Ignite Creation Date:
2025-12-24 @ 6:37 PM
Ignite Modification Date:
2025-12-29 @ 5:45 PM
Study NCT ID:
NCT01775657
Status:
COMPLETED
Last Update Posted:
2022-11-21
First Post:
2012-11-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Digital Versus Analog Pleural Drainage Following Pulmonary Resection
Sponsor:
Ottawa Hospital Research Institute
Organization:
Study Overview
Official Title:
Digital Versus Analog Pleural Drainage Following Pulmonary Resection
Status:
COMPLETED
Status Verified Date:
2022-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DiVA Phase II
Brief Summary:
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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
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?: