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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE2/PHASE3

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-01

Study Completion Date

2026-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Effects of Inhaled Nitric Oxide in the Treatment of Acute Hypoxemic Respiratory Failure (AHRF) in Pediatrics

NCT00041561

Respiratory Insufficiency Anoxemia

TERMINATED PHASE3

Relief of Acute Bronchoconstriction/Asthma Using the Non-Invasive AlphaCore Device

NCT01532817

Asthma

COMPLETED NA

Early High-flow Oxygen Therapy With nebuLized Beta-2-agonist Using a Vibrating Mesh for the Management of Moderate to Severe Asthma Exacerbation in the Emergency Department

NCT05691218

Moderate Asthma Exacerbation Severe Asthma Exacerbation

RECRUITING NA

Hypertonic Saline Inhalation in Acute Bronchiolitis

NCT03880903

Acute Bronchiolitis

UNKNOWN PHASE4

Aerosol Inhalation Treatment for Dyspnea

NCT01440764

Healthy Dyspnea

COMPLETED PHASE1/PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Acute Respiratory Failure Pneumonia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Salbutamol

All patients will received ventilatory support with HFNC by adjusting gas flows to 30 L/min with 100% relative humidity, heated to 37 C, adjusting FiO2 levels to maintain SpO2 between 92 and 96%. After 20 min, each patient remaining on ventilatory support with HFNC will receive administration of salbutamol 2.5 mg via the vibrating mesh nebulizer (VMN) (Aerogen Solo®, Aerogen Ltd., Galway, Ireland) positioned immediately downstream of the humidification chamber of the HFNC system, using the dedicated connector.

Group Type EXPERIMENTAL

salbutamol 2.5 mg via vibrating mesh nebulizer (VMN)

Intervention Type 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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No