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Completed

NCT Number: NCT01810172

Digital Air Leak Monitoring for Patients Undergoing Lung Resection

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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Key information

Conditions

Pneumothorax Atelectasis Lung Diseases Pleural Diseases Pulmonary Atelectasis Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Capital Health District Authority

Halifax, Nova Scotia, B3H 2Y9, Canada

About this study

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?

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Digital pleural drainage system

Device

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

Other names: ATMOS pleural drainage system

Dry suction pleura drainage device

Device

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

Other names: Oasis dry suction water seal pleural drainage system

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Other outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Nova Scotia Health Authority

Other

Registry information

Official study title

Digital Air Leak Monitoring for Patients Undergoing Lung Resection: A Randomized Controlled Clinical Trial

Important dates

Study start
2013
Primary completion
2016
Study completion
2017
First posted
Mar 13, 2013
Registry last updated
Feb 1, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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