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Digital Air Leak Monitoring for Patients Undergoing Lung Resection

Primary Purpose

Pneumothorax, Atelectasis

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Digital pleural drainage system
Dry suction pleura drainage device
Sponsored by
Nova Scotia Health Authority
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pneumothorax focused on measuring lobectomy, segmentectomy, pneumothorax, pleural, digital, air leak

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Capital Health District Authority

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Dry suction pleural drainage system

Digital pleural drainage system

Arm 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

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

Outcomes

Primary Outcome Measures

length of hospital stay
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
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.

Full Information

First Posted
March 11, 2013
Last Updated
January 31, 2017
Sponsor
Nova Scotia Health Authority
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1. Study Identification

Unique Protocol Identification Number
NCT01810172
Brief Title
Digital Air Leak Monitoring for Patients Undergoing Lung Resection
Official Title
Digital Air Leak Monitoring for Patients Undergoing Lung Resection: A Randomized Controlled Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
April 2013 (undefined)
Primary Completion Date
April 2016 (Actual)
Study Completion Date
January 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nova Scotia Health Authority

4. Oversight

Data Monitoring Committee
No

5. Study Description

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?

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pneumothorax, Atelectasis
Keywords
lobectomy, segmentectomy, pneumothorax, pleural, digital, air leak

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
216 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dry suction pleural drainage system
Arm Type
Active Comparator
Arm 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
Arm Title
Digital pleural drainage system
Arm Type
Experimental
Arm Description
The experimental group will have their chest tube connected to a digital pleural drainage. The intervention will be the digital pleural drainage system.
Intervention Type
Device
Intervention Name(s)
Digital pleural drainage system
Other Intervention Name(s)
ATMOS pleural drainage system
Intervention Description
Reusable device with disposable collection system for digital monitoring of air leak.
Intervention Type
Device
Intervention Name(s)
Dry suction pleura drainage device
Other Intervention Name(s)
Oasis dry suction water seal pleural drainage system
Intervention Description
Disposable dry suction operating system. Collects pleural fluid and monitors for air leak.
Primary Outcome Measure Information:
Title
length of hospital stay
Description
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.
Time Frame
one year
Secondary Outcome Measure Information:
Title
duration of chest tube insertion
Description
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.
Time Frame
one year
Other Pre-specified Outcome Measures:
Title
post chest tube removal complications
Description
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.
Time Frame
one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Madelaine M Plourde, MD,MSc,FRCSC
Organizational Affiliation
CDHA
Official's Role
Principal Investigator
Facility Information:
Facility Name
Capital Health District Authority
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 2Y9
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

Digital Air Leak Monitoring for Patients Undergoing Lung Resection

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