Is it safe for patients who have undergone an elective ECV in the AMC, to spend the first evening and night alone at home, without additional supervision?
ID
Bron
Verkorte titel
Aandoening
Atrium fibrillation
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
The number of patients with complications related to the anaesthesia or the ECV procedure between 0-2 and 2-24 hours after the procedure.
Achtergrond van het onderzoek
Electrical cardioversion (ECV) is an effective treatment for patients with AF, restoring sinus rhythm in approximately 90% of cases.The Amsterdam University Medical Center (Amsterdam UMC), location AMC, treats more than 500 patients with an elective ECV, per year. If the patients feel well enough, they are discharged to their home environment, under supervision for the first evening and night.
Research question
Is it safe for patients who have undergone an elective ECV in the AMC, to spend the first evening and night alone at home, without additional supervision?
For this retrospective outcome analysis, “safe” is defined as the absence of complications related to the anaesthesia or the cardioversion, in the first 24 hours after the ECV procedure.
Doel van het onderzoek
Is it safe for patients who have undergone an elective ECV in the AMC, to spend the first evening and night alone at home, without additional supervision?
Onderzoeksopzet
Timepoint 1: Baseline measurements: cardiac rate, rhythm, and other cardiac variables, before ECV.
Timepoint 2: 0-2 hours after ECV: cardiac rate and rhythm, adverse events or complications, their type, severity, treatment, and outcome, measured until discharge from hospital.
Timepoint 3: 2-24 hours: any adverse events or complications as a result of the anesthesia or ECV, their type, severity, treatment, and outcome, measured from discharge until 24 hours after ECV.
Timepoint 4: 30 days: Any adverse events or complications as a result of the anesthesia or ECV, their type, severity, treatment, and outcome, measured between 24 hours and one month after the procedure.
Onderzoeksproduct en/of interventie
None, observational
Publiek
Femke Piersma
020 566 3794
f.r.piersma@amsterdamumc.nl
Wetenschappelijk
Femke Piersma
020 566 3794
f.r.piersma@amsterdamumc.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
- Patients who underwent ECV in Amsterdam UMC, location AMC in 2019 and 2020
- Patients > 18 years
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
- Patients who completed an objection to the re-use of care data.
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiënten Data (IPD)
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
Register | ID |
---|---|
NTR-new | NL9433 |
Ander register | METC Amsterdam UMC, location AMC : W21_151#21.166, confirmed as non-WMO study |