Physiological Effects of Nebulized Salbutamol in Acute Respiratory Failure Patients on HFNC (PENSAFE-HFNC)

Università degli Studi di Ferrara

Status and phase: Not yet enrolling; Phase 3; Phase 2

Conditions: Pneumonia; Acute Respiratory Failure

Treatments: Drug: salbutamol 2.5 mg via vibrating mesh nebulizer (VMN)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06815679

Nebulized Salbutamol and HFNC

Details and patient eligibility

About

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).

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Salbutamol

Experimental group

Description:

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.

Treatment:

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