Decision-making and Optimization of Ventilatory Support for AECOPD Patients
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorSir Run Run Shaw Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial 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.
Trial design
Design model
Cohort
Time perspective
Retrospective
Treatments tested in this trial
Not listed
Trial groups
1,000 Participants
are grouped into 1 trial groupGroup A: AECOPD group
Trial outcomes
Primary outcomes
1
Mortality
the number of deaths in the hospitalized AECOPD patients
Time frame
From study inclusion unitl death or up to 28 days of follow-up, whichever occurs firstSecondary outcomes
1
ICU Length of stay
the total time when a patient is admitted to the ICU until they are discharged
Time frame
From ICU admission until ICU discharge (transfer to a general ward or hospital discharge), assessed up to 90 days2
Duration of (Invasive) Mechanical Ventilation
starts when a patient is connected to a ventilator and ends when ventilator is weaning
Time frame
From initiation of invasive mechanical ventilation until discontinuation of ventilatory support (weaning completion), assesed up to 28 daysSponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: