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NCT Number: NCT07508943

Decision-making and Optimization of Ventilatory Support for AECOPD Patients

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.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Sir Run Run Shaw Hospital Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310016, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Huiqing Ge, PhD

CONTACT

[email protected]

+86 13588706787

Mengyun Zhou, MS

CONTACT

[email protected]

+86 13391882759

Sponsors and collaborators

Lead sponsor

Sir Run Run Shaw Hospital

Other

Registry information

Acronym: OPTIVENT-COPD

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Apr 2, 2026
Registry last updated
Apr 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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