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Clinical Trials in Italy / NCT06815679
Starting soon Phase 2/3

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

NCT06815679 · tracked via the Priya Life Science Italy tracker
Phase
Phase 2/3
Started
2025-03-01
Last updated
2025-02-07

Condition(s) studied

Acute Respiratory FailurePneumonia

Investigational drug(s) / intervention(s)

salbutamol 2.5 mg via vibrating mesh nebulizer (VMN)

salbutamol 2.5 mg via vibrating mesh nebulizer (VMN): 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 summary

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).

Eligibility

Sex
ALL
Min age
18 Years
Max age
90 Years
Healthy volunteers
No
Inclusion Criteria: * • Age \> 18, \< 90 years * Non-intubated critically ill patients with AHRF due to pneumonia (diagnosis is based on the presence of infiltrates on chest X-ray and the onset of clinical signs of infection less than 7 days earlier) * PaO2/FiO2 ≤ 300 mmHg * Patients receiving oxygen therapy Exclusion Criteria: * • Age \< 18 years * Hypercapnia (PaCO2 \> 50 mmHg) * Hemodynamic instability (Systolic blood pressure \< 90 mmHg or Mean arterial pressure \< 60 or high dose of vasoactive drugs) * Tachycardia or tachyarrhythmia (HR \> 130 b/min) * Known allergy or intolerance to salbutamol * Patient has received inhaled therapy with short-acting beta 2 agonists \< 8 hours before or with long-acting beta 2 agonists \< 24 hours before * Acute exacerbation of COPD or bronchial asthma * Cardiogenic pulmonary edema * GCS ≤ 12 * Contraindication for EIT (e.g. ICD) * Pregnancy * Patient refuses to participate

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Azienda ospedaliera Universitaria di Ferrara Ferrara Italy

More Università degli Studi di Ferrara trials in Italy

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06815679 on ClinicalTrials.gov ↗ ← All trials in Italy