Clinical trial NCT06815679: Physiological Effects of Nebulized Salbutamol in Acute Respiratory Failure Patients on HFNC
Official title: The Physiological Effects of Nebulized Salbutamol in Patients With Acute Respiratory Failure During HFNC
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
PHASE3
Conditions: Acute Respiratory Failure
Pneumonia
Keywords: salbutamol
acute respiratory failure
high flow nasal cannalae
aerosol delivery
Lead sponsor: Università degli Studi di Ferrara
Sponsor class: OTHER
Collaborators: name: Aerogen
First posted: 2025-02-07
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).

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.

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

Primary outcomes:
measure: To evaluate the changes of inspiratory effort based on the analysis of the oesophageal pressure curve.
timeFrame: 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:
measure: Feasibility and safety of administering salbutamol via a vibrating mesh nebulize
timeFrame: Data Collection Points: Baseline (prior to Salbutamol administration). During nebulization. Post-nebulization at 10 minutes, 1 hour, 2 hours, and 3 hours.
measure: 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
timeFrame: Data Collection Points: Baseline (prior to Salbutamol administration). During nebulization. Post-nebulization at 10 minutes, 1 hour, 2 hours, and 3 hours.
measure: Feasibility and safety of administering salbutamol via a vibrating mesh nebulize
timeFrame: [Time Frame: Data Collection Points: Baseline (prior to Salbutamol administration). During nebulization. Post-nebulization at 10 minutes, 1 hour, 2 hours, and 3 hours.]
measure: Feasibility and safety of administering salbutamol via a vibrating mesh nebulize
timeFrame: : Baseline (prior to Salbutamol administration). During nebulization. Post-nebulization at 10 minutes, 1 hour, 2 hours, and 3 hours.]
measure: Evaluation of global and regional ventilation by EIT
timeFrame: 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.
measure: Evaluation of global and regional ventilation by EIT
timeFrame: 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.
measure: Evaluation of global and regional ventilation by EIT
timeFrame: 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.
Other outcomes:
Locations:
city: Ferrara
country: Italy
facility: Azienda ospedaliera Universitaria di Ferrara
Study officials:
affiliation: Università degli Studi di Ferrara
name: Carlo Alberto Volta, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.