Feasibility of closed-loop titration of norepinephrine infusion in patients undergoing moderate- and high-risk surgery.
Aged
Anesthesia
Blood Pressure
/ drug effects
Elective Surgical Procedures
Equipment Design
Feasibility Studies
Female
Humans
Hypertension
/ chemically induced
Hypotension
/ chemically induced
Infusions, Intravenous
/ instrumentation
Male
Middle Aged
Norepinephrine
/ administration & dosage
Surgical Procedures, Operative
/ methods
Treatment Outcome
Vasoconstrictor Agents
/ adverse effects
closed-loop
haemodynamic
hypertension
hypotension
norepinephrine
perioperative care
vasopressor agents
Journal
British journal of anaesthesia
ISSN: 1471-6771
Titre abrégé: Br J Anaesth
Pays: England
ID NLM: 0372541
Informations de publication
Date de publication:
Oct 2019
Oct 2019
Historique:
received:
22
02
2019
revised:
09
04
2019
accepted:
08
05
2019
pubmed:
1
7
2019
medline:
21
9
2019
entrez:
1
7
2019
Statut:
ppublish
Résumé
Vasopressor agents are used to prevent intraoperative hypotension and ensure adequate perfusion. Vasopressors are usually administered as intermittent boluses or manually adjusted infusions, but this practice requires considerable time and attention. We have developed a closed-loop vasopressor (CLV) controller to correct hypotension more efficiently. Here, we conducted a proof-of-concept study to assess the feasibility and performance of CLV control in surgical patients. Twenty patients scheduled for elective surgical procedures were included in this study. The goal of the CLV system was to maintain MAP within 5 mm Hg of the target MAP by automatically adjusting the rate of a norepinephrine infusion using MAP values recorded continuously from an arterial catheter. The primary outcome was the percentage of time that patients were hypotensive, as defined by a MAP of 5 mm Hg below the chosen target. Secondary outcomes included the total dose of norepinephrine, percentage of time with hypertension (MAP>5 mm Hg of the chosen target), raw percentage "time in target" and Varvel performance criteria. The 20 subjects (median age: 64 years [52-71]; male (35%)) underwent elective surgery lasting 154 min [124-233]. CLV control maintained MAP within ±5 mm Hg of the target for 91.6% (85.6-93.3) of the intraoperative period. Subjects were hypotensive for 2.6% of the intraoperative period (range, 0-8.4%). Additional performance criteria for the controller included mean absolute performance error of 2.9 (0.8) and mean predictive error of 0.5 (1.0). No subjects experienced major complications. In this proof of concept study, CLV control minimised perioperative hypotension in subjects undergoing moderate- or high-risk surgery. Further studies to demonstrate efficacy are warranted. NCT03515161 (ClinicalTrials.gov).
Sections du résumé
BACKGROUND
BACKGROUND
Vasopressor agents are used to prevent intraoperative hypotension and ensure adequate perfusion. Vasopressors are usually administered as intermittent boluses or manually adjusted infusions, but this practice requires considerable time and attention. We have developed a closed-loop vasopressor (CLV) controller to correct hypotension more efficiently. Here, we conducted a proof-of-concept study to assess the feasibility and performance of CLV control in surgical patients.
METHODS
METHODS
Twenty patients scheduled for elective surgical procedures were included in this study. The goal of the CLV system was to maintain MAP within 5 mm Hg of the target MAP by automatically adjusting the rate of a norepinephrine infusion using MAP values recorded continuously from an arterial catheter. The primary outcome was the percentage of time that patients were hypotensive, as defined by a MAP of 5 mm Hg below the chosen target. Secondary outcomes included the total dose of norepinephrine, percentage of time with hypertension (MAP>5 mm Hg of the chosen target), raw percentage "time in target" and Varvel performance criteria.
RESULTS
RESULTS
The 20 subjects (median age: 64 years [52-71]; male (35%)) underwent elective surgery lasting 154 min [124-233]. CLV control maintained MAP within ±5 mm Hg of the target for 91.6% (85.6-93.3) of the intraoperative period. Subjects were hypotensive for 2.6% of the intraoperative period (range, 0-8.4%). Additional performance criteria for the controller included mean absolute performance error of 2.9 (0.8) and mean predictive error of 0.5 (1.0). No subjects experienced major complications.
CONCLUSIONS
CONCLUSIONS
In this proof of concept study, CLV control minimised perioperative hypotension in subjects undergoing moderate- or high-risk surgery. Further studies to demonstrate efficacy are warranted.
TRIAL REGISTRY NUMBER
UNASSIGNED
NCT03515161 (ClinicalTrials.gov).
Identifiants
pubmed: 31255290
pii: S0007-0912(19)30443-X
doi: 10.1016/j.bja.2019.04.064
pmc: PMC6972231
pii:
doi:
Substances chimiques
Vasoconstrictor Agents
0
Norepinephrine
X4W3ENH1CV
Banques de données
ClinicalTrials.gov
['NCT03515161']
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
430-438Subventions
Organisme : NHLBI NIH HHS
ID : R01 HL144692
Pays : United States
Informations de copyright
Copyright © 2019 British Journal of Anaesthesia. Published by Elsevier Ltd. All rights reserved.
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