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

This study is currently recruiting participants.
Verified April 2014 by Ottawa Hospital Research Institute
Sponsor:
Information provided by (Responsible Party):
Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier:
NCT01775657
First received: November 29, 2012
Last updated: April 2, 2014
Last verified: April 2014
  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 80 patients in each group (digital and analogue).

Hypothesis: Continuous, quantitative monitoring of PAL following lung resection leads to more efficient chest tube management as measured by 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 (Phase II)

Further study details as provided by Ottawa Hospital Research Institute:

Primary Outcome Measures:
  • Time to first pleural drain removal [ Time Frame: Over 24 hours post-op ] [ Designated as safety issue: No ]
    Patient must still have pleural drain, 24 hours post op, with no plans to remove before 36 hours post op.


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

Estimated Enrollment: 160
Study Start Date: January 2013
Estimated Primary Completion Date: December 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:

  • Age ≥ 18 years
  • Pulmonary resection for Benign or Neoplastic diagnosis (includes lobectomy, segmentectomy or wedge resection)
  • Patient must be alert, and oriented to time, person and place

Exclusion Criteria:

  • Tension pneumothorax
  • Traumatic or iatrogenic pneumothorax
  • Primary or recurrent spontaneous pneumothorax awaiting surgery
  • Pneumonectomy patient (history of or current treatment)
  • Inability to provide informed consent:
  • Altered mental status from narcotics, general anesthesia, severe systemic illness
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01775657

Contacts
Contact: Sebastien Gilbert, MD 613-737-8899 ext 74033 sgilbert@ohri.ca

Locations
Canada, Ontario
Ottawa Hospital, General Campus Recruiting
Ottawa, Ontario, Canada, K1H8L6
Contact: Sebastien Gilbert, MD    613-737-8899 ext 74033      
Sub-Investigator: Anna McGuire, MD         
Sub-Investigator: Andrew JE Seely, MD, PhD         
Principal Investigator: Sebastien Gilbert, MD         
Sub-Investigator: Donna Maziak, MD, FRCSC         
Sub-Investigator: Sudhir Sundaresan, MD, FRCSC         
Sub-Investigator: Farid Shamji, MD, FRCSC         
Sub-Investigator: Villeneuve P James, MD, FRCSC         
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: April 2, 2014
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 April 22, 2014