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

Last updated: February 3, 2025
Sponsor: Università degli Studi di Ferrara
Overall Status: Active - Not Recruiting

Phase

2/3

Condition

Pneumonia

Lung Injury

Acute Respiratory Distress Syndrome (Ards)

Treatment

salbutamol 2.5 mg via vibrating mesh nebulizer (VMN)

Clinical Study ID

NCT06815679
Nebulized Salbutamol and HFNC
  • Ages 18-90
  • All Genders

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 Criteria

Inclusion

Inclusion Criteria:

  • • Age > 18, < 90 years

  • Non-intubated critically ill patients with AHRF due to pneumonia (diagnosis isbased on the presence of infiltrates on chest X-ray and the onset of clinicalsigns of infection less than 7 days earlier)

  • PaO2/FiO2 ≤ 300 mmHg

  • Patients receiving oxygen therapy

Exclusion

Exclusion Criteria:

  • • Age < 18 years

  • Hypercapnia (PaCO2 > 50 mmHg)

  • Hemodynamic instability (Systolic blood pressure < 90 mmHg or Mean arterialpressure < 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 < 8hours 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

Study Design

Total Participants: 20
Treatment Group(s): 1
Primary Treatment: salbutamol 2.5 mg via vibrating mesh nebulizer (VMN)
Phase: 2/3
Study Start date:
March 01, 2025
Estimated Completion Date:
July 31, 2026

Study Description

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 EIT.

Connect with a study center

  • Azienda ospedaliera Universitaria di Ferrara

    Ferrara, 44121
    Italy

    Site Not Available

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