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Идёт набор NCT07268859

Effect of Fan Application in Preventing Ticagrelor-Associated Dyspnea

Без фазы С лечением Acute Coronary Syndromes Ticagrelor Dyspnea

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: STANDART CARE, STANDART CARE & FAN THERAPY.
Кому может быть актуально
Состояния в реестре: Acute Coronary Syndromes, Ticagrelor, Dyspnea. Базовые параметры: 18 лет — 65 лет · 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
Turkey (Türkiye)
Следующий шаг
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Официальное название

Effect of Fan Application in Preventing Ticagrelor-associated Dyspnea in Patients With Acute Coronary Syndrome.

Обзор

This study will be conducted in the coronary intensive care unit of Dr. Siyami Ersek Chest, Heart and Vascular Surgery Training and Research Hospital. It aims to investigate the effect of hand fan therapy on ticagrelor-associated dyspnea in patients receiving ticagrelor.

Подробное описание

Patients in the coronary intensive care unit receiving ticagrelor and meeting the inclusion criteria will be included. The study includes two groups: a control group receiving standard care and an experimental group receiving standard care plus hand fan therapy. A total of 110 participants (55 per group) will be recruited. Randomization will be performed using a computer-based randomization program. Due to the nature of the intervention and sample characteristics, participants and the researcher will not be blinded. Data will be analyzed by a statistician not involved in the study, and the findings will be reported.

Вмешательства

  • Другое STANDART CARE
    Routine ward care including semi-Fowler position and breathing exercises. Standard institutional care will be applied. Presence, number, and severity of dyspnea attacks will be recorded during the first 2 hours after ticagrelor administration.
  • Другое STANDART CARE & FAN THERAPY
    In addition to standard care, patients will undergo hand fanning for 5 minutes at 30, 60, and 120 minutes after ticagrelor administration. The fan will be directed toward the patient's face from a distance of \~15 cm. Dyspnea severity and number of episodes will be recorded during this period.

Первичные конечные точки

  • Incidence of ticagrelor-associated dyspnea [Срок оценки: Time Frame: 0-120 minutes after ticagrelor administration (T1: baseline; T2: 30 min; T3: 60 min; T4: 120 min) Unit of Measure: Percentage of participants (%)]
Вторичные конечные точки (1)
  • Time to onset of ticagrelor-associated dyspnea [Срок оценки: Time Frame: Within 120 minutes after ticagrelor administration (T1-T4) Unit of Measure: Minutes (min)]

Критерии участия

Критерии включения

  • Between the ages of 18 and 65,
  • No severe hearing and vision problems,
  • Can speak and understand Turkish,
  • Easy to communicate with,
  • First-time sufferer of acute coronary syndrome (ACS) for the first time,
  • Decided to start ticagrelor therapy,
  • Able to adapt to treatment,
  • Individuals who volunteered to participate in the research.

Критерии исключения

  • Having any problem that prevents you from communicating cognitively, emotionally and verbally,
  • Obstructive sleep abnormalities,
  • Have a disease that affects respiratory function (stage IV cancer, bronchial asthma, COVID-19, lung cancer, pulmonary edema, chronic obstructive pulmonary disease, pulmonary hypertension, pulmonary embolism, pneumonia or bronchitis, etc.),
  • With metabolic abnormalities,
  • Intubated after the procedure,
  • Previously treated with ticagrelor,
  • Individuals who did not volunteer to participate in the study. Losses to follow up
  • Individuals who wish to leave the study voluntarily.
  • Saturation value below 95%,
  • The one with the arrest,
  • Who will not be able to fulfill the requirements of the work,
  • Individuals with life-threatening conditions

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Профилактика

Центры проведения

Turkey (Türkiye) · 2 центра
  • İstanbul Üniversitesi-Cerrahapaşa — Istanbul
  • Sağlık Bilimleri Üniversitesi Dr. Siyami Ersek Göğüs Kalp ve Damar Cerrahisi Eğitim Araştı — Istanbul

Идентификаторы

NCT: NCT07268859 · ATADEK2024-10/449 · Is an identifier other

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗