Digital Versus Analog Pleural Drainage Following Pulmonary Resection

NCT01775657 | Completed DMC

• 1 other identifier: 20120228-01H
• Study Type: interventional
• Target: 176
• Locations: 1 country
• Sites: 1

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.

Conditions

Pulmonary Air Leak; Lobectomy; Wedge Resection; Segmentectomy

Keywords

pulmonary air leak; Thopaz; digital; analog; randomized

Outcome Measures

Primary Outcomes (1)

• Overall length of hospitalization

  Up to 5 days post-op (average)

Secondary Outcomes (1)

• Time to first pleural drain removal

  Over 24 hours post-op

Study Arms (4)

Air leak present - Analogue

EXPERIMENTAL

Patients randomized to Pleur Evac (Analogue drainage) monitoring system, air leak present.

Device: Pleur Evac (Analogue drainage)

Air leak absent - Analogue (Pleur Evac)

ACTIVE COMPARATOR

Patients randomized to Pleur Evac (Analogue drainage) monitoring system, no air leak present

Device: Pleur Evac (Analogue drainage)

Air leak present - Digital (Thopaz)

EXPERIMENTAL

Patients with an air leak present, randomized to Thopaz (digital drainage) monitoring system.

Device: Thopaz (Digital drainage)

Air leak absent - Digital (Thopaz)

ACTIVE COMPARATOR

Patients randomized to digital system, no air leak present.

Device: Thopaz (Digital drainage)

Interventions

Thopaz (Digital drainage) DEVICE

Also known as: Thopaz, Medela Switzerland

Air leak absent - Digital (Thopaz); Air leak present - Digital (Thopaz)

Pleur Evac (Analogue drainage) DEVICE

Also known as: Pleur Evac A-6002-08, Teleflex Inc, Research Triangle Park, NC, USA

Air leak absent - Analogue (Pleur Evac); Air leak present - Analogue

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ottawa Hospital Research Institute: lead

Study Sites (1)

Ottawa Hospital, General Campus

Ottawa, Ontario, K1H8L6, Canada

Location

Related Publications (1)

• Gilbert S, McGuire AL, Maghera S, Sundaresan SR, Seely AJ, Maziak DE, Shamji FM, Villeneuve PJ. Randomized trial of digital versus analog pleural drainage in patients with or without a pulmonary air leak after lung resection. J Thorac Cardiovasc Surg. 2015 Nov;150(5):1243-9. doi: 10.1016/j.jtcvs.2015.08.051. Epub 2015 Aug 28.

  PMID: 26409729 DERIVED

Study Officials

• Sebastien Gilbert, MD

  Ottawa Hospital Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2012
• First Posted: January 25, 2013
• Study Start: January 1, 2013
• Primary Completion: May 1, 2014
• Study Completion: December 1, 2021
• Last Updated: November 21, 2022

Record last verified: 2022-11

Locations

CA (1)