Accepted for/Published in: JMIR Research Protocols
Date Submitted: Apr 30, 2019
Open Peer Review Period: May 3, 2019 - May 17, 2019
Date Accepted: Sep 7, 2019
(closed for review but you can still tweet)
Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.
Normothermic Insufflation to Prevent Perioperative Hypothermia and Improve Quality of Recovery in Elective Colectomy Patients: Protocol for a Randomized Controlled Trial
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.
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Copyright
© The authors. All rights reserved. This is a privileged document currently under peer-review/community review (or an accepted/rejected manuscript). Authors have provided JMIR Publications with an exclusive license to publish this preprint on it's website for review and ahead-of-print citation purposes only. While the final peer-reviewed paper may be licensed under a cc-by license on publication, at this stage authors and publisher expressively prohibit redistribution of this draft paper other than for review purposes.