Physiological Effects of Nebulized Salbutamol in Acute Respiratory Failure Patients on HFNC

Sponsor
Università degli Studi di Ferrara
Study ID
NCT06815679
Phase
PHASE2/PHASE3
Status
Not Yet Recruiting

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Conditions

  • Acute Respiratory Failure
  • Pneumonia

Eligibility Criteria

Sex
ALL
Age
18 Years - 90 Years
Healthy Volunteers
Not accepted

Interventions

  • salbutamol 2.5 mg via vibrating mesh nebulizer (VMN) — DRUG
    To evaluate the patient's respiratory effort, the pressure-time product (PTPes) and the delta of Pes oscillations during inspiration (∆ Pes) will be obtained from the analysis of the Pes curve. Global and regional pulmonary tidal volumes will be evaluated with Electrical Impedance Tomography

Study Details

This is a prospective physiological interventional study that assess the feasibility and safety of administering salbutamol using a vibrating mesh nebulizer during HFNC in patients with acute hypoxemic respiratory failure (AHRF). We evaluate whether this method of salbutamol delivery can reduce inspiratory effort and improve global and regional lung ventilation in AHRF patients. To achieve this, the study will record and analyze the following: esophageal pressure (Pes) curves, global and regional tidal volumes, minute ventilation, and changes in global and regional lung ventilation assessed through Electrical Impedance Tomography (EIT).

Key Dates

First listed
Feb 7, 2025
Start date
Mar 1, 2025
Status verified
Feb 2025
Primary completion
Jan 31, 2026
Completion
Jul 31, 2026

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Salbutamol
    All patients will received ventilatory support with HFNC by adjusting gas flows to 30 L/min with 100% relative humidity, heated to 37 C, adjusting FiO2 levels to maintain SpO2 between 92 and 96%. After 20 min, each patient remaining on ventilatory support with HFNC will receive administration of salbutamol 2.5 mg via the vibrating mesh nebulizer (VMN) (Aerogen Solo®, Aerogen Ltd., Galway, Ireland) positioned immediately downstream of the humidification chamber of the HFNC system, using the dedicated connector.

Primary Outcome Measure

To evaluate the changes of inspiratory effort based on the analysis of the oesophageal pressure curve. [ Time Frame: The measurement of ΔPes will be conducted: After 20 minutes of ventilatory support with HFNC (Time 0) 10 minutes following the completion of Salbutamol administration (Time 1) At 1 hour, 2 hours, and 3 hours post-Salbutamol administration ]

Central Contacts

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