Decision-making and Optimization of Ventilatory Support for AECOPD Patients (OPTIVENT-COPD)

March 27, 2026 updated by: Huiqing Ge, Sir Run Run Shaw Hospital

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. How are different respiratory support modalities selected for patients with AECOPD in real-world practice?
  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.

Participants will not receive any study-assigned intervention. The study will use existing clinical data collected during routine inpatient care and will not change diagnosis, treatment, or follow-up.

Study Overview

Status

Not yet recruiting

Conditions

Detailed Description

Acute exacerbation of chronic obstructive pulmonary disease (AECOPD) is a major cause of hospitalization, respiratory failure, and poor clinical outcomes in patients with chronic obstructive pulmonary disease. Respiratory support is a key component of acute management and commonly includes conventional oxygen therapy (COT), high-flow nasal cannula oxygen therapy (HFNC), non-invasive ventilation (NIV), and invasive mechanical ventilation (IMV). In clinical practice, respiratory support decisions are not static; rather, they involve a dynamic and sequential process of initial selection, reassessment, escalation, de-escalation, switching, and withdrawal according to changes in patient condition. Inappropriate timing of escalation or unnecessary use of higher-intensity support may contribute to treatment failure and unfavorable outcomes.

This study is a retrospective observational study based on routinely collected clinical data from hospitalized patients with AECOPD. Using historical data extracted from hospital clinical information systems and electronic medical records, the study will systematically characterize respiratory support pathways during hospitalization and examine how support strategies are adjusted over time in response to changes in disease status. The study will not introduce any additional tests, procedures, or interventions, and will not alter prior or current clinical care.

The analytical framework of the study is based on sequential decision analysis. Patient condition will be reassessed at fixed time intervals during hospitalization using key physiological and monitoring parameters recorded in routine care. These indicators will be integrated into clinically interpretable disease-state strata, and each state will be linked to the respiratory support modality being used at that stage. The respiratory support decision at the subsequent stage will then be characterized as maintenance, escalation, de-escalation, switching, or discontinuation. Under clinically reasonable safety and feasibility constraints, retrospective data will be used to summarize the statistical patterns of disease evolution and outcomes associated with different respiratory support choices. Dynamic programming methods will be applied to explore interpretable sequential decision patterns aligned with relevant clinical goals, such as reducing treatment failure and intubation-related adverse outcomes, while avoiding unnecessary use of high-intensity support and excessive switching between modalities.

Data used in this study will be derived entirely from existing inpatient records and will include demographic and baseline information, disease- and hospitalization-related information, key physiological and monitoring indicators, respiratory support records, and outcome-related information such as treatment escalation, intubation, and in-hospital outcomes. All data will be retrospectively extracted and de-identified before analysis. Only authorized research personnel will have access to the study database. Study findings will be reported in aggregate form, and no personally identifiable information will be disclosed.

Because this study uses previously collected clinical data only, does not involve direct participant contact, and does not affect clinical management, a waiver of informed consent will be sought in accordance with institutional ethics requirements.

Study Type

Observational

Enrollment (Estimated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Huiqing Ge, PhD
  • Phone Number: +86 13588706787
  • Email: gehq@zju.edu.cn

Study Contact Backup

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310016
        • Sir Run Run Shaw Hospital Zhejiang University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

• 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mortality
Time Frame: From study inclusion unitl death or up to 28 days of follow-up, whichever occurs first
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
ICU Length of stay
Time Frame: From ICU admission until ICU discharge (transfer to a general ward or hospital discharge), assessed up to 90 days
the total time when a patient is admitted to the ICU until they are discharged
From ICU admission until ICU discharge (transfer to a general ward or hospital discharge), assessed up to 90 days
Duration of (Invasive) Mechanical Ventilation
Time Frame: From initiation of invasive mechanical ventilation until discontinuation of ventilatory support (weaning completion), assesed up to 28 days
starts when a patient is connected to a ventilator and ends when ventilator is weaning
From initiation of invasive mechanical ventilation until discontinuation of ventilatory support (weaning completion), assesed up to 28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sir Run Run Shaw Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 18, 2026

Primary Completion (Estimated)

March 18, 2029

Study Completion (Estimated)

March 18, 2029

Study Registration Dates

First Submitted

March 20, 2026

First Submitted That Met QC Criteria

March 27, 2026

First Posted (Actual)

April 2, 2026

Study Record Updates

Last Update Posted (Actual)

April 2, 2026

Last Update Submitted That Met QC Criteria

March 27, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2026-0254

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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