Personalized Noninvasive Support in Acute Hypoxemic Respiratory Failure

NCT06202144 — Not applicable, Completed, 20 participants, Fondazione Policlinico Universitario Agostino Gemelli IRCCS

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Physiological Effects of Personalized Noninvasive Support in Acute Hypoxemic Respiratory Failure

Registry	NCT06202144
Status	Completed
Phase	Not applicable
Study type	Interventional; randomized, crossover, masking: none, treatment
Enrollment	20 (Actual)
Sponsor	Fondazione Policlinico Universitario Agostino Gemelli IRCCS (Other)
Conditions	Acute Hypoxic Respiratory Failure
Interventions	Noninvasive support (Device)
Dates	start 2024-01-12, primary completion 2025-06-01, completion 2025-06-15, first posted 2024-01-11, last updated 2025-09-30
Locations	1 site in Italy

-Summary

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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+Detailed description

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.

+Arms and interventions

Arm	Type	Interventions	Description
Personalized Noninvasive support	Experimental	Device: Noninvasive support	Helmet noninvasive support, with positive end-expiratory pressure (PEEP)=12 cmH2O and the minimal pressure-support level capable of generating inspiratory effort between 5 and 10 cmH2O
Continuous positive airway pressure	Active comparator	Device: Noninvasive support	Helmet CPAP will be delivered through a high-flow generator and PEEP valve set at 12 cmH2O
Noninvasive ventilation	Active comparator	Device: Noninvasive support	Helmet NIV will be delivered in the pressure-support mode, with PEEP=12 cmH2O and pressure support=12 cmH2O

Noninvasive support (Device): Noninvasive respiratory support delivered through a helmet

+Outcome measures

Primary outcomes

Tidal volume [1 hour]: Tidal volume size, assessed with electrical impedance tomography
Transpulmonary driving pressure [1 hour]: The positive inspiratory swing in transpulmonary pressure, calculated as airway pressure minus esophageal pressure

Secondary outcomes

Inspiratory effort [1 hour]: Inspiratory effort, defined as the negative deflection in esophageal pressure
Respiratory rate [1 hour]: Respiratory rate per minute
Blood oxygenation [1 hour]: PaO2/FiO2 ratio
Work of breathing [1 hour]: Simplified esophageal pressure pressure-time product
Corrected minute ventilation [1 hour]: Minute ventilation (assessed with electrical impedance tomography) normalized to PaCO2
Tidal volume distribution [1 hour]: Tidal volume distribution in the four lung regions of interest (ventral, mid-ventral, mid-dorsal and dorsal), assessed with electrical impedance tomography
End-expiratory lung impedance [1 hour]: End-expiratory lung impedance, assessed with electrical impedance tomography
Pendelluft extent [1 hour]: Pendelluft, assessed with electrical impedance tomography and expressed in % of tidal volume size
Lung compliance [1 hour]: Defined as the ration of tidal volume to transpulmonary driving pressure
Dyspnea [1 hour]: Dyspnea, defined through a visual analog scale ((ranging from 0 to 10, with representing most severe dyspnea)

+Eligibility

Sex: All, ages: 18 Years to any

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

+Locations (1)

Facility	City	Country	Status
Fondazione Policlinico Universitaro A. Gemelli IRCCS	Rome	Italy

+Investigators

Domenico Luca Grieco, Principal investigator, Fondazione Policlinico Universitario Agostino Gemelli IRCCS