Tessa Broadley, Ary Serpa Neto, Michael Bailey, Rinaldo Bellomo, Kathy Brickell, Heidi Buhr, Belinda J Gabbe, Doug W Gould, Meg Harrold, Sally Hurford, Theodore J Iwashyna, Alistair D Nichol, Jeffrey J Presneill, Stefan J Schaller, Janani Sivasuthan, Claire J Tipping, Steven Webb, Paul J Young, Alisa M Higgins, Carol L Hodgson
{"title":"早期动员期间和之后的不良事件：TEAM试验的事后分析。","authors":"Tessa Broadley, Ary Serpa Neto, Michael Bailey, Rinaldo Bellomo, Kathy Brickell, Heidi Buhr, Belinda J Gabbe, Doug W Gould, Meg Harrold, Sally Hurford, Theodore J Iwashyna, Alistair D Nichol, Jeffrey J Presneill, Stefan J Schaller, Janani Sivasuthan, Claire J Tipping, Steven Webb, Paul J Young, Alisa M Higgins, Carol L Hodgson","doi":"10.1016/j.aucc.2024.101156","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>The Treatment of Mechanically Ventilated Adults with Early Activity and Mobilisation (TEAM) trial reported a higher occurrence of adverse events with greater mobilisation. However, their timing and nature remained unexplored. We conducted an in-depth exploration of such events.</p><p><strong>Objective: </strong>The purpose of this paper is to thoroughly examine the timing and characteristics of adverse events reported within the TEAM trial.</p><p><strong>Methods: </strong>Adverse event data were collected daily in real time. Categorical data were compared using the Fisher's exact test. The relationship between adverse events and patient survival was analysed using a Cox-regression frailty model.</p><p><strong>Results: </strong>Overall, 37 out of 371 patients (10.0%) in the early mobilisation group and 16 out of 370 patients (4.3%) in the usual care group experienced adverse events, with 71 events in the early mobilisation group compared to 24 events in the usual care group. The most common adverse events were altered blood pressure in 21 out of 53 patients (39.6%), arrhythmia in 17 out of 53 patients (32.1%), and oxygen desaturation in nine of 53 patients (17.0%). Patients with an adverse event were more likely to have congestive heart failure (absolute percentage difference: 16.1, 95% confidence interval [CI]: 6.1 to 26.1), peripheral vascular disease (absolute percentage difference: 6.4, 95% CI: 1.3 to 11.5), heart attack (absolute percentage difference: 13.5, 95% CI: 5.9 to 21.1), or stroke (absolute percentage difference: 9.3, 95% CI: 3.5 to 15.1). Adverse events occurred at a median of 4 days with early mobilisation and 7 days with usual care. There was no significant difference in survival for patients who experienced an adverse event compared to those without an adverse event.</p><p><strong>Conclusion: </strong>Adverse events were more common in patients randomised to early active mobilisation, were cardiovascular and respiratory in nature, tended to occur earlier with active mobilisation, and cardiovascular comorbidities were more common in such patients. This information can help guide future studies in this field.</p><p><strong>Trial registration: </strong>TEAM ClinicalTrials.gov number, NCT03133377, registered 28 April 2017.</p>","PeriodicalId":51239,"journal":{"name":"Australian Critical Care","volume":"38 3","pages":"101156"},"PeriodicalIF":2.6000,"publicationDate":"2025-01-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Adverse events during and after early mobilisation: A post hoc analysis of the TEAM trial.\",\"authors\":\"Tessa Broadley, Ary Serpa Neto, Michael Bailey, Rinaldo Bellomo, Kathy Brickell, Heidi Buhr, Belinda J Gabbe, Doug W Gould, Meg Harrold, Sally Hurford, Theodore J Iwashyna, Alistair D Nichol, Jeffrey J Presneill, Stefan J Schaller, Janani Sivasuthan, Claire J Tipping, Steven Webb, Paul J Young, Alisa M Higgins, Carol L Hodgson\",\"doi\":\"10.1016/j.aucc.2024.101156\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>The Treatment of Mechanically Ventilated Adults with Early Activity and Mobilisation (TEAM) trial reported a higher occurrence of adverse events with greater mobilisation. However, their timing and nature remained unexplored. We conducted an in-depth exploration of such events.</p><p><strong>Objective: </strong>The purpose of this paper is to thoroughly examine the timing and characteristics of adverse events reported within the TEAM trial.</p><p><strong>Methods: </strong>Adverse event data were collected daily in real time. Categorical data were compared using the Fisher's exact test. The relationship between adverse events and patient survival was analysed using a Cox-regression frailty model.</p><p><strong>Results: </strong>Overall, 37 out of 371 patients (10.0%) in the early mobilisation group and 16 out of 370 patients (4.3%) in the usual care group experienced adverse events, with 71 events in the early mobilisation group compared to 24 events in the usual care group. The most common adverse events were altered blood pressure in 21 out of 53 patients (39.6%), arrhythmia in 17 out of 53 patients (32.1%), and oxygen desaturation in nine of 53 patients (17.0%). Patients with an adverse event were more likely to have congestive heart failure (absolute percentage difference: 16.1, 95% confidence interval [CI]: 6.1 to 26.1), peripheral vascular disease (absolute percentage difference: 6.4, 95% CI: 1.3 to 11.5), heart attack (absolute percentage difference: 13.5, 95% CI: 5.9 to 21.1), or stroke (absolute percentage difference: 9.3, 95% CI: 3.5 to 15.1). Adverse events occurred at a median of 4 days with early mobilisation and 7 days with usual care. There was no significant difference in survival for patients who experienced an adverse event compared to those without an adverse event.</p><p><strong>Conclusion: </strong>Adverse events were more common in patients randomised to early active mobilisation, were cardiovascular and respiratory in nature, tended to occur earlier with active mobilisation, and cardiovascular comorbidities were more common in such patients. This information can help guide future studies in this field.</p><p><strong>Trial registration: </strong>TEAM ClinicalTrials.gov number, NCT03133377, registered 28 April 2017.</p>\",\"PeriodicalId\":51239,\"journal\":{\"name\":\"Australian Critical Care\",\"volume\":\"38 3\",\"pages\":\"101156\"},\"PeriodicalIF\":2.6000,\"publicationDate\":\"2025-01-17\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Australian Critical Care\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1016/j.aucc.2024.101156\",\"RegionNum\":3,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q2\",\"JCRName\":\"CRITICAL CARE MEDICINE\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Australian Critical Care","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1016/j.aucc.2024.101156","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"CRITICAL CARE MEDICINE","Score":null,"Total":0}
Adverse events during and after early mobilisation: A post hoc analysis of the TEAM trial.
Background: The Treatment of Mechanically Ventilated Adults with Early Activity and Mobilisation (TEAM) trial reported a higher occurrence of adverse events with greater mobilisation. However, their timing and nature remained unexplored. We conducted an in-depth exploration of such events.
Objective: The purpose of this paper is to thoroughly examine the timing and characteristics of adverse events reported within the TEAM trial.
Methods: Adverse event data were collected daily in real time. Categorical data were compared using the Fisher's exact test. The relationship between adverse events and patient survival was analysed using a Cox-regression frailty model.
Results: Overall, 37 out of 371 patients (10.0%) in the early mobilisation group and 16 out of 370 patients (4.3%) in the usual care group experienced adverse events, with 71 events in the early mobilisation group compared to 24 events in the usual care group. The most common adverse events were altered blood pressure in 21 out of 53 patients (39.6%), arrhythmia in 17 out of 53 patients (32.1%), and oxygen desaturation in nine of 53 patients (17.0%). Patients with an adverse event were more likely to have congestive heart failure (absolute percentage difference: 16.1, 95% confidence interval [CI]: 6.1 to 26.1), peripheral vascular disease (absolute percentage difference: 6.4, 95% CI: 1.3 to 11.5), heart attack (absolute percentage difference: 13.5, 95% CI: 5.9 to 21.1), or stroke (absolute percentage difference: 9.3, 95% CI: 3.5 to 15.1). Adverse events occurred at a median of 4 days with early mobilisation and 7 days with usual care. There was no significant difference in survival for patients who experienced an adverse event compared to those without an adverse event.
Conclusion: Adverse events were more common in patients randomised to early active mobilisation, were cardiovascular and respiratory in nature, tended to occur earlier with active mobilisation, and cardiovascular comorbidities were more common in such patients. This information can help guide future studies in this field.
Trial registration: TEAM ClinicalTrials.gov number, NCT03133377, registered 28 April 2017.
期刊介绍：
Australian Critical Care is the official journal of the Australian College of Critical Care Nurses (ACCCN). It is a bi-monthly peer-reviewed journal, providing clinically relevant research, reviews and articles of interest to the critical care community. Australian Critical Care publishes peer-reviewed scholarly papers that report research findings, research-based reviews, discussion papers and commentaries which are of interest to an international readership of critical care practitioners, educators, administrators and researchers. Interprofessional articles are welcomed.
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