Digital Air Leak Monitoring for Patients Undergoing Lung Resection

Nova Scotia Health Authority (NSHA)

Status: Completed

Conditions: Pneumothorax; Atelectasis

Treatments: Device: Dry suction pleura drainage device; Device: Digital pleural drainage system

Study type: Interventional

Funder types: Other

Identifiers

NCT01810172

CDHA-RS/2013-293

Details and patient eligibility

About

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.

Full 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?

Enrollment: 216 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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216 participants in 2 patient groups

Dry suction pleural drainage system

Active Comparator group

Description:

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

Treatment:

Device: Dry suction pleura drainage device

Digital pleural drainage system

Experimental group

Description:

The experimental group will have their chest tube connected to a digital pleural drainage. The intervention will be the digital pleural drainage system.

Treatment:

Device: Digital pleural drainage system