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Completed

NCT Number: NCT06202144

Personalized Noninvasive Support in Acute Hypoxemic Respiratory Failure

The optimal noninvasive respiratory support for acute hypoxemic respiratory failure is debated. Recent preliminary data indicate that both pressure-support noninvasive ventilation (NIV) and continuous-positive airway pressure (CPAP) may be of benefit. While often applied interchangeably in clinical practice, NIV and CPAP have different effects on the inspiratory effort, which is the major determinant of self-inflicted lung injury. Also, inspiratory effort widely varies among individuals.

The purpose of this study is to assess the physiological effects of a noninvasive respiratory support approach guided by inspiratory effort, as compared to CPAP and NIV, in patients with moderate-to-severe acute hypoxemic respiratory failure.

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Key information

Conditions

Acute Hypoxic Respiratory Failure

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fondazione Policlinico Universitaro A. Gemelli IRCCS

Rome, Italy

About this study

Patients with acute hypoxemic respiratory failure will undergo a decremental pressure-support trial during helmet noninvasive support. The following pressure-support settings will be applied sequentially, with positive end-expiratory pressure kept constant and equal to 10-12 cmH2O: 20 cmH2O, 16 cmH2O, 12 cmH2O, 8 cmH2O and high-flow-driven CPAP. Inspiratory effort will be monitored during the trial through esophageal manometry. The personalized setting of noninvasive support will be defined as the minimal pressure-support level capable of generating inspiratory effort between 5 and 10 cmH2O.

Personalized noninvasive support will be then compared to conventionally-set NIV and CPAP in a randomized cross-over trial.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Acute hypoxemic respiratory failure and PaO2/FiO2<200 mmHg
  • PaCO2<45 mmHg
  • Respiratory failure not caused by exacerbation of chronic pulmonary disease, cardiac failure or fluid overload

Exclusion criteria

  • Pregnancy
  • Contraindication to helmet support
  • Contraindication to esophageal manometry
  • Contraindication to electrical-impedance tomography monitoring
  • Recent surgery involving the abdomen or the thorax
  • Pneumothorax or documented barotrauma

Treatment and study plan

Noninvasive support

Device

Noninvasive respiratory support delivered through a helmet

Primary outcomes

  1. Tidal volume

    Time frame: 1 hour

    Tidal volume size, assessed with electrical impedance tomography

  2. Transpulmonary driving pressure

    Time frame: 1 hour

    The positive inspiratory swing in transpulmonary pressure, calculated as airway pressure minus esophageal pressure

Secondary outcomes

  1. Inspiratory effort

    Time frame: 1 hour

    Inspiratory effort, defined as the negative deflection in esophageal pressure

  2. Respiratory rate

    Time frame: 1 hour

    Respiratory rate per minute

  3. Blood oxygenation

    Time frame: 1 hour

    PaO2/FiO2 ratio

  4. Work of breathing

    Time frame: 1 hour

    Simplified esophageal pressure pressure-time product

  5. Corrected minute ventilation

    Time frame: 1 hour

    Minute ventilation (assessed with electrical impedance tomography) normalized to PaCO2

  6. Tidal volume distribution

    Time frame: 1 hour

    Tidal volume distribution in the four lung regions of interest (ventral, mid-ventral, mid-dorsal and dorsal), assessed with electrical impedance tomography

  7. End-expiratory lung impedance

    Time frame: 1 hour

    End-expiratory lung impedance, assessed with electrical impedance tomography

  8. Pendelluft extent

    Time frame: 1 hour

    Pendelluft, assessed with electrical impedance tomography and expressed in % of tidal volume size

  9. Lung compliance

    Time frame: 1 hour

    Defined as the ration of tidal volume to transpulmonary driving pressure

  10. Dyspnea

    Time frame: 1 hour

    Dyspnea, defined through a visual analog scale ((ranging from 0 to 10, with representing most severe dyspnea)

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Registry information

Official study title

Physiological Effects of Personalized Noninvasive Support in Acute Hypoxemic Respiratory Failure

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jan 11, 2024
Registry last updated
Sep 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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