Digital Versus Analog Pleural Drainage Following Pulmonary Resection
This trial is active, not recruiting.
|Conditions||pulmonary air leak, lobectomy, wedge resection, segmentectomy|
|Treatments||thopaz (digital drainage), pleur evac (analogue drainage)|
|Sponsor||Ottawa Hospital Research Institute|
|Start date||January 2013|
|End date||May 2014|
|Trial size||176 participants|
|Trial identifier||NCT01775657, 20120228-01H|
This study will evaluate the impact of continuous, digital pulmonary air leak monitoring on the duration of pleural drainage after lung resection in patients with and without a pulmonary air leak on postoperative day 1.
Patients undergoing pulmonary resection who fit the inclusion criteria will be identified pre-operatively. Patients within two groups (air leak and no air leak) will be randomized to receive either the analogue system or the digital system. Both systems are approved for use in hospitals by Health Canada. There will be 88 patients in each air leak group.
Hypothesis: Continuous, quantitative monitoring of PAL following lung resection leads to an improvement in primary outcomes.
|Intervention model||parallel assignment|
|Primary purpose||health services research|
Overall length of hospitalization
time frame: Up to 5 days post-op (average)
Time to first pleural drain removal
time frame: Over 24 hours post-op
Male or female participants at least 18 years old.
Inclusion Criteria: Elective pulmonary resection (i.e. wedge, segmentectomy, lobectomy, bilobectomy) for benign or neoplastic disease Exclusion Criteria: 1. Development of tension pneumothorax 2. Pneumonectomy 3. Patient no longer within planned randomization window 4. Plan to remove or removal of all chest drains within 36 hours of surgery 5. Inability to provide informed consent 6. Age < 18 years 7. Patient was previously randomized following pulmonary resection
|Official title||Digital Versus Analog Pleural Drainage Following Pulmonary Resection|
|Principal investigator||Sebastien Gilbert, MD|
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