PeRiOperative Glucose PRAgMatic (PROGRAM) trial protocol and statistical analysis plan for comparing automated intraoperative reminders to standardise insulin administration in surgical patients at high risk of hyperglycaemia.

Autor:	Zapf M; Department of Anesthesiology, Vanderbilt University Medical Center, Nashville, Tennessee, USA matthew.a.zapf@vumc.org., Patel D; Department of Anesthesiology, Vanderbilt University Medical Center, Nashville, Tennessee, USA., Henson P; Department of Anesthesiology, Vanderbilt University Medical Center, Nashville, Tennessee, USA., McEvoy MD; Department of Anesthesiology, Vanderbilt University Medical Center, Nashville, Tennessee, USA., Huang E; Department of Pediatric Surgery, Vanderbilt University Medical Center, Nashville, Tennessee, USA., Wanderer JP; Department of Anesthesiology, Vanderbilt University Medical Center, Nashville, Tennessee, USA., Fowler L; Department of Anesthesiology, Vanderbilt University Medical Center, Nashville, Tennessee, USA., Mccarthy K; Department of Anesthesiology, Vanderbilt University Medical Center, Nashville, Tennessee, USA., Freundlich RE; Department of Anesthesiology, Vanderbilt University Medical Center, Nashville, Tennessee, USA., Eden S; Department of Biostatistics, Vanderbilt University Medical Center, Nashville, Tennessee, USA., Shotwell MS; Department of Biostatistics, Vanderbilt University Medical Center, Nashville, Tennessee, USA., Kertai MD; Department of Anesthesiology, Vanderbilt University Medical Center, Nashville, Tennessee, USA.
Jazyk:	angličtina
Zdroj:	BMJ open [BMJ Open] 2023 Aug 24; Vol. 13 (8), pp. e072745. Date of Electronic Publication: 2023 Aug 24.
DOI:	10.1136/bmjopen-2023-072745
Abstrakt:	Introduction: Studies finding perioperative hyperglycaemia is associated with adverse patient outcomes in surgical procedures spurred the development of blood glucose guidelines at many institutions. In this trial, we will assess the implementation of a clinical decision support tool that is integrated into the intraoperative portion of our electronic health record and provides real-time best practice recommendations for intraoperative insulin dosing in surgical patients at high risk for hyperglycaemia. Methods and Design: We will assess this intervention using a sequential and repeated cross-over design at the institutional level with periods of time for wash-out, control and study intervention. The unit of analysis will be the surgical case. The primary outcome will be the frequency of hyperglycaemia (>180 mg/dL (10 mmol/L)) at first postoperative anaesthesia care unit measurement. There are several prespecified secondary analyses focused on perioperative glycaemic control. Discussion: This protocol and statistical analysis plan describes the methodology, primary and secondary analyses. The PeRiOperative Glucose PRAgMatic (PROGRAM) trial was approved by the Vanderbilt University Institutional Review Board (IRB), Vanderbilt University Medical Center, Nashville, Tennessee, USA (IRB, 220991). The study results will be disseminated via publication in a peer-reviewed journal and presented at national scientific conferences. The results of PROGRAM trial will inform best practice for perioperative standardised insulin administration in surgical patients at high risk of hyperglycaemia. Trial Registration Number: NCT05426096. Competing Interests: Competing interests: None declared. (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)
Databáze:	MEDLINE
Externí odkaz:	Zobrazit plný text záznamu