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Физиологические эффекты постоянного отрицательного внешнего давления при острой гипоксической дыхательной недостаточности

28 сентября 2026 г. обновлено: NYU Langone Health

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).

Обзор исследования

Статус

Рекрутинг

Условия

Вмешательство/лечение

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.

Тип исследования

Интервенционный

Регистрация (Оцененный)

20

Фаза

  • Непригодный

Контакты и местонахождение

В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.

Контакты исследования

Места учебы

  • Соединенные Штаты
    • New York
      • Brooklyn, New York, Соединенные Штаты, 11220
        • Рекрутинг
        • NYU Langone Health - Brooklyn Hospital
      • New York, New York, Соединенные Штаты, 10016
        • Рекрутинг
        • Bellevue Hospital
      • New York, New York, Соединенные Штаты, 10032
        • Завершенный
        • Columbia University Irving Medical Center
      • New York, New York, Соединенные Штаты, 10016
        • Рекрутинг
        • NYU Langone Health - NYU Tisch-Kimmel Hospital

Критерии участия

Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.

Критерии приемлемости

Возраст, подходящий для обучения

18 лет и старше (Взрослый, Пожилой взрослый)

Принимает здоровых добровольцев

Нет

Полы, имеющие право на обучение

Все

Описание

Inclusion Criteria:

  1. Age 18 years or older
  2. Acute hypoxemic respiratory failure
  3. Non-cardiogenic airspace opacities on chest radiograph or computed tomography (CT) scan
  4. High-flow nasal cannula (flow ≥ 30 LPM) initiated within last 96 hours (4 days)
  5. FiO2 ≥ 40%
  6. SpO2 ≥ 92%

Exclusion Criteria:

  1. Do-not-intubate order

  2. Anatomical factor predisposing to poor fit of cuirass (e.g. severe kyphosis or scoliosis)

  3. Use of cuirass precluded, e.g. due to:

    • Clinically prescribed prone positioning
    • Tense ascites
    • Severe abdominal pain
    • Abdominal wound or surgery, symptomatic abdominal aortic aneurysm, or other unstable or high-risk intra-abdominal pathology
    • Pregnancy
    • Agitated delirium
    • Body weight > 180 kg
    • Burned skin or draining wounds under the planed cuirass area
    • Indwelling tube/drain entry sites within the planned cuirass seat path

  4. Prior intubation during hospital stay

  5. Cardiogenic pulmonary edema

  6. Exacerbation of asthma or COPD

  7. 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

  8. Glasgow coma score < 15

  9. Chest tube, pneumothorax, or pneumomediastinum

  10. Hemodynamic instability, defined as any of:

    • Heart rate < 50 beats/minute
    • Mean arterial pressure < 55 mmHg
    • Norepinephrine-equivalent vasopressor requirement > 0.1mcg/kg/min

  11. Implantable electrical device (e.g. pacemaker, defibrillator, neurostimulator)

  12. Unreliable pulse-oximetry tracing

  13. Imminent intubation

  14. 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)

  15. Attending physician refusal

  16. Lack of capacity for direct consent

Учебный план

В этом разделе представлена ​​подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.

Как устроено исследование?

Детали дизайна

  • Основная цель: Уход
  • Распределение: Рандомизированный
  • Интервенционная модель: Назначение кроссовера
  • Маскировка: Нет (открытая этикетка)

Оружие и интервенции

Группа участников / Армия
Вмешательство/лечение
Активный компаратор: Только HFNC
Устройство: HFNC only

HFNC for 45 minutes, with FiO2 titrated to SpO2 of 90-97%
Экспериментальный: ВФНК + CNEP10
Устройство: HFNC + CNEP10

HFNC with CNEP of 10 cmH2O for 45 minutes, with FiO2 titrated to SpO2 of 90-97%
Экспериментальный: ВФНК + CNEP20
Устройство: HFNC + CNEP20

HFNC with CNEP of 20 cmH2O for 45 minutes, with FiO2 titrated to SpO2 of 90-97%
Экспериментальный: ВФНК + CNEP30
Устройство: HFNC + CNEP30

HFNC with CNEP of 30 cmH2O for 45 minutes, with FiO2 titrated to SpO2 of 90-97%

Что измеряет исследование?

Первичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Change from baseline in SpO2/FiO2
Временное ограничение: At the end of each treatment period, up to 45 minutes

The change in SpO2/FiO2 within each participant as measured at baseline and at the end of each treatment assignment period. The average SpO2/FiO2 over the last five minutes of the treatment period will be used.
At the end of each treatment period, up to 45 minutes

Вторичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Change from baseline in Respiratory Rate
Временное ограничение: At the end of each treatment period, up to 45 minutes

The change in Respiratory Rate within each participant as measured at baseline and at the end of each treatment assignment period. The average Respiratory Rate over the last five minutes of the treatment period will be used.
At the end of each treatment period, up to 45 minutes
Change from baseline in ROX Index
Временное ограничение: At the end of each treatment period, up to 45 minutes

The change in ROX index within each participant as measured at baseline and at the end of each treatment assignment period. ROX index is calculated as SpO2/FiO2 divided by the Respiratory Rate. The average ROX index over the last five minutes of the treatment period will be used.
At the end of each treatment period, up to 45 minutes
Change from baseline in Transcutaneous Carbon Dioxide (CO2)
Временное ограничение: At the end of each treatment period, up to 45 minutes

The change in Transcutaneous Carbon Dioxide within each participant as measured at baseline and at the end of each treatment assignment period. The average Transcutaneous Carbon Dioxide over the last five minutes of the treatment period will be used.
At the end of each treatment period, up to 45 minutes
Change from baseline in Heart Rate
Временное ограничение: At the end of each treatment period, up to 45 minutes

The change in Heart Rate within each participant as measured at baseline and at the end of each treatment assignment period. The average Heart Rate over the last five minutes of the treatment period will be used.
At the end of each treatment period, up to 45 minutes
Change from baseline in Blood Pressure
Временное ограничение: At the end of each treatment period, up to 45 minutes

The change in Blood Pressure within each participant as measured at baseline and at the end of each treatment assignment period. The average Blood Pressure over the last five minutes of the treatment period will be used.
At the end of each treatment period, up to 45 minutes
Change from baseline in Breathing Discomfort
Временное ограничение: At the end of each treatment period, up to 45 minutes

The change in Breathing Discomfort within each participant as measured at baseline and at the end of each treatment assignment period. Breathing Discomfort will be measured with component A1 of the Multidimensional Dyspnea Profile.
At the end of each treatment period, up to 45 minutes
Change from baseline in Lightheadedness
Временное ограничение: At the end of each treatment period, up to 45 minutes

The change in Lightheadedness within each participant as measured at baseline and at the end of each treatment assignment period. Lightheadedness will be measured with an ordinal scale ranging from 0 to 10.
At the end of each treatment period, up to 45 minutes
Change from baseline in Nausea
Временное ограничение: At the end of each treatment period, up to 45 minutes

The change in Nausea within each participant as measured at baseline and at the end of each treatment assignment period. Nausea will be measured with an ordinal scale ranging from 0 to 10.
At the end of each treatment period, up to 45 minutes
Change from baseline in Skin Discomfort
Временное ограничение: At the end of each treatment period, up to 45 minutes

The change in patient-reported Skin Discomfort as measured at baseline and at the end of each treatment assignment period. Skin Discomfort will be measured with an ordinal scale ranging from 0 to 10.
At the end of each treatment period, up to 45 minutes
Change from baseline in Skin Erythema
Временное ограничение: At the end of each treatment period, up to 45 minutes

The change in Skin Erythema within each participant as measured at baseline and at the end of each treatment assignment period. Skin erythema will be measured by investigator visual assessment using a five-point scale.
At the end of each treatment period, up to 45 minutes
Tolerance of intervention period
Временное ограничение: For the duration of each treatment period, up to 45 minutes

Patient able to complete the entire treatment period of intervention without early discontinuation for intolerance
For the duration of each treatment period, up to 45 minutes
Proportion of time within 3 cm H2O of target CNEP level
Временное ограничение: For the duration of each treatment period, up to 45 minutes

Ability to reach and maintain the target CNEP level, defined as CNEP within ± 3 cm H2O of the prescribed value
For the duration of each treatment period, up to 45 minutes
Proportion of time within 5 cm H2O of target CNEP level
Временное ограничение: For the duration of each treatment period, up to 45 minutes

Ability to reach and maintain the target CNEP level, defined as CNEP within ± 5 cm H2O of the prescribed value
For the duration of each treatment period, up to 45 minutes

Другие показатели результатов

Мера результата
Мера Описание
Временное ограничение
Change from baseline in other components of the Multidimensional Dyspnea Profile
Временное ограничение: At end of study

The change in other components of the Multidimensional Dyspnea Profile within each participant as measured at baseline and at the end of the study. At end of study, participants will be instructed to consider their breathing on average during CNEP to obtain the post-baseline measure.
At end of study
Change from baseline in Tidal Volume
Временное ограничение: At the end of each treatment period, up to 45 minutes

The change in Tidal Volume within each participant as measured at baseline and at the end of each treatment assignment period, estimated from lung electrical impedance tomography. The average Tidal Volume over the last five minutes of the treatment period will be used.
At the end of each treatment period, up to 45 minutes
Change from baseline in End-Expiratory Lung Volume
Временное ограничение: At the end of each treatment period, up to 45 minutes

The change in End-Expiratory Lung Volume within each participant as estimated from end-expiratory lung impedance measured at baseline and at the end of each treatment assignment period. The average End-Expiratory Lung Impedance over the last five minutes of the treatment period will be used to derive change in end-expiratory lung volume.
At the end of each treatment period, up to 45 minutes
Change from baseline in Minute Ventilation
Временное ограничение: At the end of each treatment period, up to 45 minutes

The change in Minute Ventilation within each participant as measured at baseline and at the end of each treatment assignment period, estimated from lung electrical impedance tomography. The average Minute Ventilation over the last five minutes of the treatment period will be used.
At the end of each treatment period, up to 45 minutes
Change from baseline in Anteroposterior Ventilation Ratio
Временное ограничение: At the end of each treatment period, up to 45 minutes

The change in Anteroposterior Ventilation Ratio within each participant as measured at baseline and at the end of each treatment assignment period, estimated from lung electrical impedance tomography. The average Anteroposterior Ventilation Ratio over the last five minutes of the treatment period will be used.
At the end of each treatment period, up to 45 minutes

Соавторы и исследователи

Здесь вы найдете людей и организации, участвующие в этом исследовании.

Спонсор

NYU Langone Health

Следователи

  • Главный следователь: Jeremy Beitler, MD, MPH, Columbia University

Даты записи исследования

Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.

Изучение основных дат

Начало исследования (Действительный)

28 февраля 2024 г.

Первичное завершение (Оцененный)

30 июня 2027 г.

Завершение исследования (Оцененный)

30 июня 2027 г.

Даты регистрации исследования

Первый отправленный

29 декабря 2022 г.

Впервые представлено, что соответствует критериям контроля качества

29 декабря 2022 г.

Первый опубликованный (Действительный)

9 января 2023 г.

Обновления учебных записей

Последнее опубликованное обновление (Действительный)

1 октября 2026 г.

Последнее отправленное обновление, отвечающее критериям контроля качества

28 сентября 2026 г.

Последняя проверка

1 сентября 2026 г.

Дополнительная информация

Термины, связанные с этим исследованием

Ключевые слова

Дополнительные соответствующие термины MeSH

Другие идентификационные номера исследования

  • 26-00257

Планирование данных отдельных участников (IPD)

Планируете делиться данными об отдельных участниках (IPD)?

НЕТ

Информация о лекарствах и устройствах, исследовательские документы

Изучает лекарственный продукт, регулируемый FDA США.

Нет

Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.

Да

продукт, произведенный в США и экспортированный из США.

Да

Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .

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