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Distinct physiological effects of high-flow nasal cannula, helmet CPAP, and their combination in acute hypoxemic respiratory failure

Physiological comparison of high-flow nasal cannula, helmet CPAP and their combination in acute hypoxemic respiratory failure: a crossover physiological study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN15358358
Enrollment
18
Registered
2026-06-08
Start date
2024-03-08
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute hypoxemic respiratory failure in ICU patients Respiratory

Interventions

The study was designed as a randomized crossover physiological investigation. The sequence of the three interventions (HFNC, Helmet CPAP, HFNC+CPAP) was randomized using a computer-generated randomiza
Helmet CPAP (H-CPAP) with PEEP 8 cmH2O and total flow 80 L/min
Combined HFNC+CPAP with HFNC delivered inside the helmet. Each intervention lasts 30 minutes. Inspiratory effort, respiratory mechanics, ventilatory pattern, and gas exchange are measured during each

Sponsors

Ospedale Santa Chiara
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1. Adult ICU patients with acute hypoxemic respiratory failure requiring supplemental oxygen therapy to maintain PaO2 >60 mmHg or SpO2 >90%, PaCO2 25 breaths/min 3. Acute onset of symptoms within 7 days of hospital admission 4. Age >18 years

Exclusion criteria

Exclusion criteria: 1. Asthma or COPD exacerbation 2. Cardiogenic pulmonary edema 3. Chronic neuromuscular disease 4. Pulmonary embolism 5. Pregnancy

Design outcomes

Primary

MeasureTime frame
Inspiratory effort measured using Esophageal pressure swing (?Pes) and simplified esophageal pressure–time product per minute (sPTPes/min) measured using esophageal manometry, at each 30-minute intervention phase (HFNC, H-CPAP, HFNC+CPAP)

Secondary

MeasureTime frame
Gas exchange and respiratory mechanics measured using PaO2/FiO2 ratio, venous admixture, PaCO2, respiratory rate, tidal volume, minute ventilation, dynamic transpulmonary driving pressure (?PL), and dynamic lung compliance, at the final 5 minutes of each 30-minute intervention phase.;Ventilatory load measured using the respiratory rate, minute ventilation (Ve), and Ve corrected for PaCO2 at each 30-minute intervention phase;Oxygenation measured using PaO2/FiO2 ratio and venous admixture obtained from arterial blood gas analysis, at the final 5 minutes of each intervention phase;Pneumatic performance of PEEP valves measured using airway pressure swing (?Paw) and correlation between ?Paw and ?Pes using flow-dependent and flow-independent PEEP valves, at H-CPAP and HFNC+CPAP phases;Non-invasive ventilation (NIV) failure measured using data on the need for endotracheal intubation after non-invasive respiratory support, at within 48 hours after study completion;Patient comfort and dyspnea measured using the Borg dyspnea and discomfort scales, at each intervention phase

Countries

Italy

Contacts

Public ContactSergio Lassola
sergio.lassola@asuit.tn.it+390461 902579

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Aug 10, 2026