Personalized Noninvasive Support in Acute Hypoxemic Respiratory Failure

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-12

Study Completion Date

2025-06-15

Brief Summary

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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

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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.

Conditions

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Acute Hypoxic Respiratory Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Personalized 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

Group Type EXPERIMENTAL

Noninvasive support

Intervention Type DEVICE

Noninvasive respiratory support delivered through a helmet

Continuous positive airway pressure

Helmet CPAP will be delivered through a high-flow generator and PEEP valve set at 12 cmH2O

Group Type ACTIVE_COMPARATOR

Noninvasive support

Intervention Type DEVICE

Noninvasive respiratory support delivered through a helmet

Noninvasive ventilation

Helmet NIV will be delivered in the pressure-support mode, with PEEP=12 cmH2O and pressure support=12 cmH2O

Group Type ACTIVE_COMPARATOR

Noninvasive support

Intervention Type DEVICE

Noninvasive respiratory support delivered through a helmet

Interventions

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Noninvasive support

Noninvasive respiratory support delivered through a helmet

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No