Advanced Respiratory Monitoring and Oxygen Therapy in Chronically Ill Patients With Acute Respiratory Failure

NCT ID: NCT07157696

Last Updated: 2025-10-03

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-03
• Study Completion Date: 2027-01-30

Brief Summary

This study is testing whether a new type of home oxygen therapy, called high-flow nasal cannula (HFNC), can improve breathing comfort and quality of life for people with long-term lung or heart conditions who need oxygen after leaving the hospital.

HFNC delivers warm, humidified oxygen at higher flow rates than standard oxygen therapy, which may reduce shortness of breath, improve sleep, and make daily activities easier. The therapy will be provided using the myAirvo™3 device, which also allows doctors to check patients' oxygen levels, heart rate, and symptoms remotely. All patients will also wear a small device (RootiREX) to monitor heart rhythm, sleep quality, and detect breathing pauses at night.

Participants will try both treatments - HFNC and standard oxygen therapy - for short periods, in random order, so that researchers can directly compare the effects within the same patient. Each treatment period will last two weeks, with a short break in between.

The main goal of the study is to see whether HFNC reduces shortness of breath (measured by the modified Medical Research Council scale). Other outcomes include comfort, sleep quality, quality of life, oxygen levels, and how well patients are able to use the devices at home.

The study will last six weeks in total for each participant. Researchers expect that HFNC will improve breathing comfort, stabilize oxygen levels, and reduce the need for hospital visits during this time.

Conditions

Chronic Respiratory Failure; Cardiac Disease, Pulmonary Disease; Acute Respiratory Failure (ARF)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

High flow nasal cannulae treatment

Participants assigned to this arm will receive home-based high-flow nasal cannula (HFNC) oxygen therapy using the myAirvo™3 device. The device delivers warm, humidified air with supplemental oxygen at a flow rate of ≥30 liters per minute, set at 37°C. Oxygen will be adjusted to maintain blood oxygen saturation (SpO₂) at or above 92%.

• Group HFNC will receive HFNC during weeks 1-2, followed by a 2-day washout period, then low-flow oxygen during weeks 3-4, followed by a second 2-day washout period, and will resume HFNC during weeks 5-6

Group Type: EXPERIMENTAL

High-Flow Nasal Cannula (HFNC) Oxygen Therapy

Intervention Type: DEVICE

Type: Device / Procedure

Description: Humidified high-flow nasal cannula oxygen therapy delivered via a home device. Provides warmed (37°C), humidified air and supplemental oxygen at ≥30 L/min, titrated to maintain oxygen saturation (SpO₂) ≥92%. Patients are instructed to use the device for ≥8 hours per day, preferably overnight.

Special Features: Integrated remote monitoring system that automatically records flow, FiO₂, SpO₂, heart rate, and usage time, transmitting data to a secure cloud platform for clinical follow-up.

Oxygen therapy

Intervention Type: DEVICE

Type: Device / Procedure

Description: Standard long-term oxygen therapy delivered through conventional low-flow systems (e.g., nasal cannula or mask). Oxygen is titrated to maintain oxygen saturation (SpO₂) ≥92%. Patients are instructed to use oxygen for ≥8 hours per day, preferably overnight.

Special Features: No humidification, high-flow delivery, or remote monitoring capabilities.

Oxygen low therapy

Participants assigned to this arm will receive standard long-term oxygen therapy delivered by a conventional low-flow oxygen device. Oxygen will be titrated to maintain blood oxygen saturation (SpO₂) at or above 92%. • Group low flow oxygen will receive low-flow oxygen during weeks 1-2, followed by a 2-day washout period, then HFNC during weeks 3-4, followed by a second 2-day washout period, and will resume low-flow oxygen during weeks 5-6.

Group Type: ACTIVE_COMPARATOR

High-Flow Nasal Cannula (HFNC) Oxygen Therapy

Intervention Type: DEVICE

Type: Device / Procedure

Description: Humidified high-flow nasal cannula oxygen therapy delivered via a home device. Provides warmed (37°C), humidified air and supplemental oxygen at ≥30 L/min, titrated to maintain oxygen saturation (SpO₂) ≥92%. Patients are instructed to use the device for ≥8 hours per day, preferably overnight.

Special Features: Integrated remote monitoring system that automatically records flow, FiO₂, SpO₂, heart rate, and usage time, transmitting data to a secure cloud platform for clinical follow-up.

Oxygen therapy

Intervention Type: DEVICE

Type: Device / Procedure

Description: Standard long-term oxygen therapy delivered through conventional low-flow systems (e.g., nasal cannula or mask). Oxygen is titrated to maintain oxygen saturation (SpO₂) ≥92%. Patients are instructed to use oxygen for ≥8 hours per day, preferably overnight.

Special Features: No humidification, high-flow delivery, or remote monitoring capabilities.

Interventions

High-Flow Nasal Cannula (HFNC) Oxygen Therapy

Type: Device / Procedure

Description: Humidified high-flow nasal cannula oxygen therapy delivered via a home device. Provides warmed (37°C), humidified air and supplemental oxygen at ≥30 L/min, titrated to maintain oxygen saturation (SpO₂) ≥92%. Patients are instructed to use the device for ≥8 hours per day, preferably overnight.

Special Features: Integrated remote monitoring system that automatically records flow, FiO₂, SpO₂, heart rate, and usage time, transmitting data to a secure cloud platform for clinical follow-up.

Intervention Type: DEVICE

Oxygen therapy

Type: Device / Procedure

Description: Standard long-term oxygen therapy delivered through conventional low-flow systems (e.g., nasal cannula or mask). Oxygen is titrated to maintain oxygen saturation (SpO₂) ≥92%. Patients are instructed to use oxygen for ≥8 hours per day, preferably overnight.

Special Features: No humidification, high-flow delivery, or remote monitoring capabilities.

Intervention Type: DEVICE

Eligibility Criteria

Exclusion Criteria

Life expectancy < 3 months Inability to comply with home follow-up procedures.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Arcispedale S. Anna, Ferrara

UNKNOWN

Sponsor Role: collaborator

University Hospital of Ferrara

OTHER

Sponsor Role: collaborator

Università degli Studi di Ferrara

OTHER

Sponsor Role: lead

Responsible Party

Savino Spadaro

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Savino Spadaro, Associate professor

Role: CONTACT

spdsvn@unife.it

+393894841243

References

Nagata K, Kikuchi T, Horie T, Shiraki A, Kitajima T, Kadowaki T, Tokioka F, Chohnabayashi N, Watanabe A, Sato S, Tomii K. Domiciliary High-Flow Nasal Cannula Oxygen Therapy for Patients with Stable Hypercapnic Chronic Obstructive Pulmonary Disease. A Multicenter Randomized Crossover Trial. Ann Am Thorac Soc. 2018 Apr;15(4):432-439. doi: 10.1513/AnnalsATS.201706-425OC.

Reference Type: RESULT

PMID: 29283682 (View on PubMed)

Weinreich UM, Burchardt C, Huremovic J. The effect of domiciliary high flow nasal cannula treatment on dyspnea and walking distance in patients with interstitial lung disease - A pilot study. Chron Respir Dis. 2022 Jan-Dec;19:14799731221137085. doi: 10.1177/14799731221137085.

Reference Type: RESULT

PMID: 36366859 (View on PubMed)

Other Identifiers

HOME- Oxygen Trial

Identifier Type: -

Identifier Source: org_study_id