Remote Intervention Versus Routine Monitoring in COPD Patients With Chronic Hypercapnia Receiving Home Non-invasive Respiratory Support

NCT07751003 | Not Yet Recruiting

• 1 other identifier: 20260597
• Study Type: interventional
• Target: 236
• Locations: 1 country
• Sites: 4

Brief Summary

This study is a randomized controlled trial designed to compare the effectiveness of active remote intervention versus passive monitoring alone in patients with Chronic Obstructive Pulmonary Disease (COPD) and chronic hypercapnic respiratory failure who are receiving home non-invasive respiratory support. The primary goal is to evaluate the impact on health-related quality of life and the frequency of acute exacerbations over a 12-month period.

Conditions

Acute Exacerbation of COPD; Hypercapnia; COPD (Chronic Obstructive Pulmonary Disease)

Keywords

Home management; Telehealth

Outcome Measures

Primary Outcomes (2)

• Change in Health-Related Quality of Life

  Measured by the change from baseline in the total score of the St. George's Respiratory Questionnaire (SGRQ) questionnaire at 12 months.

  Baseline to 12 months

• Number of COPD Exacerbations

  The number of acute exacerbations requiring antibiotics and/or systemic corticosteroids within 12 months.

  12 months

Secondary Outcomes (8)

• Change in PaCO₂

  Baseline, 1, 3, 6, 12 months

• Changes in PaO₂

  Baseline, 1, 3, 6, 12 months

• Change in Dyspnea Severity (mMRC Score)

  Baseline, 1, 3, 6, 12 months

• Change in CAT Score

  Baseline, 1, 3, 6, and 12 months

• Change in SRI Score

  Time Frame: Baseline, 1, 3, 6, and 12 months

Study Arms (2)

Remote Intervention Group

EXPERIMENTAL

Participants will receive home non-invasive respiratory support combined with active remote management.

Other: Remote Management; Other: Remote Monitoring Only

Monitoring Control Group

ACTIVE COMPARATOR

Participants will receive home non-invasive respiratory support with remote monitoring only.

Other: Remote Monitoring Only

Interventions

Remote Management OTHER

Participants will receive home non-invasive respiratory support combined with active remote management. This includes regular analysis of ventilation data, assessment of oxygenation status, risk prediction, and remote parameter adjustment by a respiratory therapist.

Remote Intervention Group

Remote Monitoring Only OTHER

Participants will receive home non-invasive respiratory support with remote monitoring only. No active intervention will be performed by the study team based on the data. Patients will continue with standard care from their primary physician.

Monitoring Control Group; Remote Intervention Group

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Meets the diagnostic criteria for Chronic Obstructive Pulmonary Disease (COPD) with confirmed persistent airflow limitation by spirometry.
• Hospitalized due to an acute exacerbation of COPD.
• Stable daytime arterial blood gas analysis showing PaCO₂ ≥ 50 mmHg, with hypoxemia.
• Already receiving or planned to receive long-term home non-invasive respiratory support.
• Capable of using a smartphone or tablet for video communication and has internet access.
• Willing to participate and provides written informed consent.

You may not qualify if:

• Concurrent severe pulmonary diseases (e.g., active tuberculosis, diffuse pulmonary fibrosis, advanced lung cancer).
• Chronic respiratory failure primarily caused by non-COPD conditions (e.g., neuromuscular disease, chest wall deformity, or severe obesity hypoventilation syndrome).
• Severe cognitive impairment or psychiatric illness that would prevent cooperation with remote management.
• Other severe systemic diseases with an expected survival of less than 1 year (e.g., advanced malignancy).
• Pregnant or lactating women.

Sponsors & Collaborators

• Sir Run Run Shaw Hospital: lead

Study Sites (4)

Henan Provincial People's Hospital

Zhengzhou, Henan, China

Location

The Second Xiangya Hospital of Central South University

Changsha, Hunan, 410006, China

Location

Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, 310016, China

Location

Taizhou Hospital of Integrated Traditional Chinese and Western Medicine

Wenling, Zhejiang, 317523, China

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Hypercapnia

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Respiratory; Signs and Symptoms

Central Study Contacts

Huiqing Ge, MD, PhD

CONTACT

+86 13588706787; gehq@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Respiratory Care Department

Study Record Dates

• First Submitted: July 30, 2026
• First Posted: August 6, 2026
• Study Start (Estimated): August 1, 2027
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: August 6, 2026

Record last verified: 2026-07

Locations

CN (4)