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Набор скоро начнётся NCT07730034

Early Postoperative Physiotherapy to Prevent Respiratory Insufficiency After Elective Heart Surgery

Без фазы С лечением CABG Respiratory Insufficiency Postoperative Pulmonary Complications (PPCs)

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: Early postoperative physiotherapy, Standard postoperative care.
Кому может быть актуально
Состояния в реестре: CABG, Respiratory Insufficiency, Postoperative Pulmonary Complications (PPCs). Базовые параметры: 18 лет — 80 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
Хорватия
Следующий шаг
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Официальное название

Early Postoperative Physiotherapy in the Prevention Respiratory Insufficiency After Elective Heart Surgery

Обзор

This study aims to determine whether starting respiratory physiotherapy one hour after removal of the breathing tube following elective coronary artery bypass graft (CABG) surgery leads to better recovery than the current standard approach, in which physiotherapy begins on the first postoperative day. The study will evaluate whether earlier physiotherapy improves lung function, reduces postoperative pulmonary complications, shortens intensive care unit and hospital stay, decreases pain and anxiety, and improves overall recovery after surgery. The main question is whether very early postoperative respiratory physiotherapy provides additional benefits for patients recovering from elective heart surgery compared with standard postoperative care.

Подробное описание

This study is designed to evaluate the effectiveness of early postoperative physiotherapy initiated one hour after extubation in patients undergoing elective coronary artery bypass graft (CABG) surgery. Postoperative pulmonary complications remain among the most frequent causes of morbidity following cardiac surgery and may contribute to prolonged intensive care unit and hospital stay, delayed functional recovery, and increased healthcare utilization. Early physiotherapy has been recognized as an important component of postoperative rehabilitation; however, the optimal timing for its initiation has not been clearly established. This study aims to investigate whether initiating physiotherapy one hour after extubation provides additional clinical benefits compared with the current standard practice of commencing physiotherapy on the first postoperative day. The protocol includes standardized perioperative management and physiotherapy procedures to ensure consistency of the intervention and outcome assessment. The study will be conducted at the University Hospital Centre Zagreb in accordance with the principles of Good Clinical Practice, the Declaration of Helsinki, and applicable ethical and regulatory requirements.

Вмешательства

  • Процедура Early postoperative physiotherapy
    Participants receive an early postoperative physiotherapy protocol initiated within the first 24 hours after elective cardiac surgery. The intervention includes breathing exercises, airway clearance techniques, early mobilization, progressive ambulation, and individualized therapeutic exercises according to a standardized protocol in addition to standard postoperative care.
  • Процедура Standard postoperative care
    Participants receive standard postoperative care, including routine postoperative physiotherapy according to institutional practice without the structured early physiotherapy protocol.

Первичные конечные точки

  • Change in Forced Expiratory Volume in One Second (FEV1) [Срок оценки: From baseline (preoperative) until hospital discharge (approximately up to 21 days after surgery)]
Вторичные конечные точки (11)
  • Change in Peak Expiratory Flow (PEF) [Срок оценки: Baseline (preoperative), postoperative day 1, and before hospital discharge (approximately up to 21 days after surgery).]
  • Postoperative pulmonary complications [Срок оценки: From surgery until hospital discharge (approximately up to 21 days after surgery).]
  • Change in Forced Expiratory Volume (FEV) [Срок оценки: Baseline (preoperative), postoperative day 1, and before hospital discharge (approximately up to 21 days after surgery).]
  • Length of intensive care unit (ICU) stay [Срок оценки: From ICU admission until ICU discharge (approximately up to 21 days after surgery).]
  • Pain intensity [Срок оценки: Baseline (preoperative), postoperative day 1, and before hospital discharge (approximately up to 21 days after surgery).]
  • Title Anxiety and stress [Срок оценки: Baseline (preoperative) and before hospital discharge (approximately up to 21 days after surgery)]
  • Level of alertness and sedation [Срок оценки: Before extubation; after physiotherapy on postoperative day 0 (when applicable); and before and after physiotherapy on postoperative day 1.]
  • Arterial oxygen partial pressure (PaO₂) [Срок оценки: Before extubation; after physiotherapy on postoperative day 0 (when applicable); and before and after physiotherapy on postoperative day 1.]
  • Arterial carbon dioxide partial pressure (PaCO₂) [Срок оценки: Before extubation; after physiotherapy on postoperative day 0 (when applicable); and before and after physiotherapy on postoperative day 1.]
  • Six-minute walk test (6MWT) distance [Срок оценки: Before hospital discharge (approximately up to 21 days after surgery)]
  • Lower limb muscle strength [Срок оценки: Baseline (preoperative) and before hospital discharge (approximately up to 21 days after surgery)]

Критерии участия

Критерии включения

  • Adults aged 18-80 years
  • Male and female participants
  • Elective coronary artery bypass grafting (CABG)
  • Body mass index (BMI) < 30 kg/m²
  • Left ventricular ejection fraction (EF) > 25%
  • Extubated on postoperative day 0 (POD 0)
  • Able and willing to provide written informed consent
  • Able to perform spirometry and follow study instructions

Критерии исключения

  • Refusal or inability to provide informed consent
  • Emergency CABG surgery
  • Previous cardiac surgery
  • Severe cardiac arrhythmias (e.g., ventricular tachycardia/fibrillation, third-degree atrioventricular block)
  • Previous stroke
  • Motor impairment of upper or lower extremities due to neurological or musculoskeletal disease
  • Dyskinesia
  • Not extubated on POD 0
  • Significant postoperative neurological complications
  • Peripheral arterial disease of the lower extremities or previous lower-limb amputation
  • Acute or chronic pulmonary disease
  • Preoperative FEV1 <30% of predicted (greater than 70% reduction)
  • Inability to perform spirometry correctly
  • Cancelled surgery after preoperative assessment
  • Extubation later than 24 hours after surgery
  • Requirement for continuous positive airway pressure (CPAP) after extubation SpO₂ <90% one hour after extubation despite oxygen supplementation (4 L/min by nasal cannula)
  • Return to the operating room after the initial CABG procedure
  • Requirement for dialysis (acute or chronic)

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Лечение

Центры проведения

Хорватия · 1 центр
  • University Hospital Centre Zagreb — Zagreb

Идентификаторы

NCT: NCT07730034 · 02/013 AG

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗