Evaluation of the Effect of Pulmonary Rehabilitation on Patients With High Flow Oxygen Therapy

Обзор

Evaluation of the effect of pulmonary rehabilitation on patients with high flow oxygen therapy

Подробное описание

Objective: the purpose of this study was to evaluate the effect of lung rehabilitation on patients treated with high flow humidification apparatus in ICU. Methods: 70 patients in ICU who were treated with high flow humidification apparatus from June 2019 to June 2020 were randomly divided into two groups. The experimental group was treated with pulmonary rehabilitation and the control group was treated with routine medical treatment only. All patients were evaluated and measured by bedside diaphragm ultrasound. The vital signs of all patients were monitored every day. MRCsum assessment of peripheral muscle strength, 30s sitting test, modified Barthel index, Borg dyspnea score, arterial blood gas analysis and bedside diaphragm ultrasound monitoring were performed at admission and discharge. Finally, statistics were made on the use of non-invasive ventilator, endotracheal intubation, new complications (pressure sore, aspiration, thrombus, etc.) and the time of patients getting out of bed for the first time.The end point of the experiment was 28 days.

Вмешательства

• Поведенческое Pulmonary rehabilitation therapy
  Comprehensive interventions based on comprehensive evaluation and customization of patients, including, but not limited to, exercise training, education and behavioral changes, aimed at improving the physiological and psychological status of patients with chronic respiratory diseases, and urge patients to adhere to health promotion activities for a long time.

Первичные конечные точки

• MRC [Срок оценки: Day 28]
• STS [Срок оценки: Day 28]
• barthel index [Срок оценки: Day 28]
• Borg dyspnea score [Срок оценки: Day 28]
• PaO2 [Срок оценки: Day 28]
• Oxygenation index [Срок оценки: Day 28]
• Diaphragm mobility [Срок оценки: Day 28]
• Diaphragm contraction velocity [Срок оценки: Day 28]
• End-inspiratory diaphragm thickness [Срок оценки: Day 28]
• End-expiratory diaphragm thickness [Срок оценки: Day 28]

Вторичные конечные точки (7)

• ICU stay time [Срок оценки: 3 month]
• Hospitalization time [Срок оценки: Month 3]
• The time it takes to get out of bed for the first time [Срок оценки: Day 28]
• Use of non-invasive ventilator [Срок оценки: Day 28]
• Intubation [Срок оценки: Day 28]
• mortality [Срок оценки: Day 28]
• Complication [Срок оценки: Day 28]

Критерии участия

Критерии включения

• The age is ≥ 18 years old;
• the hemodynamics is stable;
• 50 < heart rate < 120 beats / min ;
• 90 < systolic blood pressure < 200mmHg ;
• 55 < mean arterial pressure < 120mmHg;
• do not increase the dose of pressor drugs for at least 2 hours;
• intracranial pressure is stable and there are no seizures within 24 hours;
• the respiratory state is stable;
• the patient's finger pulse oxygen saturation ≥ 88%;
• 10 < respiratory frequency < 35 beats / min.

Критерии исключения

• Pregnancy;
• acute cardio-cerebrovascular events;
• spinal or limb fractures;
• active bleeding.

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

Двойное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Chinese PLAGH Hospital — Пекин

Идентификаторы

NCT: NCT04441151 · pulmonary rehabilitation

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗