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DiVA Phase II: Digital Versus Analog Pleural Drainage Following Pulmonary Resection

Sponsor
Ottawa Hospital Research Institute (Other)
Overall Status
Unknown status
CT.gov ID
NCT01775657
Collaborator
(none)
176
Enrollment
1
Location
4
Arms
95
Duration (Months)
1.9
Patients Per Site Per Month

Study Details

Study Description

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
  • Device: Thopaz (Digital drainage)
  • Device: Pleur Evac (Analogue drainage)
 N/A

Study Design

Study Type:
Interventional
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 :
Jan 1, 2013
Actual Primary Completion Date :
May 1, 2014
Anticipated Study Completion Date :
Dec 1, 2020

Arms and Interventions

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 Names:
  • 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 Names:
  • 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 Names:
  • Thopaz, Medela Switzerland

    		•
    Active Comparator: Air leak absent - Digital (Thopaz)

    Patients randomized to digital system, no air leak present.

    Device: Thopaz (Digital drainage)
    Other Names:
  • Thopaz, Medela Switzerland

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Overall length of hospitalization [Up to 5 days post-op (average)]

    Secondary Outcome Measures

    1. Time to first pleural drain removal [Over 24 hours post-op]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ottawa Hospital Research Institute
    ClinicalTrials.gov Identifier:
    NCT01775657
    Other Study ID Numbers:
    • 20120228-01H
    First Posted:
    Jan 25, 2013
    Last Update Posted:
    Mar 9, 2020
    Last Verified:
    Mar 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Keywords provided by Ottawa Hospital Research Institute
    pulmonary air leak
    Thopaz
    digital
    analog
    randomized

    Study Results

    No Results Posted as of Mar 9, 2020