ClinicalTrials.gov
ClinicalTrials.gov Menu

Digital Versus Analog Pleural Drainage Following Pulmonary Resection (DiVA Phase II)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01775657
Recruitment Status : Active, not recruiting
First Posted : January 25, 2013
Last Update Posted : June 12, 2017
Sponsor:
Information provided by (Responsible Party):
Ottawa Hospital Research Institute

Brief Summary:

This study will evaluate the impact of continuous, digital pulmonary air leak monitoring on the duration of pleural drainage after lung resection in patients with and without a pulmonary air leak on postoperative day 1.

Patients undergoing pulmonary resection who fit the inclusion criteria will be identified pre-operatively. Patients within two groups (air leak and no air leak) will be randomized to receive either the analogue system or the digital system. Both systems are approved for use in hospitals by Health Canada. There will be 88 patients in each air leak group.

Hypothesis: Continuous, quantitative monitoring of PAL following lung resection leads to an improvement in primary outcomes.


Condition or disease Intervention/treatment Phase
Pulmonary Air Leak Lobectomy Wedge Resection Segmentectomy Device: Thopaz (Digital drainage) Device: Pleur Evac (Analogue drainage) Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 176 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Digital Versus Analog Pleural Drainage Following Pulmonary Resection
Study Start Date : January 2013
Actual Primary Completion Date : May 2014
Estimated Study Completion Date : August 2019

Arm Intervention/treatment
Experimental: Air leak present - Analogue
Patients randomized to Pleur Evac (Analogue drainage) monitoring system, air leak present.
Device: Pleur Evac (Analogue drainage)
Other Name: Pleur Evac A-6002-08, Teleflex Inc, Research Triangle Park, NC, USA

Active Comparator: Air leak absent - Analogue (Pleur Evac)
Patients randomized to Pleur Evac (Analogue drainage) monitoring system, no air leak present
Device: Pleur Evac (Analogue drainage)
Other Name: Pleur Evac A-6002-08, Teleflex Inc, Research Triangle Park, NC, USA

Experimental: Air leak present - Digital (Thopaz)
Patients with an air leak present, randomized to Thopaz (digital drainage) monitoring system.
Device: Thopaz (Digital drainage)
Other Name: Thopaz, Medela Switzerland

Active Comparator: Air leak absent - Digital (Thopaz)
Patients randomized to digital system, no air leak present.
Device: Thopaz (Digital drainage)
Other Name: Thopaz, Medela Switzerland




Primary Outcome Measures :
  1. Overall length of hospitalization [ Time Frame: Up to 5 days post-op (average) ]

Secondary Outcome Measures :
  1. Time to first pleural drain removal [ Time Frame: Over 24 hours post-op ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Elective pulmonary resection (i.e. wedge, segmentectomy, lobectomy, bilobectomy) for benign or neoplastic disease

Exclusion Criteria:

  1. Development of tension pneumothorax
  2. Pneumonectomy
  3. Patient no longer within planned randomization window
  4. Plan to remove or removal of all chest drains within 36 hours of surgery
  5. Inability to provide informed consent
  6. Age < 18 years
  7. Patient was previously randomized following pulmonary resection

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01775657


Locations
Canada, Ontario
Ottawa Hospital, General Campus
Ottawa, Ontario, Canada, K1H8L6
Sponsors and Collaborators
Ottawa Hospital Research Institute
Investigators
Principal Investigator: Sebastien Gilbert, MD Ottawa Hospital Research Institute

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier: NCT01775657     History of Changes
Other Study ID Numbers: 20120228-01H
First Posted: January 25, 2013    Key Record Dates
Last Update Posted: June 12, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Ottawa Hospital Research Institute:
pulmonary air leak
Thopaz
digital
analog
randomized