Digital Versus Analog Pleural Drainage Following Pulmonary Resection

Not Applicable

Completed

• Conditions: Wedge Resection; Segmentectomy; Pulmonary Air Leak; Lobectomy
• Interventions: Device: Thopaz (Digital drainage); Device: Pleur Evac (Analogue drainage)

• Registration Number: NCT01775657
• Lead Sponsor: Ottawa Hospital Research Institute

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-11-29
• Study Start: 2013-01
• Study First Submitted QC: 2013-01-24
• Study First Posted: 2013-01-25
• Primary Completion: 2014-05
• Study Completion: 2021-12-01
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-18
• Last Update Posted: 2022-11-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 176

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Air leak present - Digital (Thopaz)	Thopaz (Digital drainage)	Patients with an air leak present, randomized to Thopaz (digital drainage) monitoring system.
Air leak absent - Analogue (Pleur Evac)	Pleur Evac (Analogue drainage)	Patients randomized to Pleur Evac (Analogue drainage) monitoring system, no air leak present
Air leak absent - Digital (Thopaz)	Thopaz (Digital drainage)	Patients randomized to digital system, no air leak present.
Air leak present - Analogue	Pleur Evac (Analogue drainage)	Patients randomized to Pleur Evac (Analogue drainage) monitoring system, air leak present.

Primary Outcome Measures

Name	Time	Method
Overall length of hospitalization	Up to 5 days post-op (average)

Secondary Outcome Measures

Name	Time	Method
Time to first pleural drain removal	Over 24 hours post-op

Trial Locations

Locations (1)

Ottawa Hospital, General Campus; 🇨🇦 Ottawa, Ontario, Canada