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NCT06563167
Detection and Prediction of Clinically Significant Pneumothorax After Image-guided Transthoracic Lung Biopsy
Conditions: Lung Biopsy
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 330
Sponsor: Chinese University of Hong Kong
Location: Chinese University of Hong Kong Hong Kong
Summary
Objective: The goal of this study is to evaluate the sensitivity and specificity of the presence of pneumothorax on a 4-hour CXR after image-guided transthoracic lung biopsy (TTLB) for diagnosing subsequent clinically significant pneumothorax.
Hypothesis to be tested: The investigators hypothesize that an absence of pneumothorax on CXR at 4 hours can accurately predict an absence of clinically significant pneumothorax at 16 to 20 hours.
Design and subjects: This is a prospective, single-centre, diagnostic accuracy study conducted at a tertiary referral centre in Hong Kong. Patients will be recruited if an image-guided TTLB is arranged.
Study instruments: CXRs will be performed for patients at different time points. The presence and size of pneumothorax (if any) will be recorded.
Outcome: The diagnostic capacity of a 4-hour CXR after image-guided TTLB will be provide evidence regarding the safety and patient selection for same-day discharge.
Eligibility Criteria
Inclusion Criteria:
* Patients whose image-guided TTLB, including ultrasound or CT-guided, is arranged for diagnostic purposes
* Patients who are able to sign written informed consent to participate in the study
Exclusion Criteria:
* Patients with resolution of lung lesion prior to the scheduled image-guided TTLB
* Patients have active exacerbation of underlying diseases causing unstable respiratory conditions (e.g. exacerbation of COPD, pneumonia) which would lower the threshold for invasive interventions for iatrogenic pneumothorax
* Patients with psychiatric disease or cognitive impairment that may limit their ability to understand or give consent to the study
* Patients who decline to join the study
Source: ClinicalTrials.gov (NCT06563167). StuddyBuddy aggregates publicly available trial information.