Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06563167
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-17
Brief Title:
Detection and Prediction of Clinically Significant Pneumothorax After Image-guided Transthoracic Lung Biopsy
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Prospective Study on Detection and Prediction of Clinically Significant Pneumothorax After Image-guided Transthoracic Lung Biopsy
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Detailed Description:
Image-guided transthoracic lung biopsy TTLB by computed tomography CT or ultrasound guidance is an important diagnostic modality for various pulmonary diseases One of the most common and clinically important complications of TTLB is iatrogenic pneumothorax The estimated incidence of iatrogenic pneumothorax following TTLB ranges between 12 and 45 and 2 to 15 of these patients required chest drain insertion
The majority of post-TTLB iatrogenic pneumothorax occurs immediately after the procedure but delayed pneumothorax which happened hours after the biopsy is a recognized complication The incidence rate of delayed pneumothorax ranges between 04 and 86 and mostly could be detected at or within 4 hours after biopsy Among these delayed pneumothorax up to 60 were clinically significant and required chest drain insertion
There is no high-quality evidence informing physicians of the best timing of CXR in detecting delayed pneumothorax An ideal timing for this CXR should be late enough to capture the most delayed clinically significant pneumothorax yet promptly detect deterioration due to pneumothorax The British Thoracic Society guideline recommends an erect CXR 1 hour after the biopsy which is sufficient to detect the majority of post-biopsy pneumothorax The guideline also mentions that patients should be warned of delayed pneumothorax but does not mandate the need for subsequent CXR Overnight observation with a CXR the next day ie 16 to 20 hours after biopsy is a common local practice to detect the occurrence of delayed pneumothorax This practice although safe has not been examined extensively and involves a longer hospital stay for all patients receiving TTLB TTLB as a day procedure has been described instead A series of CXRs were used to ensure adequate detection of enlarging iatrogenic pneumothorax but it was labour-intensive
Our group conducted an internal audit covering 3 months of hospital data in Prince of Wales Hospital which includes 109 patients who underwent image-guided TTLB between Nov 2023 and Jan 2024 The incidences of pneumothorax and clinically significant pneumothorax requiring chest drain insertion were 23 211 and 7 64 respectively Among those patients who had chest drain insertion 4 had drains inserted within 3 hours after biopsy The remaining 3 patients had chest drains inserted at 16 to 19 hours after biopsy Their initial CXR at 1 hour showed no pneumothorax but did not receive interim CXR in between A separate group of 11 patients with CXR between 3 to 6 hours and no clinically significant pneumothorax were safely discharged the next day These preliminary data suggest that an interim CXR at 4 hours may allow timely detection of clinically significant pneumothorax for early intervention and an absence of pneumothorax at 4 hours can rule out the possibility of delayed pneumothorax at a later time point This may facilitate early discharge in at least 80 of patients
This prospective study aims to evaluate the diagnostic capacity of a 4-hour CXR after image-guided TTLB in predicting the clinically significant pneumothorax at 16 to 20 hours after biopsy The investigators hypothesized that an absence of pneumothorax on CXR at 4 hours can accurately predict an absence of clinically significant pneumothorax at 16 to 20 hours As the best way of measuring the size of iatrogenic pneumothorax has not been defined several pragmatic methods with arbitrary cutoff values will be assessed in the study including a binary outcome of pneumothorax present or absent apex-to-cupula distance 2 cm or 2 cm width of pneumothorax at the hilar level 1 cm or 1 cm Lights method 10 or 10 11 and Collins method 10 or 10 12 The data collected from this study will provide evidence regarding the safety and patient selection for same-day discharge in patients undergoing image-guided TTLB
The majority of post-TTLB iatrogenic pneumothorax occurs immediately after the procedure but delayed pneumothorax which happened hours after the biopsy is a recognized complication The incidence rate of delayed pneumothorax ranges between 04 and 86 and mostly could be detected at or within 4 hours after biopsy Among these delayed pneumothorax up to 60 were clinically significant and required chest drain insertion
There is no high-quality evidence informing physicians of the best timing of CXR in detecting delayed pneumothorax An ideal timing for this CXR should be late enough to capture the most delayed clinically significant pneumothorax yet promptly detect deterioration due to pneumothorax The British Thoracic Society guideline recommends an erect CXR 1 hour after the biopsy which is sufficient to detect the majority of post-biopsy pneumothorax The guideline also mentions that patients should be warned of delayed pneumothorax but does not mandate the need for subsequent CXR Overnight observation with a CXR the next day ie 16 to 20 hours after biopsy is a common local practice to detect the occurrence of delayed pneumothorax This practice although safe has not been examined extensively and involves a longer hospital stay for all patients receiving TTLB TTLB as a day procedure has been described instead A series of CXRs were used to ensure adequate detection of enlarging iatrogenic pneumothorax but it was labour-intensive
Our group conducted an internal audit covering 3 months of hospital data in Prince of Wales Hospital which includes 109 patients who underwent image-guided TTLB between Nov 2023 and Jan 2024 The incidences of pneumothorax and clinically significant pneumothorax requiring chest drain insertion were 23 211 and 7 64 respectively Among those patients who had chest drain insertion 4 had drains inserted within 3 hours after biopsy The remaining 3 patients had chest drains inserted at 16 to 19 hours after biopsy Their initial CXR at 1 hour showed no pneumothorax but did not receive interim CXR in between A separate group of 11 patients with CXR between 3 to 6 hours and no clinically significant pneumothorax were safely discharged the next day These preliminary data suggest that an interim CXR at 4 hours may allow timely detection of clinically significant pneumothorax for early intervention and an absence of pneumothorax at 4 hours can rule out the possibility of delayed pneumothorax at a later time point This may facilitate early discharge in at least 80 of patients
This prospective study aims to evaluate the diagnostic capacity of a 4-hour CXR after image-guided TTLB in predicting the clinically significant pneumothorax at 16 to 20 hours after biopsy The investigators hypothesized that an absence of pneumothorax on CXR at 4 hours can accurately predict an absence of clinically significant pneumothorax at 16 to 20 hours As the best way of measuring the size of iatrogenic pneumothorax has not been defined several pragmatic methods with arbitrary cutoff values will be assessed in the study including a binary outcome of pneumothorax present or absent apex-to-cupula distance 2 cm or 2 cm width of pneumothorax at the hilar level 1 cm or 1 cm Lights method 10 or 10 11 and Collins method 10 or 10 12 The data collected from this study will provide evidence regarding the safety and patient selection for same-day discharge in patients undergoing image-guided TTLB
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None