Physiological Effects of Nebulized Salbutamol in Acute Respiratory Failure Patients on HFNC

Официальное название

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

Обзор

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).

Подробное описание

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.

Вмешательства

• Препарат 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

Первичные конечные точки

• To evaluate the changes of inspiratory effort based on the analysis of the oesophageal pressure curve. [Срок оценки: 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]

Вторичные конечные точки (7)

• Feasibility and safety of administering salbutamol via a vibrating mesh nebulize [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: [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 [Срок оценки: : 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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.]

Критерии участия

Критерии включения

• • 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

Критерии исключения

• • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Италия · 1 центр

• Azienda ospedaliera Universitaria di Ferrara — Ferrara

Публикации

• 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. PMID 38675226
• 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. PMID 36743674
• 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. PMID 37607815

Идентификаторы

NCT: NCT06815679 · Nebulized Salbutamol and HFNC

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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