Physiological Effects of Nebulized Salbutamol in Acute Respiratory Failure Patients on HFNC
Trial statusNot yet recruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18-90
SponsorUniversità degli Studi di Ferrara
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
• 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
Disqualifiers
• 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)
Trial design
Design model
Single group
Treatments tested in this trial
salbutamol 2.5 mg via vibrating mesh nebulizer (VMN)
DrugTo 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
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: SalbutamolExperimental treatment 1 intervention
Trial outcomes
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.
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 administrationSecondary outcomes
1
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 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)
Time frame
Data Collection Points: Baseline (prior to Salbutamol administration). During nebulization. Post-nebulization at 10 minutes, 1 hour, 2 hours, and 3 hours.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
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)
Time frame
Data Collection Points: Baseline (prior to Salbutamol administration). During nebulization. Post-nebulization at 10 minutes, 1 hour, 2 hours, and 3 hours.3
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 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
[Time Frame: Data Collection Points: Baseline (prior to Salbutamol administration). During nebulization. Post-nebulization at 10 minutes, 1 hour, 2 hours, and 3 hours.]4
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. Patient Tolerance: Document patient comfort scale (from 1 to 10)
Time frame
: Baseline (prior to Salbutamol administration). During nebulization. Post-nebulization at 10 minutes, 1 hour, 2 hours, and 3 hours.]Sponsors and contacts
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Università degli Studi di Ferrara
Lead sponsor
Aerogen
Collaborator
Source ClinicalTrials.gov
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