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

November 18, 2022 updated by: Ottawa Hospital Research Institute

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

176

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Ottawa, Ontario, Canada, K1H8L6
        • Ottawa Hospital, General Campus

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall length of hospitalization
Time Frame: Up to 5 days post-op (average)
Up to 5 days post-op (average)

Secondary Outcome Measures

Outcome Measure
Time Frame
Time to first pleural drain removal
Time Frame: Over 24 hours post-op
Over 24 hours post-op

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ottawa Hospital Research Institute

Investigators

  • Principal Investigator: Sebastien Gilbert, MD, Ottawa Hospital Research Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (Actual)

May 1, 2014

Study Completion (Actual)

December 1, 2021

Study Registration Dates

First Submitted

November 29, 2012

First Submitted That Met QC Criteria

January 24, 2013

First Posted (Estimate)

January 25, 2013

Study Record Updates

Last Update Posted (Actual)

November 21, 2022

Last Update Submitted That Met QC Criteria

November 18, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 20120228-01H

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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