Clinical Efficacy and Safety of an Automatic Closed-Suction System in Mechanically Ventilated Patients with Pneumonia: A Multicenter, Prospective, Randomized, Non-Inferiority, Investigator-Initiated Trial
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Published:2024-05-21
Issue:11
Volume:14
Page:1068
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ISSN:2075-4418
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Container-title:Diagnostics
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language:en
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Short-container-title:Diagnostics
Author:
Joo Dong-Hyun1, Park Hyo Chan12ORCID, Kim Joon Han1, Yang Seo Hee1ORCID, Kim Tae Hun1, Kim Hyung-Jun1ORCID, Song Myung Jin1, Lim Sung Yoon1ORCID, Kim Sung A3, Bae Hee Won3, Ahn Yoon Hae4, Yoon Si Mong4ORCID, Park Jimyung3, Lee Hong Yeul4ORCID, Lee Jinwoo3ORCID, Lee Sang-Min34ORCID, Lee Jung Chan5ORCID, Cho Young-Jae1ORCID
Affiliation:
1. Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Seoul National University College of Medicine, Seoul National University Bundang Hospital, Seongnam 13620, Republic of Korea 2. Department of Medical Device Development, Seoul National University College of Medicine, Seoul 03080, Republic of Korea 3. Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Seoul National University College of Medicine, Seoul National University Hospital, Seoul 03080, Republic of Korea 4. Department of Critical Care Medicine, Seoul National University Hospital, Seoul 03080, Republic of Korea 5. Department of Biomedical Engineering, Institute of Medical and Biological Engineering, Medical Research Center, Seoul National University College of Medicine, Seoul 03080, Republic of Korea
Abstract
Endotracheal suctioning is an essential but labor-intensive procedure, with the risk of serious complications. A brand new automatic closed-suction device was developed to alleviate the workload of healthcare providers and minimize those complications. We evaluated the clinical efficacy and safety of the automatic suction system in mechanically ventilated patients with pneumonia. In this multicenter, randomized, non-inferiority, investigator-initiated trial, mechanically ventilated patients with pneumonia were randomized to the automatic device (intervention) or conventional manual suctioning (control). The primary efficacy outcome was the change in the modified clinical pulmonary infection score (CPIS) in 3 days. Secondary outcomes were the frequency of additional suctioning and the amount of secretion. Safety outcomes included adverse events or complications. A total of 54 participants, less than the pre-determined number of 102, were enrolled. There was no significant difference in the change in the CPIS over 72 h (−0.13 ± 1.58 in the intervention group, −0.58 ± 1.18 in the control group, p = 0.866), but the non-inferiority margin was not satisfied. There were no significant differences in the secondary outcomes and safety outcomes, with a tendency for more patients with improved tracheal mucosal injury in the intervention group. The novel automatic closed-suction system showed comparable efficacy and safety compared with conventional manual suctioning in mechanically ventilated patients with pneumonia.
Funder
Korea’s Medical Device Developmental fund L-MECA Co., Ltd.
Reference21 articles.
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