Clinical trial NCT06457399: Heliox on the Work of Breathing in Adult Patients With Lower Airway Stenosis
Official title: The Effect of Heliox on the Work of Breathing in Adult Patients With Lower Airway Stenosis
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Airway Obstruction
Keywords: Heliox
Airway Stenosis
Work of breathing
Airway resistance
Lead sponsor: Hospital Universitario 12 de Octubre
Sponsor class: OTHER
First posted: 2024-06-13
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients will be recluted from the pneumology outpatient clinic of the Hospital 12 de Octubre

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Changes in Neural Ventilatory Drive (%):
timeFrame: 30 minutes with Heliox and 30 minutes with Oxygen 31%
Secondary outcomes:
measure: Diaphragmatic excursion assessed with ultrasound
timeFrame: At minute 15 during the Heliox test and at minute 15 during the Oxygen 31% test.
measure: Thickening fraction of the diaphragm assessed by ultrasound
timeFrame: At minute 15 during the Heliox test and at minute 15 during the Oxygen 31% test.
measure: Changes in thoracoabdominal synchrony
timeFrame: Phase angle was calculated from 10 consecutive breaths at minutes 1, 5, 15 and 30 during the Heliox test and the Oxygen 31% test.
measure: Borg Scale Dyspnea evolution (points)
timeFrame: Basal value and at minutes 1, 5, 15 and 30 during the Heliox test and the Oxygen 31% test.
measure: Oxygen saturation
timeFrame: Basal value and at minutes 1, 5, 15 and 30 during the Heliox test and the Oxygen 31% test.
measure: Transcutaneous partial pressure of carbon dioxide
timeFrame: Basal value and at minutes 1, 5, 15 and 30 during the Heliox test and the Oxygen 31% test.
measure: Blood pressure
timeFrame: Basal value and at minutes 1, 5, 15 and 30 during the Heliox test and the Oxygen 31% test.
measure: Heart rate
timeFrame: Basal value and at minutes 1, 5, 15 and 30 during the Heliox test and the Oxygen 31% test.
measure: Respiratory rate
timeFrame: Basal value and at minutes 1, 5, 15 and 30 during the Heliox test and the Oxygen 31% test.
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Marta Corral Blanco
Study officials:
affiliation: Hospital 12 de Octubre
name: Marta Corral Blanco, MD
role: PRINCIPAL_INVESTIGATOR
References: