Isala Klinieken
Zwolle, Overijssel, 8025AB, Netherlands
NCT Number: NCT05180955
The study will be conducted as a, prospective, open label, non-inferiority, randomized controlled trial. In the intervention group; chest tube removal will be determined by air flow criteria as indicated by the digital drainage system data. In the control group removal will be determined by the same criteria of the digital drainage system but before removal, a chest tube clamping test will be performed. Primary outcome measure: recurrent pneumothorax after chest tube removal requiring chest tube reinsertion
Looking for future studies?
Notify Me18 year and older
All sexes
Interventional
Not applicable
Zwolle, Overijssel, 8025AB, Netherlands
Determining and timing of chest tube removal has been a continuous topic of debate amongst both surgeons and pulmonologist. It is plausible that provocative clamping tests are no longer necessary when a digital continuous recording drainage device is used that demonstrates the absence of (intermittent) air leak. However, clamping trials are still performed in clinical care, it is an expert opinion's policy prompted by fear of recurrent pneumothorax and no comparative studies exist. We hypothesize that chest tube removal exclusively based on digital drainage system data is as safe as adding a clamping test before removal in patients treated for pneumothorax or after lung surgery.
The study will be conducted as a, prospective, open label, non-inferiority, randomized controlled trial. In the intervention group; chest tube removal will be determined by air flow criteria as indicated by the digital drainage system data. In the control group removal will be determined by the same criteria of the digital drainage system but before removal, a chest tube clamping test will be performed.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
In the intervention group; chest tube removal will be determined by air flow criteria as indicated by the digital drainage system data, the tube will not be clamped.
In the control group removal will be determined by the same criteria of the digital drainage system but before removal, a chest tube clamping test will be performed.
Time frame: 0-24 hours after drain removal
number of patients requiring chest tube reinsertion within 24 hours after chest tube removal for recurrent pneumothorax
Isala
Other
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.
Published trials that share one or more normalized conditions with this study.
NCT04848727
Atelectasis Neonatal, Pleural Diseases
San Diego, California, United States
View Trial DetailsNCT05963945
Atelectasis, Cardiomegaly
Havířov, Czechia
View Trial DetailsNCT03098524
Atelectasis, Bleeding
Neuilly-sur-Seine, Île-de-France Region, France
View Trial DetailsNCT07300072
Lung Nodules, Pleural Diseases
Taichung, Taiwan
View Trial Details