Digital Air Leak Monitoring for Patients Undergoing Lung Resection
1 other identifier
interventional
216
1 country
1
Brief Summary
Often the decision for chest tube removal or trial of chest tube clamping is based on subjective assessment. This can lead to delay in chest tube removal. Recently, monitoring and recording of air leaks has been done using digital pleural drainage devices. This provides us with objective and continuous recording of air leaks as well as changes in pleural pressure. Our hypothesis is that the use of the ATMOS digital pleural drainage system will result in shorter hospital stay in comparison to traditional pleural drainage systems.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2013
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 11, 2013
CompletedFirst Posted
Study publicly available on registry
March 13, 2013
CompletedStudy Start
First participant enrolled
April 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2017
CompletedFebruary 1, 2017
January 1, 2017
3 years
March 11, 2013
January 31, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
length of hospital stay
The primary objective of this study will be the length of hospital stay from the day of surgery until the day of hospital discharge. The average length of hospital stay is 7 days. A subgroup analysis will be done to determine the impact of a video-assisted operative approach on length of stay and duration of chest tube drainage in comparison to thoracotomy.
one year
Secondary Outcomes (1)
duration of chest tube insertion
one year
Other Outcomes (1)
post chest tube removal complications
one year
Study Arms (2)
Dry suction pleural drainage system
ACTIVE COMPARATORThe control group will have their chest tube connected to a dry suction pleural drainage system The intervention will be the dry suction pleural drainage system
Digital pleural drainage system
EXPERIMENTALThe experimental group will have their chest tube connected to a digital pleural drainage. The intervention will be the digital pleural drainage system.
Interventions
Reusable device with disposable collection system for digital monitoring of air leak.
Disposable dry suction operating system. Collects pleural fluid and monitors for air leak.
Eligibility Criteria
You may qualify if:
- Patients 18 or older
- Patients undergoing a lobectomy or segmentectomy
You may not qualify if:
- Patients under the age of 18
- Patients undergoing pneumonectomy, wedge resection or bullectomy
- Patients who require additional procedures to control intraoperative air leak
- Patients who require mechanical ventilation post-operatively
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Capital Health District Authority
Halifax, Nova Scotia, B3H 2Y9, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Madelaine M Plourde, MD,MSc,FRCSC
CDHA
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Doctor
Study Record Dates
First Submitted
March 11, 2013
First Posted
March 13, 2013
Study Start
April 1, 2013
Primary Completion
April 1, 2016
Study Completion
January 1, 2017
Last Updated
February 1, 2017
Record last verified: 2017-01