Effect of Regulated Pleural Pressure on Air Leak and Fluid Drainage Following Pulmonary Resections: A Multicenter Randomized Trial

Study Overview
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Brief Summary
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The objective of this randomized study is to compare the effect of two controlled chest tube protocols on the duration of air leak and fluid drainage following pulmonary lobectomy or segmentectomy by using an electronic regulated chest drainage system (Thopaz). Previous studies have suggested that the amount of negative pressure used at the level of the chest drainage device may affect the duration of air leak, but the results have been inconsistent, however as revealed in more recent studies understanding of the physics of chest drainage devices may have been confounded by lack of regulation of the pleural pressure. In addition, experimental studies have shown that fluid drainage may be affected by the degree of negative pleural pressure applied.

Official Title
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The Effect of Regulated Pleural Pressure on The Duration of Air Leak and Fluid Drainage Following Pulmonary Anatomic Resections: A Multicenter Randomized Trial

Conditions
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Lung Cancer

Intervention / Treatment
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* Procedure: Switching level of suction


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Able and willing to read, understand, and provide written Informed Consent; Age range of 18-90 years; Patients submitted to lobectomy, segmentectomy and bilobectomy due to lung cancer or other intrathoracic lesions. Both open and minimally invasive (thoracoscopic) resections are acceptable. Exclusion Criteria: if patients are submitted to lung resection associated with chest wall resection or diaphragm resection the patient will be excluded from analysis If during the postoperative hospital course there is a need for postoperative mechanical ventilation or hemodynamic instability the patient will be excluded from analysis. If the subject meets all of the inclusion criteria and none of the exclusion criteria, he/she is eligible to participate in the study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients with regulated suction mode<br>On the morning of each postoperative day (starting with POD#1) patients of group 1 are switched for 4 hours to -8 cm H2O After this period of 4 hours both groups are switched back to their original pressure levels, with the effect on air leak and fluid leak measured. Pts are then left on their original pressure level until the next day, when the switch to -8 or - 20 cm H2O is again made. | Procedure: Switching level of suction<br> <br> |
| Experimental: regulated seal mode (-8 cmH2O).<br>On the morning of each postoperative day (starting with POD#1) patients of group 1 are switched for 4 hours to -8 cm H2O and patients of group 2 are switched to -20 cm H2O. After this period of 4 hours both groups are switched back to their original pressure levels, with the effect on air leak and fluid leak measured. Pts are then left on their original pressure level until the next day, when the switch to -8 or - 20 cm H2O is again made. | Procedure: Switching level of suction<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| duration of air leak |  | up to 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1. Differences in airflow detected during the 4 hours after the pressure level is switched to -8 cmH2O or -20 cmH2O compared to the original pressure level in both groups |  | up to 5 days | 
| Differences in fluid drainage |  | up to 5 days | 
| Duration of chest tube left in the patient (days) |  | up to 7 days | 
| Postoperative length of hospital stay (days) |  | up to 7 days |