Multicenter randomized study on the comparison between electronic and traditional chest drainage systems
Abstract Background In patients submitted to major pulmonary resection, the postoperative length of stay is mainly influenced by the duration of air leaks and chest tube removal. The measurement of air leaks largely relies on traditional chest drainage systems which are prone to subjective interpret...
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| Format: | Article |
| Language: | English |
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BMC
2019-12-01
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| Series: | Trials |
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| Online Access: | https://doi.org/10.1186/s13063-019-3811-8 |
| _version_ | 1818647765753790464 |
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| author | Giuseppe Marulli Giovanni M. Comacchio Mario Nosotti Lorenzo Rosso Paolo Mendogni Giuseppe Natale Luigi Andriolo Giovanna Imbriglio Valentina Larocca Debora Brascia Federico Rea |
| author_facet | Giuseppe Marulli Giovanni M. Comacchio Mario Nosotti Lorenzo Rosso Paolo Mendogni Giuseppe Natale Luigi Andriolo Giovanna Imbriglio Valentina Larocca Debora Brascia Federico Rea |
| author_sort | Giuseppe Marulli |
| collection | DOAJ |
| description | Abstract Background In patients submitted to major pulmonary resection, the postoperative length of stay is mainly influenced by the duration of air leaks and chest tube removal. The measurement of air leaks largely relies on traditional chest drainage systems which are prone to subjective interpretation. Difficulty in differentiating between active air leaks and bubbles due to a pleural space effect may also lead to tentative drain clamping and prolonged time for chest drain removal. New digital systems allow continuous monitoring of air leaks, identifying subtle leakage that may be not visible during daily patient evaluation. Moreover, an objective assessment of air leaks may lead to a reduced interobserver variability and to an optimized timing for chest tube removal. Methods This study is a prospective randomized, interventional, multicenter trial designed to compare an electronic chest drainage system (Drentech™ Palm Evo) with a traditional system (Drentech™ Compact) in a cohort of patients undergoing pulmonary lobectomy through a standard three-port video-assisted thoracic surgery approach for both benign and malignant disease. The study will enroll 382 patients in three Italian centers. The duration of chest drainage and the length of hospital stay will be evaluated in the two groups. Moreover, the study will evaluate whether the use of a digital chest system compared with a traditional system reduces the interobserver variability. Finally, it will evaluate whether the digital drain system may help in distinguishing an active air leak from a pleural space effect, by the digital assessment of intrapleural differential pressure, and in identifying potential predictors of prolonged air leaks. Discussion To date, few studies have been performed to evaluate the clinical impact of digital drainage systems. The proposed prospective randomized trial will provide new knowledge to this research area by investigating and comparing the difference between digital and traditional chest drain systems. In particular, the objectives of this project are to evaluate the feasibility and usefulness of digital chest drainages and to provide new tools to identify patients at higher risk of developing prolonged air leaks. Trial registration ClinicalTrials.gov, NCT03536130. Retrospectively registered on 24 May 2018. |
| first_indexed | 2024-12-17T01:07:44Z |
| format | Article |
| id | doaj.art-238689cc049148e1a0156fd433f803e0 |
| institution | Directory Open Access Journal |
| issn | 1745-6215 |
| language | English |
| last_indexed | 2024-12-17T01:07:44Z |
| publishDate | 2019-12-01 |
| publisher | BMC |
| record_format | Article |
| series | Trials |
| spelling | doaj.art-238689cc049148e1a0156fd433f803e02022-12-21T22:09:13ZengBMCTrials1745-62152019-12-012011810.1186/s13063-019-3811-8Multicenter randomized study on the comparison between electronic and traditional chest drainage systemsGiuseppe Marulli0Giovanni M. Comacchio1Mario Nosotti2Lorenzo Rosso3Paolo Mendogni4Giuseppe Natale5Luigi Andriolo6Giovanna Imbriglio7Valentina Larocca8Debora Brascia9Federico Rea10Thoracic Surgery Unit, Department of Organ Transplantation and Emergency, University Hospital of BariThoracic Surgery Unit, Department of Cardiologic, Thoracic and Vascular Sciences, University Hospital of PadovaThoracic Surgery Unit, Fondazione IRCCS Ca’ Granda Ospedale Maggiore Policlinico, University of MilanThoracic Surgery Unit, Fondazione IRCCS Ca’ Granda Ospedale Maggiore Policlinico, University of MilanThoracic Surgery Unit, Fondazione IRCCS Ca’ Granda Ospedale Maggiore Policlinico, University of MilanThoracic Surgery Unit, Department of Cardiologic, Thoracic and Vascular Sciences, University Hospital of PadovaThoracic Surgery Unit, ‘V Fazzi’ HospitalThoracic Surgery Unit, ‘V Fazzi’ HospitalThoracic Surgery Unit, ‘V Fazzi’ HospitalThoracic Surgery Unit, Department of Organ Transplantation and Emergency, University Hospital of BariThoracic Surgery Unit, Department of Cardiologic, Thoracic and Vascular Sciences, University Hospital of PadovaAbstract Background In patients submitted to major pulmonary resection, the postoperative length of stay is mainly influenced by the duration of air leaks and chest tube removal. The measurement of air leaks largely relies on traditional chest drainage systems which are prone to subjective interpretation. Difficulty in differentiating between active air leaks and bubbles due to a pleural space effect may also lead to tentative drain clamping and prolonged time for chest drain removal. New digital systems allow continuous monitoring of air leaks, identifying subtle leakage that may be not visible during daily patient evaluation. Moreover, an objective assessment of air leaks may lead to a reduced interobserver variability and to an optimized timing for chest tube removal. Methods This study is a prospective randomized, interventional, multicenter trial designed to compare an electronic chest drainage system (Drentech™ Palm Evo) with a traditional system (Drentech™ Compact) in a cohort of patients undergoing pulmonary lobectomy through a standard three-port video-assisted thoracic surgery approach for both benign and malignant disease. The study will enroll 382 patients in three Italian centers. The duration of chest drainage and the length of hospital stay will be evaluated in the two groups. Moreover, the study will evaluate whether the use of a digital chest system compared with a traditional system reduces the interobserver variability. Finally, it will evaluate whether the digital drain system may help in distinguishing an active air leak from a pleural space effect, by the digital assessment of intrapleural differential pressure, and in identifying potential predictors of prolonged air leaks. Discussion To date, few studies have been performed to evaluate the clinical impact of digital drainage systems. The proposed prospective randomized trial will provide new knowledge to this research area by investigating and comparing the difference between digital and traditional chest drain systems. In particular, the objectives of this project are to evaluate the feasibility and usefulness of digital chest drainages and to provide new tools to identify patients at higher risk of developing prolonged air leaks. Trial registration ClinicalTrials.gov, NCT03536130. Retrospectively registered on 24 May 2018.https://doi.org/10.1186/s13063-019-3811-8Traditional chest drainage systemsDigital chest drainageAir leakageChest tube removalLobectomy |
| spellingShingle | Giuseppe Marulli Giovanni M. Comacchio Mario Nosotti Lorenzo Rosso Paolo Mendogni Giuseppe Natale Luigi Andriolo Giovanna Imbriglio Valentina Larocca Debora Brascia Federico Rea Multicenter randomized study on the comparison between electronic and traditional chest drainage systems Trials Traditional chest drainage systems Digital chest drainage Air leakage Chest tube removal Lobectomy |
| title | Multicenter randomized study on the comparison between electronic and traditional chest drainage systems |
| title_full | Multicenter randomized study on the comparison between electronic and traditional chest drainage systems |
| title_fullStr | Multicenter randomized study on the comparison between electronic and traditional chest drainage systems |
| title_full_unstemmed | Multicenter randomized study on the comparison between electronic and traditional chest drainage systems |
| title_short | Multicenter randomized study on the comparison between electronic and traditional chest drainage systems |
| title_sort | multicenter randomized study on the comparison between electronic and traditional chest drainage systems |
| topic | Traditional chest drainage systems Digital chest drainage Air leakage Chest tube removal Lobectomy |
| url | https://doi.org/10.1186/s13063-019-3811-8 |
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