Normothermic Insufflation to Prevent Perioperative Hypothermia and Improve Quality of Recovery in Elective Colectomy Patients: Protocol for a Randomized Controlled Trial.
carbon dioxide
humans
hypothermia
insufflation
laparoscopy
peritoneum
temperature
Journal
JMIR research protocols
ISSN: 1929-0748
Titre abrégé: JMIR Res Protoc
Pays: Canada
ID NLM: 101599504
Informations de publication
Date de publication:
20 Dec 2019
20 Dec 2019
Historique:
received:
30
04
2019
accepted:
07
09
2019
revised:
03
09
2019
entrez:
21
12
2019
pubmed:
21
12
2019
medline:
21
12
2019
Statut:
epublish
Résumé
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 (CO The aim is to determine if insufflation with warmed, humidified CO 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. 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. 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. PRR1-10.2196/14533.
Sections du résumé
BACKGROUND
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 (CO
OBJECTIVE
OBJECTIVE
The aim is to determine if insufflation with warmed, humidified CO
METHODS
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
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
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)
UNASSIGNED
PRR1-10.2196/14533.
Identifiants
pubmed: 31859685
pii: v8i12e14533
doi: 10.2196/14533
pmc: PMC6942176
doi:
Types de publication
Journal Article
Langues
eng
Pagination
e14533Informations de copyright
©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.
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