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Not yet recruiting NCT06815679

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

Phase II / Phase III Interventional Acute Respiratory Failure Pneumonia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: salbutamol 2.5 mg via vibrating mesh nebulizer (VMN).
Who it may be relevant to
Registry conditions: Acute Respiratory Failure, Pneumonia. Basic parameters: 18 years — 90 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

The Physiological Effects of Nebulized Salbutamol in Patients With Acute Respiratory Failure During HFNC

Overview

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).

Detailed 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.

Interventions

  • Drug 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

Primary outcome measures

  • 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]
Secondary outcome measures (7)
  • Feasibility and safety of administering salbutamol via a vibrating mesh nebulize [Time frame: Data Collection Points: Baseline (prior to Salbutamol administration). During nebulization. Post-nebulization at 10 minutes, 1 hour, 2 hours, and 3 hours.]
  • Feasibility and safety of administering salbutamol via a vibrating mesh nebulize To evaluate the feasibility and safety of administering salbutamol via a vibrating mesh nebulizer during HFNC in patients with AHRF. The safety evaluation involves identif [Time frame: Data Collection Points: Baseline (prior to Salbutamol administration). During nebulization. Post-nebulization at 10 minutes, 1 hour, 2 hours, and 3 hours.]
  • Feasibility and safety of administering salbutamol via a vibrating mesh nebulize [Time frame: [Time Frame: Data Collection Points: Baseline (prior to Salbutamol administration). During nebulization. Post-nebulization at 10 minutes, 1 hour, 2 hours, and 3 hours.]]
  • Feasibility and safety of administering salbutamol via a vibrating mesh nebulize [Time frame: : Baseline (prior to Salbutamol administration). During nebulization. Post-nebulization at 10 minutes, 1 hour, 2 hours, and 3 hours.]]
  • Evaluation of global and regional ventilation by EIT [Time frame: Data Collection Points: Baseline (before Salbutamol administration) during HFNC therapy. Post-Salbutamol: 10 minutes (early phase of response) 1 hour, 2 hours, and 3 hours after Salbutamol administration.]
  • Evaluation of global and regional ventilation by EIT [Time frame: Data Collection Points: Baseline (before Salbutamol administration) during HFNC therapy. Post-Salbutamol: 10 minutes (early phase of response) 1 hour, 2 hours, and 3 hours after Salbutamol administration.]
  • Evaluation of global and regional ventilation by EIT [Time frame: Data Collection Points: Baseline (before Salbutamol administration) during HFNC therapy. Post-Salbutamol: 10 minutes (early phase of response) 1 hour, 2 hours, and 3 hours after Salbutamol administration.]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Italy · 1 center
  • Azienda ospedaliera Universitaria di Ferrara — Ferrara

Publications

  • MacLoughlin R, Mac Giolla Eain M. Performance Characterisation of the Airvo2TM Nebuliser Adapter in Combination with the Aerogen SoloTM Vibrating Mesh Nebuliser for in Line Aerosol Therapy during High Flow Nasal Oxygen Therapy. Pharmaceutics. 2024 Apr 20;16(4):565. doi: 10.3390/pharmaceutics16040565. PMID 38675226
  • Calabrese C, Annunziata A, Mariniello DF, Allocca V, Imitazione P, Cauteruccio R, Simioli F, Fiorentino G. Aerosol delivery through high-flow nasal therapy: Technical issues and clinical benefits. Front Med (Lausanne). 2023 Jan 18;9:1098427. doi: 10.3389/fmed.2022.1098427. eCollection 2022. PMID 36743674
  • Arunsurat I, Rittayamai N, Chuaychoo B, Tangchityongsiva S, Promsarn S, Yuenyong S, Chow CW, Brochard L. Bronchodilator Efficacy of High-Flow Nasal Cannula in COPD: Vibrating Mesh Nebulizer Versus Jet Nebulizer. Respir Care. 2024 Jan 24;69(2):157-165. doi: 10.4187/respcare.11139. PMID 37607815

Identifiers

NCT: NCT06815679 · Nebulized Salbutamol and HFNC

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗