Digital Air Leak Monitoring for Patients Undergoing Lung Resection

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified March 2013 by Capital District Health Authority, Canada
Sponsor:
Information provided by (Responsible Party):
Madelaine Plourde, Capital District Health Authority, Canada
ClinicalTrials.gov Identifier:
NCT01810172
First received: March 11, 2013
Last updated: March 19, 2013
Last verified: March 2013
  Purpose

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.


Condition Intervention
Pneumothorax
Atelectasis
Device: Digital pleural drainage system
Device: Dry suction pleura drainage device

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Digital Air Leak Monitoring for Patients Undergoing Lung Resection: A Randomized Controlled Clinical Trial

Resource links provided by NLM:


Further study details as provided by Capital District Health Authority, Canada:

Primary Outcome Measures:
  • length of hospital stay [ Time Frame: one year ] [ Designated as safety issue: No ]

    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 Outcome Measures:
  • duration of chest tube insertion [ Time Frame: one year ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • post chest tube removal complications [ Time Frame: one year ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 198
Study Start Date: April 2013
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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?

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01810172

Contacts
Contact: Madelaine M Plourde, MD,MSc,FRCSC 902-473-2281 mmplourde@gmail.com

Locations
Canada, Nova Scotia
Capital Health District Authority Not yet recruiting
Halifax, Nova Scotia, Canada, B3H 2Y9
Principal Investigator: Madelaine M Plourde, MD,MSc,FRCSC         
Sponsors and Collaborators
Capital District Health Authority, Canada
Investigators
Principal Investigator: Madelaine M Plourde, MD,MSc,FRCSC CDHA
  More Information

No publications provided

Responsible Party: Madelaine Plourde, Doctor, Capital District Health Authority, Canada
ClinicalTrials.gov Identifier: NCT01810172     History of Changes
Other Study ID Numbers: CDHA-RS/2013-293
Study First Received: March 11, 2013
Last Updated: March 19, 2013
Health Authority: Canada: Health Canada

Keywords provided by Capital District Health Authority, Canada:
lobectomy
segmentectomy
pneumothorax
pleural
digital
air leak

Additional relevant MeSH terms:
Pneumothorax
Pleural Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on October 23, 2014