Effect of HIgh-flow Therapy in Long-term Oxygen Therapy (HILOT)

Skane University Hospital

Status: Enrolling

Conditions: Chronic Respiratory Failure With Hypoxia; Chronic Obstructive Pulmonary Disease Severe; Interstitial Lung Disease

Treatments: Device: Added high-flow oxygen therapy; Other: Standard care

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06247397

HILOT

Details and patient eligibility

About

This is a registry-based, randomized, controlled clinical trial of the effect of added high-flow oxygen therapy (using the device Lumis HFT) during one year in people with long-term oxygen therapy (LTOT) for chronic obstructive pulmonary disease (COPD) or interstitial lung disease (ILD).

Full description

This is a registry-based, randomized, controlled clinical trial of patients with LTOT for COPD or ILD recruited using the Swedish National Registry for Respiratory Failure (Swedevox) in collaboration with a research network within the Swedish Respiratory Society. The trial evaluates the effect of added high-flow oxygen therapy nighttime to the regular low-flow oxygen therapy compared with regular low-flow oxygen therapy alone up to one year.

The purpose of this project is to improve evidence-based treatment of people with chronic respiratory failure, currently about 2000 patients annually in Sweden, who have high risk of adverse events and mortality.

Enrollment: 310 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age 40 years or older
• Ongoing LTOT: prescribed for at least 15 hours per day; and since at least 28 days as registered in Swedevox
• COPD or ILD as main underlying reason for LTOT
• Oxygen concentrator as stationary oxygen source in the home including night-time
• Body mass index (BMI) < 35 kg/m2

Exclusion criteria

• Current or previous treatment with home HFOT
• Current treatment with home mechanical ventilation
• Current treatment with home CPAP
• Hospitalized during the last 2 weeks
• Current smoking or contact with flames
• Self-reported average use of the LTOT < 15h per day (24 hours)
• PaCO2 (breathing air at rest) > 8 kPa
• Strong clinical suspicion of obstructive sleep apnea (OSA) or obesity-related hypoventilation syndrome (OHS) (as judged by the responsible staff)
• Inability to participate in the study procedures (as judged by the staff)
• Not eligible for continuing LTOT due to other reason (as judged by the staff)
• Expected survival less than 3 months (as judged by the staff)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

310 participants in 2 patient groups

High-flow oxygen therapy

Experimental group

Description:

Intervention arm

Treatment:

Device: Added high-flow oxygen therapy

Low-flow oxygen therapy

Active Comparator group

Description:

Comparison arm

Treatment:

Other: Standard care