Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT06815679

Physiological Effects of Nebulized Salbutamol in Acute Respiratory Failure Patients on 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).

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Acute Respiratory Failure Infections Lung Diseases Pneumonia Respiratory Tract Diseases Respiratory Tract Infections

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Azienda ospedaliera Universitaria di Ferrara

Ferrara, 44121, Italy

Location contact

Savino Spadaro, Associate Professor

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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)

  2. 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)

  3. 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)

  4. 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)

  5. 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 (%).

  6. 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.

  7. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Carlo Alberto Volta, Professor

CONTACT

[email protected]

Savino Spadaro, Associate professor

CONTACT

[email protected]

+39 0532 293111

Sponsors and collaborators

Lead sponsor

Università degli Studi di Ferrara

Other

Collaborators

  • Aerogen

Registry information

Official study title

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

Acronym: PENSAFE-HFNC

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Feb 7, 2025
Registry last updated
Feb 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.