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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier:
NCT01775657
First received: November 29, 2012
Last updated: May 21, 2015
Last verified: May 2015
  Purpose

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 Intervention
Pulmonary Air Leak
Lobectomy
Wedge Resection
Segmentectomy
Device: Thopaz (Digital drainage)
Device: Pleur Evac (Analogue drainage)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Digital Versus Analog Pleural Drainage Following Pulmonary Resection

Further study details as provided by Ottawa Hospital Research Institute:

Primary Outcome Measures:
  • Overall length of hospitalization [ Time Frame: Up to 5 days post-op (average) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to first pleural drain removal [ Time Frame: Over 24 hours post-op ] [ Designated as safety issue: No ]

Enrollment: 176
Study Start Date: January 2013
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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, Reseach 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, Reseach 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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  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: 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
  More Information

No publications provided

Responsible Party: Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier: NCT01775657     History of Changes
Other Study ID Numbers: 20120228-01H
Study First Received: November 29, 2012
Last Updated: May 21, 2015
Health Authority: Canada: Ethics Review Committee

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

ClinicalTrials.gov processed this record on July 01, 2015