Personalized Noninvasive Support in Acute Hypoxemic Respiratory Failure

Physiological Effects of 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.

Study Overview

• Status: Completed
• Conditions: Acute Hypoxic Respiratory Failure
• Intervention / Treatment: Device: Noninvasive support

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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Rome, Italy
    • Fondazione Policlinico Universitaro A. Gemelli IRCCS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Device: Noninvasive support; Noninvasive respiratory support delivered through a helmet
Active Comparator: Continuous positive airway pressure; Helmet CPAP will be delivered through a high-flow generator and PEEP valve set at 12 cmH2O	Device: Noninvasive support; Noninvasive respiratory support delivered through a helmet
Active Comparator: Noninvasive ventilation; Helmet NIV will be delivered in the pressure-support mode, with PEEP=12 cmH2O and pressure support=12 cmH2O	Device: Noninvasive support; Noninvasive respiratory support delivered through a helmet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tidal volume	Tidal volume size, assessed with electrical impedance tomography	1 hour
Transpulmonary driving pressure	The positive inspiratory swing in transpulmonary pressure, calculated as airway pressure minus esophageal pressure	1 hour

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Investigators: Principal Investigator: Domenico Luca Grieco, Fondazione Policlinico Universitario A. Gemelli, IRCCS

Study record dates

Study Major Dates

• Study Start (Actual): January 12, 2024
• Primary Completion (Actual): June 1, 2025
• Study Completion (Actual): June 15, 2025

Study Registration Dates

• First Submitted: January 2, 2024
• First Submitted That Met QC Criteria: January 2, 2024
• First Posted (Actual): January 11, 2024

Study Record Updates

• Last Update Posted (Estimated): September 30, 2025
• Last Update Submitted That Met QC Criteria: September 29, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Respiratory Insufficiency
• Other Study ID Numbers: 5173-2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Data will be made available upon reasonable request

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No