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| Name | Class |
|---|---|
| The Leeds Teaching Hospitals NHS Trust | OTHER |
| Yale University | OTHER |
| The University of Hong Kong | OTHER |
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with regulated suction mode | Experimental | 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. |
|
| regulated seal mode (-8 cmH2O). | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Switching level of suction | Procedure |
|
| Measure | Description | Time Frame |
|---|---|---|
| duration of air leak | up to 7 days |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ospedali Riuniti Ancona | Ancona | Italy |
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| Duration of chest tube left in the patient (days) | up to 7 days |
| Postoperative length of hospital stay (days) | up to 7 days |
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |