Acute Respiratory Failure, Pneumonia
Conditions
Keywords
salbutamol, acute respiratory failure, high flow nasal cannalae, aerosol delivery
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.
Interventions
DRUGsalbutamol 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
Sponsors
Aerogen
Università degli Studi di Ferrara
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To evaluate the changes of inspiratory effort based on the analysis of the oesophageal pressure curve. | 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
| Measure | Time frame | Description |
|---|---|---|
| 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. | 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) |
| 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. | 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) |
| 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. | 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 (%). |
Countries
Italy
Contacts
Primary ContactSavino Spadaro, Associate professor
Backup ContactCarlo Alberto Volta, Professor
Outcome results
None listed