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

Ottawa Hospital Research Institute

Status: Completed

Conditions: Wedge Resection; Pulmonary Air Leak; Lobectomy; Segmentectomy

Treatments: Device: Pleur Evac (Analogue drainage); Device: Thopaz (Digital drainage)

Study type: Interventional

Funder types: Other

Identifiers

NCT01775657

20120228-01H

Details and patient eligibility

About

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.

Enrollment: 176 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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176 participants in 4 patient groups

Air leak present - Analogue

Experimental group

Description:

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

Treatment:

Device: Pleur Evac (Analogue drainage)

Air leak absent - Analogue (Pleur Evac)

Active Comparator group

Description:

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

Treatment:

Device: Pleur Evac (Analogue drainage)

Air leak present - Digital (Thopaz)

Experimental group

Description:

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

Treatment:

Device: Thopaz (Digital drainage)

Air leak absent - Digital (Thopaz)

Active Comparator group

Description:

Patients randomized to digital system, no air leak present.

Treatment:

Device: Thopaz (Digital drainage)