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急性低酸素性呼吸不全に対する継続的な負の外圧の生理学的影響

2026年9月28日 更新者：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).

調査の概要

状態

募集

条件

介入・治療

詳細な説明

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.

研究の種類

介入

入学 (推定)

20

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究場所

  • アメリカ
    • New York
      • Brooklyn、New York、アメリカ、11220
        • 募集
        • NYU Langone Health - Brooklyn Hospital
      • New York、New York、アメリカ、10016
        • 募集
        • Bellevue Hospital
      • New York、New York、アメリカ、10032
        • 完了
        • Columbia University Irving Medical Center
      • New York、New York、アメリカ、10016
        • 募集
        • NYU Langone Health - NYU Tisch-Kimmel Hospital

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年歳以上 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

説明

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：処理
  • 割り当て：ランダム化
  • 介入モデル：クロスオーバー割り当て
  • マスキング：なし（オープンラベル）

武器と介入

参加者グループ / アーム
介入・治療
アクティブコンパレータ：HFNCのみ
デバイス：HFNC only

HFNC for 45 minutes, with FiO2 titrated to SpO2 of 90-97%
実験的：HFNC+CNEP10
デバイス：HFNC + CNEP10

HFNC with CNEP of 10 cmH2O for 45 minutes, with FiO2 titrated to SpO2 of 90-97%
実験的：HFNC + CNEP20
デバイス：HFNC + CNEP20

HFNC with CNEP of 20 cmH2O for 45 minutes, with FiO2 titrated to SpO2 of 90-97%
実験的：HFNC+CNEP30
デバイス：HFNC + CNEP30

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

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Change from baseline in SpO2/FiO2
時間枠：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

二次結果の測定

結果測定
メジャーの説明
時間枠
Change from baseline in Respiratory Rate
時間枠：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
時間枠：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)
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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

その他の成果指標

結果測定
メジャーの説明
時間枠
Change from baseline in other components of the Multidimensional Dyspnea Profile
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

NYU Langone Health

捜査官

  • 主任研究者：Jeremy Beitler, MD, MPH、Columbia University

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2024年2月28日

一次修了 (推定)

2027年6月30日

研究の完了 (推定)

2027年6月30日

試験登録日

最初に提出

2022年12月29日

QC基準を満たした最初の提出物

2022年12月29日

最初の投稿 (実際)

2023年1月9日

学習記録の更新

投稿された最後の更新 (実際)

2026年10月1日

QC基準を満たした最後の更新が送信されました

2026年9月28日

最終確認日

2026年9月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • 26-00257

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個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

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はい

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はい

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