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

NCT06457399 | Active Not Recruiting

• 1 other identifier: HELIOX ON AIRWAY STENOSIS
• Study Type: observational
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Airway Obstruction

Keywords

Heliox; Airway Stenosis; Work of breathing; Airway resistance

Outcome Measures

Primary Outcomes (1)

• Changes in Neural Ventilatory Drive (%):

  Percentage over the Root Mean Square peak for parasternal electromyography (EMG): averaged of the square root of the peak value and the area under the curve of parasternal EMG (%RootMeanSquare) adjusted for respiratory frequency, as a surrogate of diaphragmatic EMG, and sternocleidomastoid EMG, which will give us information on accessory muscle activation.

  30 minutes with Heliox and 30 minutes with Oxygen 31%

Secondary Outcomes (9)

• Diaphragmatic excursion assessed with ultrasound

  At minute 15 during the Heliox test and at minute 15 during the Oxygen 31% test.

• Thickening fraction of the diaphragm assessed by ultrasound

  At minute 15 during the Heliox test and at minute 15 during the Oxygen 31% test.

• Changes in thoracoabdominal synchrony

  Phase angle was calculated from 10 consecutive breaths at minutes 1, 5, 15 and 30 during the Heliox test and the Oxygen 31% test.

• Borg Scale Dyspnea evolution (points)

  Basal value and at minutes 1, 5, 15 and 30 during the Heliox test and the Oxygen 31% test.

• Oxygen saturation

  Basal value and at minutes 1, 5, 15 and 30 during the Heliox test and the Oxygen 31% test.

Study Arms (1)

Airway Stenosis

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

Drug: Heliox; Drug: Oxygen

Interventions

Heliox 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.

Also known as: Helium - Oxygen

Airway Stenosis

Oxygen DRUG

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

Also known as: Oxygen 31%

Airway Stenosis

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients will be recluted from the pneumology outpatient clinic of the Hospital 12 de Octubre

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Universitario 12 de Octubre: lead

Study Sites (1)

Marta Corral Blanco

Madrid, 28041, Spain

Location

MeSH Terms

Conditions

Airway Obstruction

Interventions

heliox; Oxygen

Condition Hierarchy (Ancestors)

Respiratory Insufficiency; Respiration Disorders; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Chalcogens; Elements; Inorganic Chemicals; Gases

Study Officials

• Marta Corral Blanco, MD

  Hospital 12 de Octubre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 30, 2024
• First Posted: June 13, 2024
• Study Start: April 27, 2022
• Primary Completion: May 31, 2023
• Study Completion: November 1, 2024
• Last Updated: June 13, 2024

Record last verified: 2024-06

Locations

ES (1)