Overview

This trial is active, not recruiting.

Conditions pulmonary air leak, lobectomy, wedge resection, segmentectomy
Treatments thopaz (digital drainage), pleur evac (analogue drainage)
Sponsor Ottawa Hospital Research Institute
Start date January 2013
End date May 2014
Trial size 176 participants
Trial identifier NCT01775657, 20120228-01H

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Primary purpose health services research
Arm
(Experimental)
Patients randomized to Pleur Evac (Analogue drainage) monitoring system, air leak present.
pleur evac (analogue drainage) Pleur Evac A-6002-08, Teleflex Inc, Reseach Triangle Park, NC, USA
(Active Comparator)
Patients randomized to Pleur Evac (Analogue drainage) monitoring system, no air leak present
pleur evac (analogue drainage) Pleur Evac A-6002-08, Teleflex Inc, Reseach Triangle Park, NC, USA
(Experimental)
Patients with an air leak present, randomized to Thopaz (digital drainage) monitoring system.
thopaz (digital drainage) Thopaz, Medela Switzerland
(Active Comparator)
Patients randomized to digital system, no air leak present.
thopaz (digital drainage) Thopaz, Medela Switzerland

Primary Outcomes

Measure
Overall length of hospitalization
time frame: Up to 5 days post-op (average)

Secondary Outcomes

Measure
Time to first pleural drain removal
time frame: Over 24 hours post-op

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Digital Versus Analog Pleural Drainage Following Pulmonary Resection
Principal investigator Sebastien Gilbert, MD
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Ottawa Hospital Research Institute.