Heliox on the Work of Breathing in Adult Patients With Lower Airway Stenosis

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

ACTIVE_NOT_RECRUITING

Total Enrollment

18 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-04-27

Study Completion Date

2024-11-30

Brief Summary

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

Heliox (a mixture of Helium and Oxygen) can reduce the work of breathing in patients with airway stenosis by modifying turbulent flow into laminar flow. The aim of this study was to analyze the effect of Heliox versus conventional oxygen therapy in patients with lower airway stenosis on muscular effort measured by electromyography and diaphragmatic ultrasound, thoracoabdominal synchrony assessed with plethysmographic bands, dyspnea, stridor, oxygen saturation, transcutaneous carbon dioxide value, blood pressure, heart rate and respiratory rate.

Related Clinical Trials

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

Helium-oxygen Gas Mixtures Delivered by a High Flow Nasal Cannula in Bronchiolitis

NCT02373683

Bronchiolitis Heliox Pediatrics

TERMINATED NA

Effects of Non-invasive Ventilation With Helium-oxygen Mixture in Premature Infants With Respiratory Distress Syndrome

NCT04404816

Respiratory Distress Syndrome Premature Infants

COMPLETED PHASE1/PHASE2

Helium Oxygen Mixture in the Treatment of Meconium Aspiration Syndrome

NCT02620891

Neonatal Meconium Aspiration

COMPLETED NA

Effect of Heliox on RSV Bronchiolitis

NCT03171142

RSV Infection Acute Bronchiolitis

COMPLETED PHASE3

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

Detailed Description

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

Lower airway stenosis results in increased work of breathing with stridor and dyspnea, as a consequence of the increased resistances caused by the reduction in airway diameter. Airway resistance also depends on the length of the airway and the type of gas flow. Heliox (a mixture of Helium and Oxygen) is a gas less dense than air, which can change the flow from turbulent to laminar, reducing airway resistance by 20 to 40%, and therefore decreasing the work of breathing. Heliox is an inert gas that does not react with biological membranes, so there are few complications associated with its use, the most relevant being hypoxemia when fixed mixtures are not used and the the fraction of inspired oxygen (FiO2) supplied is less than 21%. The aim of the study was to evaluate if during the perioperative period of lower airway stenosis the administration of Heliox compared to oxygen could reduce the work of breathing and improve dyspnea. For this purpose, patients were treated for 30 minutes with Heliox (fixed mixture of 70% helium and 30% oxygen) using a non rebreather mask or reservoir bag versus 30 minutes with oxygen 31% using a Venturi mask.

Conditions

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

Airway Obstruction

Study Design

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

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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

Airway Stenosis

Patients with lower airway stenosis on waiting list for endoscopic intervention on stenosis by respiratory endoscopy unit.

Heliox

Intervention Type DRUG

Treatment for 30 minutes with Heliox from a commercial tank (Oxhelⓒ, Air Liquideⓒ) with a fixed mixture of 70% helium and 30% oxygen with non-rebreather mask or reservoir bag at a flow of 12-15 lpm.

Oxygen

Intervention Type DRUG

Treatment for 30 minutes with oxygen at FiO2 of 31% with Venturi mask.

Interventions

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

Heliox

Treatment for 30 minutes with Heliox from a commercial tank (Oxhelⓒ, Air Liquideⓒ) with a fixed mixture of 70% helium and 30% oxygen with non-rebreather mask or reservoir bag at a flow of 12-15 lpm.

Intervention Type DRUG

Oxygen

Treatment for 30 minutes with oxygen at FiO2 of 31% with Venturi mask.

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Helium - Oxygen Oxygen 31%

Eligibility Criteria

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

Inclusion Criteria

* Patients with lower airway stenosis evaluated at the Respiratory Endoscopy Unit of the Hospital Universitario 12 de Octubre on the waiting list for endoscopic intervention on stenosis.
* Stenosis grade ≥ 3 and Borg scale score \> 2.

Exclusion Criteria

* Presence of relevant comorbidities (uncontrolled ischemic heart disease, ventricular dysfunction, pneumopathies with severe respiratory insufficiency, severe pulmonary hypertension).
* Inability to perform the test due to severe dyspnea or need for emergency intervention.
* Patient on continuous mechanical ventilation, invasive or non-invasive.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No