RecruitingNCT06563167

Detection and Prediction of Clinically Significant Pneumothorax After Image-guided Transthoracic Lung Biopsy

Prospective Study on Detection and Prediction of Clinically Significant Pneumothorax After Image-guided Transthoracic Lung Biopsy


Sponsor

Chinese University of Hong Kong

Enrollment

330 participants

Start Date

Sep 1, 2024

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria2

  • 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 Criteria4

  • 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

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Interventions

DIAGNOSTIC_TESTCXR

CXRs will be performed at 3 different time points - (i) within 1 hour after TTLB, (ii) at 4 hours (± 1 hour) after TTLB and (iii) at 18 hours (± 2 hours) after TTLB.


Locations(1)

Chinese University of Hong Kong

Hong Kong, Hong Kong

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NCT06563167


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