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

February 3, 2025 updated by: Savino Spadaro, Università degli Studi di Ferrara

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

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).

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Savino Spadaro, Associate professor
  • Phone Number: +39 0532 293111
  • Email: spdsvn@unife.it

Study Contact Backup

Study Locations

  • Italy
      • Ferrara, Italy, 44121
        • Azienda Ospedaliera Universitaria Di Ferrara
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Salbutamol
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)
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.

To evaluate the feasibility and safety of administering salbutamol via a vibrating mesh nebulizer during HFNC in patients with AHRF. The safety evaluation involves identifying and mitigating potential risks associated with the intervention.

Monitor patients for known side effects of Salbutamol, such as:

Tachycardia (>100bpm) Arrhythmias (identified by bpm; millisecond)

Continuously monitor:

Heart rate (to detect tachycardia; bpm)
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.
To evaluate the feasibility and safety of administering salbutamol via a vibrating mesh nebulizer during HFNC in patients with AHRF. The safety evaluation involves identifying and mitigating potential risks associated with the intervention. Hypokalemia (definied <3.0 to 3.4 mEq/L)
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.]
To evaluate the feasibility and safety of administering salbutamol via a vibrating mesh nebulizer during HFNC in patients with AHRF. The safety evaluation involves identifying and mitigating potential risks associated with the intervention. Record any exacerbation of respiratory distress or intolerance to the nebulization process. Continuously monitor: Oxygen saturation (SpO₂,%) and respiratory rate (to ensure adequate oxygenation and ventilation)
[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.]
To evaluate the feasibility and safety of administering salbutamol via a vibrating mesh nebulizer during HFNC in patients with AHRF. Patient Tolerance: Document patient comfort scale (from 1 to 10)
: 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.

To evaluate the improvement of global and regional ventilation based on data obtained with EIT after the administration of salbutamol via a vibrating mesh nebulizer during HFNC in patients with AHRF. EIT provides real-time, non-invasive monitoring of ventilation by measuring regional changes in electrical impedance within the thorax. Parameters to Monitor with EIT: Global Ventilation: Overall changes in lung ventilation during tidal breathing.

Regional Ventilation Distribution in percentage in tidal volume (%).
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.

To evaluate the improvement of regional ventilation based on data obtained with EIT after the administration of salbutamol via a vibrating mesh nebulizer during HFNC in patients with AHRF. Regional Ventilation Delay (RVD) Definition: Measures the time delay in the filling of different lung regions during inhalation.

Unit: Milliseconds (ms) or as a percentage of the respiratory cycle.
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.

To evaluate the improvement of regional ventilation based on data obtained with EIT after the administration of salbutamol via a vibrating mesh nebulizer during HFNC in patients with AHRF. Center of Ventilation (CoV) Definition: Describes the gravity-dependent distribution of ventilation from ventral (front) to dorsal (back) lung regions.

Unit: Percentage (%), representing the shift in ventilation
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Università degli Studi di Ferrara

Collaborators

Aerogen

Investigators

  • Principal Investigator: Carlo Alberto Volta, Professor, Università degli Studi di Ferrara

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2025

Primary Completion (Estimated)

January 1, 2026

Study Completion (Estimated)

July 1, 2026

Study Registration Dates

First Submitted

January 9, 2025

First Submitted That Met QC Criteria

February 3, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 3, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Nebulized Salbutamol and HFNC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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