Lobectomy, Pulmonary Air Leak, Segmentectomy, Wedge Resection
Conditions
Keywords
pulmonary air leak, Thopaz, digital, analog, randomized
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.
Interventions
DEVICEThopaz (Digital drainage)
DEVICEPleur Evac (Analogue drainage)
Sponsors
Ottawa Hospital Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall length of hospitalization | Up to 5 days post-op (average) |
Secondary
| Measure | Time frame |
|---|---|
| Time to first pleural drain removal | Over 24 hours post-op |
Countries
Canada
Outcome results
None listed