study aims to recruit patients undergoing elective laparoscopic, segmental, or total colectomy. Patients will be randomized to receive HumiGard plus standard care or standard care alone (1:1 ratio). The primary outcome is patient-reported quality of recovery, measured by the validated QoR-40 (quality of recovery) questionnaire, from baseline to postoperative day 1. Secondary outcomes include postoperative pain, the incidence of hypothermia, and the rate of postoperative complications. Results The information gathered during a small-scale service evaluation at a single hospital was used to inform this study protocol. Before applying for a grant for this full randomized controlled trial, the authors will conduct a feasibility study of 40 patients to ensure that the protocol is feasible and to inform our sample size calculation. Conclusions The randomized controlled trial is designed to provide high-quality evidence on the effectiveness of the HumiGard device in potentially reducing the risk of perioperative hypothermia in patients scheduled for laparoscopic colectomy. The results will be used to improve the maintenance of adequate patient body temperature during surgery. International Registered Report Identifier (IRRID) PRR1-10.2196/14533

Warmed and humidified insufflation to prevent perioperative hypothermia and improve the quality of recovery in elective laparoscopic colorectal resection patients: a feasibility study for a triple‐blind randomized controlled trial

“…This was a feasibility study for a larger RCT [13] to compare the effect of WHCO2 (via HumiGard) with standard care during laparoscopic surgery on patients' postoperative recovery. The aim of the feasibility study was to establish whether recruitment can be achieved and that the study was acceptable to patients and to evaluate potential suitable outcomes including whether the Quality of Recovery-40 (QoR-40) questionnaire was an appropriate tool for measuring patient recovery.…”

“…Full details of the study assessments and flow diagram are described in the published protocol for a full-scale RCT by Ryczek et al [13]. In summary, patient assessments and data collection occurred preoperatively (baseline), intraoperatively and postoperatively at days 1, 3 and 30.…”

Intraoperative Patient Warming Instead of Gas on the Management of Postoperative Pain in Laparoscopic Colectomy and Cholecystectomy: A Randomized Controlled Trial

“…However, alterations in temperature due to carbon dioxide (CO2) insufflation during laparoscopic surgeries appear [2][3][4][5][6]. In addition, warming and humidification of insufflated CO2 gas have been reported in order to reduce the development of hypothermia [7][8][9][10][11].…”

A phase I, nonrandomized controlled trial demonstrating the novel technique of cytoreductive surgery and hyperthermic intraperitoneal chemotherapy utilizing warm humidified carbon dioxide insufflation

“…The procedure exposes the intraperitoneal contents to ambient air for 3-20 h via a generous laparotomy, which in turn may result in surface hypothermia [3]. The extensive surgical dissection during CRS contributes to peritoneal desiccation which, combined with hypothermia, impairs anti-inflammatory and barrier functions resulting in an increased risk of intra-abdominal sepsis and coagulopathy and potentially increased transfusion requirements, cardiac complications and venous thromboembolic events [4][5][6][7][8].…”