Digital Versus Analog Pleural Drainage Following Pulmonary Resection

Lobectomy Clinical Trial

— DiVA Phase II  

Official title:

Digital Versus Analog Pleural Drainage Following Pulmonary Resection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01775657
• Other study ID #: 20120228-01H
• Status: Completed
• Phase: N/A
• Start date: January 2013
• Est. completion date: December 1, 2021

Study information

• Verified date: November 2022
• Source: Ottawa Hospital Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 176
• Est. completion date: December 1, 2021
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lobectomy
• Pulmonary Air Leak
• Segmentectomy
• Wedge Resection

Intervention

Device:
• Thopaz (Digital drainage)

• Pleur Evac (Analogue drainage)

Locations

Country	Name	City	State
Canada	Ottawa Hospital, General Campus	Ottawa	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Ottawa Hospital Research Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall length of hospitalization		Up to 5 days post-op (average)
Secondary	Time to first pleural drain removal		Over 24 hours post-op