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

NCT06815679 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: Nebulized Salbutamol and HFNC
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Acute Respiratory Failure; Pneumonia

Keywords

salbutamol; acute respiratory failure; high flow nasal cannalae; aerosol delivery

Outcome Measures

Primary Outcomes (1)

• To evaluate the changes of inspiratory effort based on the analysis of the oesophageal pressure curve.

  Our hypothesis is based on changes of inspiratory effort, based on the analysis of the delta esophageal pressure (ΔPes), after the administration of Salbutamol by via a vibrating mesh nebulizer during HFNC in patients with AHRF. Evaluating the delta esophageal pressure (ΔPes) requires careful measurement of esophageal pressure (Pes) during the respiratory cycle. ΔPes specifically reflects the inspiratory effort or the work of breathing (WOB), as it measures the difference between the maximum inspiratory and expiratory Pes values during each breath.

  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 Outcomes (7)

• Feasibility and safety of administering salbutamol via a vibrating mesh nebulize

  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

  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: 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

  : 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

  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.

Study Arms (1)

Salbutamol

EXPERIMENTAL

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.

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

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

Salbutamol

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Università degli Studi di Ferrara: lead
• Aerogen: collaborator

Study Sites (1)

Azienda ospedaliera Universitaria di Ferrara

Ferrara, 44121, Italy

Location

Related Publications (3)

• 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 RESULT

• 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 RESULT

• 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 RESULT

MeSH Terms

Conditions

Pneumonia

Interventions

Albuterol

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Phenethylamines; Ethylamines

Study Officials

• Carlo Alberto Volta, Professor

  Università degli Studi di Ferrara

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Savino Spadaro, Associate professor

CONTACT

+39 0532 293111; spdsvn@unife.it

Carlo Alberto Volta, Professor

CONTACT

vlc@unife.it

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 9, 2025
• First Posted: February 7, 2025
• Study Start: March 1, 2025
• Primary Completion: January 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: February 7, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)