Digital Air Leak Monitoring for Patients Undergoing Lung Resection

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

216 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-30

Study Completion Date

2017-01-31

Brief Summary

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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.

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Detailed Description

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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?

Conditions

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Pneumothorax Atelectasis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type ACTIVE_COMPARATOR

Dry suction pleura drainage device

Intervention Type DEVICE

Disposable dry suction operating system. Collects pleural fluid and monitors for air leak.

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.

Group Type EXPERIMENTAL

Digital pleural drainage system

Intervention Type DEVICE

Reusable device with disposable collection system for digital monitoring of air leak.

Interventions

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Digital pleural drainage system

Reusable device with disposable collection system for digital monitoring of air leak.

Intervention Type DEVICE

Dry suction pleura drainage device

Disposable dry suction operating system. Collects pleural fluid and monitors for air leak.

Intervention Type DEVICE

Other Intervention Names

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ATMOS pleural drainage system Oasis dry suction water seal pleural drainage system

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No