Digital Air Leak Monitoring for Patients Undergoing Lung Resection
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01810172|
Recruitment Status : Completed
First Posted : March 13, 2013
Last Update Posted : February 1, 2017
|Condition or disease||Intervention/treatment||Phase|
|Pneumothorax Atelectasis||Device: Digital pleural drainage system Device: Dry suction pleura drainage device||Not Applicable|
Technology has become a driving force in surgery. From robotics to digital monitoring of oxygen saturation, it has revolutionized the way we care for patients. However, new technology comes at a cost to our healthcare system. It is therefore important to ensure that new devices actually improve outcomes. One example of this is minimally invasive surgery, which decreases morbidity to patients and reduces length of hospital stay. Unfortunately, despite this advance in lung surgery, delays in discharge from hospital are still prevalent due to prolonged air leaks. Many intra-operative methods have been explored in order to limit this issue with underwhelming success. This is why we are proposing a randomized controlled trial comparing a digital pleural collection system by ATMOS to traditional pleural collection devices by Atrium.
Our research question is: Can the use of a digital air leak monitoring system decrease hospital stay in patients undergoing anatomical lung resection when compared to traditional pleural drainage systems?
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||216 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Digital Air Leak Monitoring for Patients Undergoing Lung Resection: A Randomized Controlled Clinical Trial|
|Study Start Date :||April 2013|
|Actual Primary Completion Date :||April 2016|
|Actual Study Completion Date :||January 2017|
Active Comparator: Dry suction pleural drainage system
The 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
Device: Dry suction pleura drainage device
Disposable dry suction operating system. Collects pleural fluid and monitors for air leak.
Other Name: Oasis dry suction water seal pleural drainage system
Experimental: Digital pleural drainage system
The experimental group will have their chest tube connected to a digital pleural drainage. The intervention will be the digital pleural drainage system.
Device: Digital pleural drainage system
Reusable device with disposable collection system for digital monitoring of air leak.
Other Name: ATMOS pleural drainage system
- length of hospital stay [ Time Frame: one year ]
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.
- duration of chest tube insertion [ Time Frame: one year ]The duration of chest tube drainage which will also be measured in days from the time of insertion in the operating room until they are removed.
- post chest tube removal complications [ Time Frame: one year ]
- Post-chest tube removal pneumothorax. A significant pneumothorax will be defined as the presence of a space greater than 2cm at the apex and lateral aspect of the lung.
- Presence of atelectasis as determined by the dictating radiologist on chest x-ray from the second post-operative day.
- Need for chest tube re-insertion.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01810172
|Canada, Nova Scotia|
|Capital Health District Authority|
|Halifax, Nova Scotia, Canada, B3H 2Y9|
|Principal Investigator:||Madelaine M Plourde, MD,MSc,FRCSC||CDHA|