Physiology of Helmet vs. Facemask Noninvasive Ventilation

NCT06210386 | Completed

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

Brief Summary

The optimal noninvasive management of acute hypoxemic respiratory failure is debated. Helmet noninvasive ventilation may be more effective than facemask noninvasive ventilation for these patients. Putatitve benefits of helmet use are the possibility to apply significantly higher positive end-expiratory pressure without air leaks and with good patient's comfort. In this randomized crossover study, the investigators will assess the physiological effects of helmet compared to facemask noninvasive ventilation, with the latter applied with different ventilator settings (similar to or different from helmet settings).

Conditions

Acute Hypoxemic Respiratory Failure

Outcome Measures

Primary Outcomes (2)

• Inspiratory effort

  negative deflection in esophageal pressure

  1 hour

• End-expiratory lung impedance

  Electrical-impedance derived end-expiratory lung volume

  1 hour

Secondary Outcomes (12)

• Tidal volume

  1 hour

• Work of breathing

  1 hour

• Respiratory rate

  1 hour

• Dynamic transpulmonary driving pressure

  1 hour

• Compliance

  1 hour

Study Arms (3)

Helmet noninvasive ventilation

EXPERIMENTAL

1-hour treatment with helmet noninvasive ventilation (PEEP 12 cmH2O + pressure support 10 cmH2O).

Device: Noninvasive ventilation

Facemask noninvasive ventilation (facemask settings)

ACTIVE COMPARATOR

1-hour treatment with facemask noninvasive ventilation (PEEP 5 cmH2O + pressure support 10 cmH2O).

Device: Noninvasive ventilation

Facemask noninvasive ventilation (helmet settings)

ACTIVE COMPARATOR

1-hour treatment with facemask noninvasive ventilation (PEEP 12 cmH2O + pressure support 10 cmH2O).

Device: Noninvasive ventilation

Interventions

Noninvasive ventilation DEVICE

noninvasive ventilation

Facemask noninvasive ventilation (facemask settings); Facemask noninvasive ventilation (helmet settings); Helmet noninvasive ventilation

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 or facemask noninvasive ventilation
• 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

MeSH Terms

Conditions

Respiratory Insufficiency

Interventions

Noninvasive Ventilation

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Officials

• Domenico L. Grieco, MD

  Fondazione Policlinico 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

Model Details: Crossover randomized trial

Study Record Dates

• First Submitted: January 2, 2024
• First Posted: January 18, 2024
• Study Start: January 19, 2024
• Primary Completion: July 31, 2025
• Study Completion: September 15, 2025
• Last Updated: September 30, 2025

Record last verified: 2025-09

Locations

IT (1)