Digital Air Leak Monitoring for Patients Undergoing Lung Resection

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

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.

Study Overview

• Status: Completed
• Conditions: Pneumothorax; Atelectasis
• Intervention / Treatment: Device: Dry suction pleura drainage device; Device: Digital 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?

• Study Type: Interventional
• Enrollment (Actual): 216
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3H 2Y9
      • Capital Health District Authority

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: 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 Names: ATMOS pleural drainage system

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Nova Scotia Health Authority
• Investigators: Principal Investigator: Madelaine M Plourde, MD,MSc,FRCSC, CDHA

Study record dates

Study Major Dates

• Study Start: April 1, 2013
• Primary Completion (ACTUAL): April 1, 2016
• Study Completion (ACTUAL): January 1, 2017

Study Registration Dates

• First Submitted: March 11, 2013
• First Submitted That Met QC Criteria: March 12, 2013
• First Posted (ESTIMATE): March 13, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): February 1, 2017
• Last Update Submitted That Met QC Criteria: January 31, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Keywords: segmentectomy; lobectomy; air leak; pneumothorax; digital; pleural
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Pleural Diseases; Pneumothorax; Pulmonary Atelectasis
• Other Study ID Numbers: CDHA-RS/2013-293