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OpenTrials
Completed

NCT Number: NCT01775657

Digital Versus Analog Pleural Drainage Following Pulmonary Resection

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.

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Key information

Conditions

Pulmonary Air Leak Lobectomy Segmentectomy Wedge Resection

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ottawa Hospital, General Campus

Ottawa, Ontario, K1H8L6, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Thopaz (Digital drainage)

Device

Other names: Thopaz, Medela Switzerland

Pleur Evac (Analogue drainage)

Device

Other names: Pleur Evac A-6002-08, Teleflex Inc, Research Triangle Park, NC, USA

Primary outcomes

  1. Overall length of hospitalization

    Time frame: Up to 5 days post-op (average)

Secondary outcomes

  1. Time to first pleural drain removal

    Time frame: Over 24 hours post-op

Sponsors and collaborators

Lead sponsor

Ottawa Hospital Research Institute

Other

Registry information

Acronym: DiVA Phase II

Important dates

Study start
2013
Primary completion
2014
Study completion
2021
First posted
Jan 25, 2013
Registry last updated
Nov 21, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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