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)
Normothermic Insufflation to Prevent Perioperative Infection (NIPPI) – Quality of Recovery and perioperative hypothermia in elective colectomy patients: a study protocol for a randomised 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 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:
To determine if insufflation with warmed, humidified CO2 using the HumiGard device, alongside standard perioperative warming techniques, can improve patients’ recovery, including pain, surgical site infections, complications and the use of analgesia, compared to standard care alone.
Methods:
The study is a multicentre, randomised, 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 randomised 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 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 RCT, 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 randomised 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 patients’ adequate body temperature during surgery.
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