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

Edyta Ryczek, Judith White, Ruth Louise Poole, Nicola Laura Reeves, Jared Torkington, Grace Carolan-Rees, Edyta Ryczek, Judith White, Ruth Louise Poole, Nicola Laura Reeves, Jared Torkington, Grace Carolan-Rees

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.

Keywords: carbon dioxide; humans; hypothermia; insufflation; laparoscopy; peritoneum; temperature.

Conflict of interest statement

Conflicts of Interest: The authors declare that during the preparation of this manuscript an unrestricted educational grant for a small feasibility study was received from the company (Fisher & Paykel Healthcare). Fisher & Paykel Healthcare had no role in the development of the protocol or the preparation of this manuscript. None of the authors have personal financial interests in the matters discussed in this manuscript.

©Edyta Ryczek, Judith White, Ruth Louise Poole, Nicola Laura Reeves, Jared Torkington, Grace Carolan-Rees. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 20.12.2019.

Figures

Figure 1
Figure 1
The study process with recruitment, data collection, follow-up, and final analysis.

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