Physiological Effects of Continuous Negative External Pressure for Acute Hypoxemic Respiratory Failure
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: HFNC only, HFNC + CNEP10, HFNC + CNEP20, HFNC + CNEP30.
- Кому может быть актуально
- Состояния в реестре: Acute Hypoxemic Respiratory Failure. Базовые параметры: от 18 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
- США
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Не всё понятно в терминах? Прочитайте наш гид для пациентов →
Официальное название
Physiological Effects of Continuous Negative External Pressure for Acute Hypoxemic Respiratory Failure: A Pilot Crossover Trial
Обзор
This study is being conducted to evaluate if wearing a non-invasive breathing support device over the chest/abdomen improves markers of breathing in patients with lung injury requiring high-flow oxygen. The breathing support device consists of a plastic shell that sits over the chest and abdomen and connects to a vacuum that helps the chest expand with breathing. This breathing support is known as continuous negative external pressure (CNEP). Study findings will help determine if this breathing support device might be useful for patients with acute hypoxemic respiratory failure (AHRF).
Подробное описание
This study is a prospective randomized cross-over trial. Eligible, consenting participants will undergo 4 strategies of respiratory support: high-flow nasal cannula (HFNC) only, HFNC + continuous negative external pressure (CNEP) of 10 cmH2O, HFNC + CNEP of 20 cmH2O, HFNC + CNEP of 30 cmH2O. Throughout the study period, HFNC will be managed at a constant flow rate with fraction of inspired oxygen (FiO2) titrated to achieve goal oxygen saturation (SpO2) of 90-97%, measured via continuous pulse-oximetry. Each of the 4 strategies will be performed for 45 minutes per strategy, interspersed with a 15-minute washout period of HFNC only. Participants will be randomized to the sequence of strategies for respiratory support.
A summary of the sequence of trial procedures is as follows:
1. Perform baseline measures. 2. Wait 5-10 minutes for recovery. 3. Initiate first random treatment assignment for up to 45 minutes. 4. HFNC-only washout for 15 minutes 5. Initiate second random treatment assignment for up to 45 minutes. 6. HFNC-only washout for 15 minutes 7. Initiate third random treatment assignment for up to 45 minutes. 8. HFNC-only washout for 15 minutes 9. Initiate fourth random treatment assignment for up to 45 minutes. 10. Return to usual care (HFNC only)
If a participant does not tolerate a given level of CNEP, the patient will be returned to HFNC for 5 minutes and then given the option to attempt that CNEP level again. If the patient declines reattempt or does not tolerate that CNEP level on reattempt, the HFNC-only washout will be instituted for 15 minutes before proceeding to the next protocol step.
Вмешательства
- Устройство HFNC only
HFNC for 45 minutes, with FiO2 titrated to SpO2 of 90-97% - Устройство HFNC + CNEP10
HFNC with CNEP of 10 cmH2O for 45 minutes, with FiO2 titrated to SpO2 of 90-97% - Устройство HFNC + CNEP20
HFNC with CNEP of 20 cmH2O for 45 minutes, with FiO2 titrated to SpO2 of 90-97% - Устройство HFNC + CNEP30
HFNC with CNEP of 30 cmH2O for 45 minutes, with FiO2 titrated to SpO2 of 90-97%
Первичные конечные точки
- Change from baseline in SpO2/FiO2 [Срок оценки: At the end of each treatment period, up to 45 minutes]
Вторичные конечные точки (12)
- Change from baseline in Respiratory Rate [Срок оценки: At the end of each treatment period, up to 45 minutes]
- Change from baseline in ROX Index [Срок оценки: At the end of each treatment period, up to 45 minutes]
- Change from baseline in Transcutaneous Carbon Dioxide (CO2) [Срок оценки: At the end of each treatment period, up to 45 minutes]
- Change from baseline in Heart Rate [Срок оценки: At the end of each treatment period, up to 45 minutes]
- Change from baseline in Blood Pressure [Срок оценки: At the end of each treatment period, up to 45 minutes]
- Change from baseline in Breathing Discomfort [Срок оценки: At the end of each treatment period, up to 45 minutes]
- Change from baseline in Lightheadedness [Срок оценки: At the end of each treatment period, up to 45 minutes]
- Change from baseline in Nausea [Срок оценки: At the end of each treatment period, up to 45 minutes]
- Change from baseline in Skin Discomfort [Срок оценки: At the end of each treatment period, up to 45 minutes]
- Change from baseline in Skin Erythema [Срок оценки: At the end of each treatment period, up to 45 minutes]
- Tolerance of intervention period [Срок оценки: For the duration of each treatment period, up to 45 minutes]
- Proportion of time within 3 cm H2O of target CNEP level [Срок оценки: For the duration of each treatment period, up to 45 minutes]
Критерии участия
Критерии включения
- Age 18 years or older
- Acute hypoxemic respiratory failure
- Non-cardiogenic airspace opacities on chest radiograph or computed tomography (CT) scan
- High-flow nasal cannula (flow ≥ 30 LPM) initiated within last 96 hours (4 days)
- FiO2 ≥ 40%
- SpO2 ≥ 92%
Критерии исключения
- Do-not-intubate order
- Anatomical factor predisposing to poor fit of cuirass (e.g. severe kyphosis or scoliosis)
- Use of cuirass precluded, e.g. due to:
- Clinically prescribed prone positioning
- Tense ascites
- Severe abdominal pain
- Abdominal wound or surgery
- Pregnancy
- Agitated delirium
- Prior intubation during hospital stay
- Cardiogenic pulmonary edema
- Exacerbation of asthma or COPD
- Chronic lung disease, including:
- Interstitial lung disease
- Cystic fibrosis
- Lung mass, lung cancer, or metastasis to the lung
- Lung transplant recipient
- Any disease that requires home oxygen
- Glasgow coma score < 15
- Chest tube, pneumothorax, or pneumomediastinum
- Hemodynamic instability (mean arterial pressure < 55 mmHg or norepinephrine-equivalent vasopressor requirement > 0.1mcg/kg/min)
- Implantable electrical device (e.g. pacemaker, defibrillator, neurostimulator)
- Unreliable pulse-oximetry tracing
- Imminent intubation
- Anticipated lack of patient availability to complete study procedures (e.g. due to planned clinical procedure such as CT scan or dialysis during potential time of study)
- Attending physician refusal
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Перекрёстный дизайн
- Маскирование
- Открытое
- Основная цель
- Лечение
Центры проведения
США · 1 центр
- Columbia University Irving Medical Center — New York
Идентификаторы
NCT: NCT05675345 · AAAT7361