Digital Air Leak Monitoring for Patients Undergoing Lung Resection

Atelectasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01810172
• Other study ID #: CDHA-RS/2013-293
• Status: Completed
• Phase: N/A
• First received: March 11, 2013
• Last updated: January 31, 2017
• Start date: April 2013
• Est. completion date: January 2017

Study information

• Verified date: January 2017
• Source: Nova Scotia Health Authority
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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?

Recruitment information / eligibility

• Status: Completed
• Enrollment: 216
• Est. completion date: January 2017
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atelectasis
• Pneumothorax
• Pulmonary Atelectasis

Intervention

Device:
• Digital pleural drainage system
Reusable device with disposable collection system for digital monitoring of air leak.
• Dry suction pleura drainage device
Disposable dry suction operating system. Collects pleural fluid and monitors for air leak.

Locations

Country	Name	City	State
Canada	Capital Health District Authority	Halifax	Nova Scotia

Sponsors (1)

Lead Sponsor	Collaborator
Nova Scotia Health Authority

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	post chest tube removal complications	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.	one year
Primary	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.	one year
Secondary	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.	one year