Atelectasis, Pneumothorax
Conditions
Keywords
lobectomy, segmentectomy, pneumothorax, pleural, digital, air leak
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.
Detailed description
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?
Interventions
DEVICEDigital pleural drainage system
Reusable device with disposable collection system for digital monitoring of air leak.
DEVICEDry suction pleura drainage device
Disposable dry suction operating system. Collects pleural fluid and monitors for air leak.
Sponsors
Nova Scotia Health Authority
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients 18 or older * Patients undergoing a lobectomy or segmentectomy
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| length of hospital stay | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| duration of chest tube insertion | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| post chest tube removal complications | one year | 1. 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. 2. Presence of atelectasis as determined by the dictating radiologist on chest x-ray from the second post-operative day. 3. Need for chest tube re-insertion. |
Countries
Canada
Outcome results
None listed