Complications and risk factors on midline catheters' follow-up about non-ICU patients: study protocol for a multicentre observational study (the midDATA study).


Journal

BMJ open
ISSN: 2044-6055
Titre abrégé: BMJ Open
Pays: England
ID NLM: 101552874

Informations de publication

Date de publication:
18 07 2023
Historique:
medline: 21 7 2023
pubmed: 19 7 2023
entrez: 18 7 2023
Statut: epublish

Résumé

The midline catheter (MC) is an increasingly popular device used commonly for patients with difficult venous access or those who require infusion for more than 6 days. Little is known about complications such as infection, thrombosis or occlusion for inpatient and home care patient. This protocol presents the follow-up of non-intensive care unit patients with an MC. The aim is to identify complications and search for risk factors associated with these complications. A prospective observational design is used for the follow-up of 2000 patients from 13 centres in France. Each practitioner (inserting clinician, anaesthetist nurse, hospital nurse and home nurse) will fill out a logbook to report each care made (eg, number of saline flushes, dress maintenance) on the MC and if any complications occurred. The incidence of complications (ie, infections, thrombosis or occlusions) will be expressed by the total number of events per 1000 catheter days. The period of recruitment began in December 2019 for a duration of 2 years. An extension of the inclusion period of 1 year was obtained. This study received the approval of the Committee for the Protection of Persons of Nord Ouest IV (No EudraCT/ID-RCB : 2019-A02406-51). It was registered at clinical trials (NCT04131088). It is planned to communicate results at conferences and in a peer-reviewed journal. NCT04131088.

Identifiants

pubmed: 37463802
pii: bmjopen-2022-067796
doi: 10.1136/bmjopen-2022-067796
pmc: PMC10357646
doi:

Banques de données

ClinicalTrials.gov
['NCT04131088', 'NCT04131088']

Types de publication

Clinical Trial Protocol Journal Article Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

e067796

Informations de copyright

© 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.

Déclaration de conflit d'intérêts

Competing interests: None declared.

Références

Crit Care Med. 2021 Feb 1;49(2):e140-e150
pubmed: 33372744
Nursing. 2014 Oct;44(10):60-6
pubmed: 25232986
Clin Appl Thromb Hemost. 2019 Jan-Dec;25:1076029619839150
pubmed: 30909723
Infect Control Hosp Epidemiol. 2018 Jul;39(7):875-877
pubmed: 29655373
Infect Dis Health. 2019 Aug;24(3):152-168
pubmed: 31005606
Int J Infect Dis. 2021 Jan;102:220-225
pubmed: 33129962
J Emerg Med. 2016 Sep;51(3):252-8
pubmed: 27397766
J Vasc Interv Radiol. 2002 Oct;13(10):1009-16
pubmed: 12397122
Acta Anaesthesiol Scand. 2020 Mar;64(3):394-399
pubmed: 31823342
Nurs Open. 2021 May;8(3):1292-1300
pubmed: 33372316
J Clin Med. 2019 Jan 26;8(2):
pubmed: 30691137
Am J Infect Control. 2020 Sep;48(9):1108-1110
pubmed: 31812270
Int J Integr Care. 2005;5:e12
pubmed: 16773162
J Vasc Access. 2018 Sep;19(5):492-495
pubmed: 29546782
Ann Intern Med. 2015 Sep 15;163(6 Suppl):S1-40
pubmed: 26369828
J Vasc Access. 2023 Jan;24(1):165-182
pubmed: 34088239
PLoS One. 2021 May 13;16(5):e0251269
pubmed: 33983979
Int J Nurs Pract. 2022 Apr;28(2):e12976
pubmed: 34075655
Pharmacotherapy. 2018 Apr;38(4):476-481
pubmed: 29493791
BMJ Qual Saf. 2019 Sep;28(9):714-720
pubmed: 30886119
JAMA Intern Med. 2022 Jan 1;182(1):50-58
pubmed: 34842905
Eur J Emerg Med. 2014 Feb;21(1):18-23
pubmed: 23880981
Intensive Care Med. 2012 Jul;38(7):1105-17
pubmed: 22614241
Am J Infect Control. 2019 Sep;47(9):1118-1121
pubmed: 31047692
J Vasc Access. 2020 Sep;21(5):764-768
pubmed: 32106761

Auteurs

Yvan Derouin (Y)

Pôle Anesthésie-Réanimation, Service d'Anesthésie Réanimation Chirurgicale, Unité d'accès vasculaires (UnAV), Hôtel Dieu, Centre Hospitalier Universitaire de Nantes, Nantes, France yvan.derouin@etu.univ-nantes.fr.
Nantes Université, Université de Tours, CHU Nantes, INSERM UMR 1246 Methods in Patients-Centered Outcomes and Health Research, Nantes, France.

Aurélie Le Thuaut (A)

Direction de la Recherche, Plateforme de Méthodologie et Biostatistique, Centre Hospitalier Universitaire de Nantes, Nantes, France.

Jérome Dauvergne (J)

Service d'Anesthésie-Réanimation, hôpital Laënnec, Centre Hospitalier Universitaire de Nantes, Nantes, France.
Pole hospitalo-universitaire 2 Institut du thorax et du systeme nerveux, Centre Hospitalier Universitaire de Nantes, Nantes, France.

Raphaël Cinotti (R)

Nantes Université, Université de Tours, CHU Nantes, INSERM UMR 1246 Methods in Patients-Centered Outcomes and Health Research, Nantes, France.
Pôle Anesthésie-Réanimation, Service d'Anesthésie Réanimation Chirurgicale, Hôtel Dieu, Centre Hospitalier Universitaire de Nantes, Nantes, France.

Emmanuelle Cartron (E)

Département universitaire des sciences infirmières de l'Université de Paris Cité, Université de Paris, Paris, France.
ECEVE - UMR-S 1123, Université de Paris Faculté de Santé, Paris, France.

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