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Идёт набор NCT04915261

A Randomized Trial of Lenient Versus Strict Arm Instruction Post Cardiac Device Surgery

Фаза IV С лечением Post-Op Complication

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Lenient Arm Restriction, Strict Arm Restriction.
Кому может быть актуально
Состояния в реестре: Post-Op Complication. Базовые параметры: Без ограничений · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Канада
Следующий шаг
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Официальное название

A Randomized Trial of Lenient Versus Strict Arm Instruction Post Cardiac Device Surgery - LENIENT

Обзор

The purpose and objectives of this study is to investigate whether reducing the existing arm restrictions on patients who receive Cardiac Implantable Electronic Devices (CIED) will result in an improved patient experience post operatively and reduce complication rates. There are multiple and varied arm restriction instructions given to patients receiving CIED's with limited universally accepted protocols or advice on restrictions for patients following surgery. Restrictions such as arm immobilization, showering and weight lifting, in addition to contradictory advice between various hospitals and physicians, can negatively affect patient quality of life and increase patient anxiety with no current evidence for benefit. A cluster cross over randomized trial has been designed to test the comparative effectiveness of lenient vs strict arm restrictions for all patients receiving implantable devices. Instructions within both arms of this study are considered within reasonable practice in Canada. All arm restriction instructions and parameters will be embedded within EPIC, nurses will teach the restriction in addition they will be provide to the patients via printed EPIC discharge summaries. Further links will be embedded in the After Visit Summary (AFS) printouts and my Chart for patients in EPIC. These instructions will be changed every 8 months, as per the crossover design of the trial. Additionally, both arms will utilize interactive voice recognition (IVR) to provide patients with further reminders and instruction on arm restrictions. All patients are given standard of care instructions for follow up and complication assessment through the investigators' device clinic and 24/7 on call nursing program.

Подробное описание

The purpose and objectives of this study is to investigate whether reducing the existing restrictions on patients post CIED will result in an improved patient experience post operatively and reduce complication rates. Results from this study will create standardized, postoperative arm restriction recommendations more uniform between various hospitals.

Hypothesis: The investigators hypothesize that outcomes of the post CIED implanted patients given lenient arm restriction will be non-inferior to those with prolonged arm restriction at reducing a combined primary endpoint of lead dislodgement, device infection, clinically significant pocket hematoma, upper limb DVT and frozen shoulder.

Clinical relevance: The investigators anticipate that patients with minimal (lenient) arm restriction will have similar postoperative complication rates compared to the prolonged arm restriction. Should this hypothesis be proven, this will greatly improve patient quality of life post CIED with less stringent restrictions.

Вмешательства

  • Поведенческое Lenient Arm Restriction
    The study will crossover between either strict arm restriction guidelines for patients or lenient arm restrictions.
  • Поведенческое Strict Arm Restriction
    The study will crossover between either strict arm restriction guidelines for patients or lenient arm restrictions.

Первичные конечные точки

  • A composite of 1) Lead dislodgement 2) Frozen shoulder 3) Upper arm venous thrombosis 4) Clinically significant hematoma formation [Срок оценки: 1 year]
Вторичные конечные точки (3)
  • Rate of hematoma [Срок оценки: 1 year]
  • Rate of lead dislodgement [Срок оценки: 1 year]
  • Rate of frozen shoulder [Срок оценки: 1 year]

Критерии участия

Критерии включения

  • all patients undergoing device surgery which includes implantation of at least one new endovascular lead

Критерии исключения

  • Standalone CIED generator replacement
  • Subcutaneous implantable cardioverter defibrillators
  • Leadless endocardial pacemakers
  • Temporary permanent pacemakers

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Перекрёстный дизайн
Маскирование
Открытое
Основная цель
Профилактика

Центры проведения

Канада · 1 центр
  • University of Ottawa Heart Institute — Ottawa

Публикации

  • Golian M, Sadek MM, Aydin A, Davis D, Green M, Klein A, Nair GM, Nery P, Ramirez FD, Redpath C, Hansom SP, Wells GA, Birnie DH. A Randomized Trial of Lenient Versus Strict Arm Instruction Post Cardiac Device Surgery (LENIENT). Am Heart J. 2023 May;259:52-57. doi: 10.1016/j.ahj.2023.01.016. Epub 2023 Jan 25. PMID 36708911

Идентификаторы

NCT: NCT04915261 · 20210168-01H

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗