Personalized Noninvasive Support in Acute Hypoxemic Respiratory Failure

NCT06202144 | Completed

• 1 other identifier: 5173-2
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Acute Hypoxic Respiratory Failure

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (10)

• Inspiratory effort

  1 hour

• Respiratory rate

  1 hour

• Blood oxygenation

  1 hour

• Work of breathing

  1 hour

• Corrected minute ventilation

  1 hour

Study Arms (3)

Personalized Noninvasive support

EXPERIMENTAL

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

Continuous positive airway pressure

ACTIVE COMPARATOR

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

Device: Noninvasive support

Noninvasive ventilation

ACTIVE COMPARATOR

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

Device: Noninvasive support

Interventions

Noninvasive support DEVICE

Noninvasive respiratory support delivered through a helmet

Continuous positive airway pressure; Noninvasive ventilation; Personalized Noninvasive support

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Fondazione Policlinico Universitaro A. Gemelli IRCCS

Rome, Italy

Location

Study Officials

• Domenico Luca Grieco

  Fondazione Policlinico Universitario A. Gemelli, IRCCS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 2, 2024
• First Posted: January 11, 2024
• Study Start: January 12, 2024
• Primary Completion: June 1, 2025
• Study Completion: June 15, 2025
• Last Updated: September 30, 2025

Record last verified: 2025-09

Locations

IT (1)