Decision-making and Optimization of Ventilatory Support for AECOPD Patients

NCT07508943 | Not Yet Recruiting DMC

• 1 other identifier: 2026-0254
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this retrospective observational study is to learn about how respiratory support is selected and adjusted in hospitalized patients with acute exacerbation of chronic obstructive pulmonary disease (AECOPD). The main questions it aims to answer are:

1. 1.How are different respiratory support modalities selected for patients with AECOPD in real-world practice?
2. 2.What clinical patterns are associated with escalation, de-escalation, switching, or discontinuation of respiratory support during hospitalization? Researchers will review de-identified hospital records of patients admitted with AECOPD and analyze the dynamic use of respiratory support during hospitalization, including conventional oxygen therapy, high-flow nasal cannula oxygen therapy, non-invasive ventilation, and invasive mechanical ventilation.

Conditions

Acute Exacerbation of Chronic Obstructive Pulmonary Disease

Keywords

Acute Exacerbation of Chronic Obstructive Pulmonary Disease; Decision-Making; Real-World Data; Dynamic Programming; Respiratory Support

Outcome Measures

Primary Outcomes (1)

• Mortality

  the number of deaths in the hospitalized AECOPD patients

  From study inclusion unitl death or up to 28 days of follow-up, whichever occurs first

Secondary Outcomes (2)

• ICU Length of stay

  From ICU admission until ICU discharge (transfer to a general ward or hospital discharge), assessed up to 90 days

• Duration of (Invasive) Mechanical Ventilation

  From initiation of invasive mechanical ventilation until discontinuation of ventilatory support (weaning completion), assesed up to 28 days

Study Arms (1)

AECOPD group

Hospitalized patients with acute exacerbation of chronic obstructive pulmonary disease (AECOPD) identified from historical hospital records who received routine clinical evaluation and management . The cohort includes patients who received one or more respiratory support modalities as part of usual care, including conventional oxygen therapy, high-flow nasal cannula oxygen therapy, noninvasive ventilation, and invasive mechanical ventilation. This is an observational study, and no intervention is assigned by the protocol.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will be selected retrospectively from hospitalized patients with acute exacerbation of chronic obstructive pulmonary disease . The source population includes patients receiving routine inpatient care, with particular relevance to critically ill patients with high-quality intensive care data. Eligible participants will be identified from hospital clinical information systems and electronic medical records based on diagnosis, respiratory support records, and availability of dynamic clinical data collected during hospitalization.

You may qualify if:

• Hospitalized patients with a documented diagnosis of acute exacerbation of chronic obstructive pulmonary disease.
• Patients identified retrospectively from hospital records during the predefined study period.
• Patients who received at least one form of respiratory support during the index hospitalization, including conventional oxygen therapy, high-flow nasal cannula oxygen therapy, noninvasive ventilation, or invasive mechanical ventilation.
• Patients with available clinical records containing sufficient dynamic physiological, laboratory, and treatment-related data for retrospective analysis.

You may not qualify if:

• Patients whose hospitalization was not primarily due to acute exacerbation of COPD, even if COPD was documented as a comorbidity.
• Patients with stable COPD and no evidence of acute exacerbation during the index hospitalization.
• Patients admitted primarily for other acute conditions, including but not limited to pneumonia without documented AECOPD, acute heart failure, pulmonary embolism, pneumothorax, asthma exacerbation, trauma, or postoperative care.
• Patients with insufficient documentation to confirm AECOPD as the primary reason for admission.
• Patients with incomplete clinical records preventing retrospective analysis.
• Repeated hospitalizations of the same patient during the study period, with only the first eligible admission included.

Sponsors & Collaborators

• Sir Run Run Shaw Hospital: lead

Study Sites (1)

Sir Run Run Shaw Hospital Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310016, China

Location

Related Publications (8)

• Davidson C, Banham S, Elliott M, Kennedy D, Gelder C, Glossop A, Church C, Creagh-Brown B, Dodd J, Felton T, Foex B, Mansfield L, McDonnell L, Parker R, Patterson C, Sovani M, Thomas L. British Thoracic Society/Intensive Care Society Guideline for the ventilatory management of acute hypercapnic respiratory failure in adults. BMJ Open Respir Res. 2016 Mar 14;3(1):e000133. doi: 10.1136/bmjresp-2016-000133. eCollection 2016. No abstract available.

  PMID: 27026806 BACKGROUND

• Tan D, Wang B, Cao P, Wang Y, Sun J, Geng P, Walline JH, Wang Y, Wang C. High flow nasal cannula oxygen therapy versus non-invasive ventilation for acute exacerbations of chronic obstructive pulmonary disease with acute-moderate hypercapnic respiratory failure: a randomized controlled non-inferiority trial. Crit Care. 2024 Jul 18;28(1):250. doi: 10.1186/s13054-024-05040-9.

  PMID: 39026242 BACKGROUND

• Rochwerg B, Brochard L, Elliott MW, Hess D, Hill NS, Nava S, Navalesi P Members Of The Steering Committee, Antonelli M, Brozek J, Conti G, Ferrer M, Guntupalli K, Jaber S, Keenan S, Mancebo J, Mehta S, Raoof S Members Of The Task Force. Official ERS/ATS clinical practice guidelines: noninvasive ventilation for acute respiratory failure. Eur Respir J. 2017 Aug 31;50(2):1602426. doi: 10.1183/13993003.02426-2016. Print 2017 Aug.

  PMID: 28860265 BACKGROUND

• Tan D, Walline JH, Ling B, Xu Y, Sun J, Wang B, Shan X, Wang Y, Cao P, Zhu Q, Geng P, Xu J. High-flow nasal cannula oxygen therapy versus non-invasive ventilation for chronic obstructive pulmonary disease patients after extubation: a multicenter, randomized controlled trial. Crit Care. 2020 Aug 6;24(1):489. doi: 10.1186/s13054-020-03214-9.

  PMID: 32762701 BACKGROUND

• Li M, Wang F, Chen R, Liang Z, Zhou Y, Yang Y, Chen S, Ung COL, Hu H. Factors contributing to hospitalization costs for patients with COPD in China: a retrospective analysis of medical record data. Int J Chron Obstruct Pulmon Dis. 2018 Oct 12;13:3349-3357. doi: 10.2147/COPD.S175143. eCollection 2018.

  PMID: 30349238 BACKGROUND

• Lin P, Shen C, Li Q, Huang Y, Zhou J, Lu Y, He A, Liu X, Luo M. A systematic review and meta-analysis of chronic obstructive pulmonary disease in asia: risk factors for readmission and readmission rate. BMC Pulm Med. 2024 Aug 12;24(1):388. doi: 10.1186/s12890-024-03203-6.

  PMID: 39129020 BACKGROUND

• Hoogendoorn M, Hoogenveen RT, Rutten-van Molken MP, Vestbo J, Feenstra TL. Case fatality of COPD exacerbations: a meta-analysis and statistical modelling approach. Eur Respir J. 2011 Mar;37(3):508-15. doi: 10.1183/09031936.00043710. Epub 2010 Jul 1.

  PMID: 20595157 BACKGROUND

• Wang Z, Lin J, Liang L, Huang F, Yao X, Peng K, Gao Y, Zheng J. Global, regional, and national burden of chronic obstructive pulmonary disease and its attributable risk factors from 1990 to 2021: an analysis for the Global Burden of Disease Study 2021. Respir Res. 2025 Jan 2;26(1):2. doi: 10.1186/s12931-024-03051-2.

  PMID: 39748260 BACKGROUND

Central Study Contacts

Huiqing Ge, PhD

CONTACT

+86 13588706787; gehq@zju.edu.cn

Mengyun Zhou, MS

CONTACT

+86 13391882759; 3325184@zju.edu.cn

Study Design

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

Study Record Dates

• First Submitted: March 20, 2026
• First Posted: April 2, 2026
• Study Start: March 18, 2026
• Primary Completion (Estimated): March 18, 2029
• Study Completion (Estimated): March 18, 2029
• Last Updated: April 2, 2026

Record last verified: 2026-03

Locations

CN (1)