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Physiologische Auswirkungen eines kontinuierlichen negativen Außendrucks bei akuter hypoxämischer Ateminsuffizienz

28. September 2026 aktualisiert von: 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).

Studienübersicht

Status

Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Geschätzt)

20

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studienorte

  • Vereinigte Staaten
    • New York
      • Brooklyn, New York, Vereinigte Staaten, 11220
        • Rekrutierung
        • NYU Langone Health - Brooklyn Hospital
      • New York, New York, Vereinigte Staaten, 10016
        • Rekrutierung
        • Bellevue Hospital
      • New York, New York, Vereinigte Staaten, 10032
        • Abgeschlossen
        • Columbia University Irving Medical Center
      • New York, New York, Vereinigte Staaten, 10016
        • Rekrutierung
        • NYU Langone Health - NYU Tisch-Kimmel Hospital

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Crossover-Aufgabe
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Aktiver Komparator: Nur HFNC
Gerät: HFNC only

HFNC for 45 minutes, with FiO2 titrated to SpO2 of 90-97%
Experimental: HFNC + CNEP10
Gerät: HFNC + CNEP10

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

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

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

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change from baseline in SpO2/FiO2
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change from baseline in Respiratory Rate
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Andere Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change from baseline in other components of the Multidimensional Dyspnea Profile
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

NYU Langone Health

Ermittler

  • Hauptermittler: Jeremy Beitler, MD, MPH, Columbia University

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

28. Februar 2024

Primärer Abschluss (Geschätzt)

30. Juni 2027

Studienabschluss (Geschätzt)

30. Juni 2027

Studienanmeldedaten

Zuerst eingereicht

29. Dezember 2022

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

29. Dezember 2022

Zuerst gepostet (Tatsächlich)

9. Januar 2023

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

1. Oktober 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

28. September 2026

Zuletzt verifiziert

1. September 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • 26-00257

Plan für individuelle Teilnehmerdaten (IPD)

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Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Ja

Produkt, das in den USA hergestellt und aus den USA exportiert wird

Ja

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