Prone Positioning in COVID-19 Patients
2022年1月31日 更新者：Kazim Rollas、Tepecik Training and Research Hospital
The Effect of Prone Positioning on Oxygenation and Respiratory Mechanics in Patients With COVID-19 Pneumonia
Prone positioning improves oxygenation in patients with ARDS (1-3). Patients with severe ARDS due to COVID-19 are candidates for prone position. It should be started within 36-48 h and maintained 1, 3). Prone ventilationARDS based on a randomized trial that showed a mortality benefit (PROSEVA) (3).
The improvement of oxygenation occurs by making ventilation more homogeneous, limiting ventilator-associated lung injury (4-6).
Prone positioning was as effective in improving oxygenation, static respiratory system compliance (Crs) (7).
Higher PEEP should be applied when there is a high recruitability potential of the lung. This study aimed to investigate whether prone positioning changes the recruitability position of the lung.in COVID-ARDS.
研究概览
详细说明
Prone positioning improves oxygenation in patients with ARDS (1-3). Patients with severe ARDS due to COVID-19 are candidates for prone position. It should be started within 36-48 h and maintained 1, 3). Prone ventilationARDS based on a randomized trial that showed a mortality benefit (PROSEVA) (3).
The improvement of oxygenation occurs by making ventilation more homogeneous, limiting ventilator-associated lung injury (4-6).
Prone positioning was as effective in improving oxygenation, static respiratory system compliance (Crs) (7).Higher PEEP should be applied when there is a high recruitability potential of the lung. This study aimed to investigate whether prone positioning changes the oxygenation, respiratory mechanics and recruitability position of the lung in COVID-ARDS.
研究类型
介入性
注册 (预期的)
50
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：KAZIM ROLLAS
- 电话号码：+905532787535
- 邮箱：kazim.rollas@yahoo.com
研究联系人备份
- 姓名：ÖMER EMGİN
- 电话号码：+905532787535
- 邮箱：ömer.emgin@yahoo.com
学习地点
-
-
-
İzmir、火鸡、55327
- 招聘中
- Kazim Rollas
-
接触：
- KAZIM ROLLAS
- 电话号码：+905532787535
- 邮箱：kazim.rollas@yahoo.com
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Adult patients with laboratory-confirmed COVID-19 admitted to the ICU
- The patients receive invasive mechanical ventilation and meet the criteria for ARDS (Berlin definition) (8), with under continuous infusion of sedatives,
Exclusion Criteria:
- Pregnancy
- Pneumothorax and or chest tube
- Chronic obstructive lung disease
- interstitial lung disease
- intraabdominal hypertension
- increase in intracranial blood pressure
- Haemodynamic unstability requiring vasopressors
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：放映
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
其他：Prone Positioning
Patients will be ventilated in volume-controlled mode with Vt at 6 ml/kg of predicted body weight.
Prone positioning will be performed over periods of 16 hours when PaO2/FiO2 was persistently lower than 150 mm Hg.
Flow, volume, and airway pressure will bw measured by ventilators.
Measurements of oxygenation and respiratory mechanics were performed at 5 and 15 cmH20 PEEP levels and will be repeated every season as before first period of prone positioning, before supine positioning, and again before second period of prone positioning.
Total PEEP and plateau pressure will be measured by a short end-expiratory and an end-inspiratory occlusion respectively.
Complete airway closure will be assessed by performing a low-flow (4 L/min) inflation( PV tool) (9).
The potential for lung recruitment will be assessed by means of the R/I ratio (10).
|
Oxygenation will be calculated as PaO2/ FiO2 ratio.Static compliance will be calculated as tidal volume divided driving pressure.The potential for lung recruitment will be assessed by means of the R/I ratio (10).
其他名称：
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Oxygenation
大体时间：intubation + 48 hours
|
PaO2/FiO2
|
intubation + 48 hours
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Static compliance
大体时间：intubation + 48 hours
|
Tidal volume divided driving pressure
|
intubation + 48 hours
|
|
Recruitability
大体时间：intubation + 48 hours
|
recruitment to inflation ratio
|
intubation + 48 hours
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 学习椅：Işıl Köse Güldoğan、İzmi̇r Tepeci̇k Eği̇ti̇m Ve Arştırma Hastanesi̇
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Guerin C, Reignier J, Richard JC, Beuret P, Gacouin A, Boulain T, Mercier E, Badet M, Mercat A, Baudin O, Clavel M, Chatellier D, Jaber S, Rosselli S, Mancebo J, Sirodot M, Hilbert G, Bengler C, Richecoeur J, Gainnier M, Bayle F, Bourdin G, Leray V, Girard R, Baboi L, Ayzac L; PROSEVA Study Group. Prone positioning in severe acute respiratory distress syndrome. N Engl J Med. 2013 Jun 6;368(23):2159-68. doi: 10.1056/NEJMoa1214103. Epub 2013 May 20.
- Chen L, Del Sorbo L, Grieco DL, Junhasavasdikul D, Rittayamai N, Soliman I, Sklar MC, Rauseo M, Ferguson ND, Fan E, Richard JM, Brochard L. Potential for Lung Recruitment Estimated by the Recruitment-to-Inflation Ratio in Acute Respiratory Distress Syndrome. A Clinical Trial. Am J Respir Crit Care Med. 2020 Jan 15;201(2):178-187. doi: 10.1164/rccm.201902-0334OC.
- Chen L, Del Sorbo L, Grieco DL, Shklar O, Junhasavasdikul D, Telias I, Fan E, Brochard L. Airway Closure in Acute Respiratory Distress Syndrome: An Underestimated and Misinterpreted Phenomenon. Am J Respir Crit Care Med. 2018 Jan 1;197(1):132-136. doi: 10.1164/rccm.201702-0388LE. No abstract available.
- ARDS Definition Task Force; Ranieri VM, Rubenfeld GD, Thompson BT, Ferguson ND, Caldwell E, Fan E, Camporota L, Slutsky AS. Acute respiratory distress syndrome: the Berlin Definition. JAMA. 2012 Jun 20;307(23):2526-33. doi: 10.1001/jama.2012.5669.
- Mancebo J, Fernandez R, Blanch L, Rialp G, Gordo F, Ferrer M, Rodriguez F, Garro P, Ricart P, Vallverdu I, Gich I, Castano J, Saura P, Dominguez G, Bonet A, Albert RK. A multicenter trial of prolonged prone ventilation in severe acute respiratory distress syndrome. Am J Respir Crit Care Med. 2006 Jun 1;173(11):1233-9. doi: 10.1164/rccm.200503-353OC. Epub 2006 Mar 23.
- Guerin C, Gaillard S, Lemasson S, Ayzac L, Girard R, Beuret P, Palmier B, Le QV, Sirodot M, Rosselli S, Cadiergue V, Sainty JM, Barbe P, Combourieu E, Debatty D, Rouffineau J, Ezingeard E, Millet O, Guelon D, Rodriguez L, Martin O, Renault A, Sibille JP, Kaidomar M. Effects of systematic prone positioning in hypoxemic acute respiratory failure: a randomized controlled trial. JAMA. 2004 Nov 17;292(19):2379-87. doi: 10.1001/jama.292.19.2379.
- Lai-Fook SJ, Rodarte JR. Pleural pressure distribution and its relationship to lung volume and interstitial pressure. J Appl Physiol (1985). 1991 Mar;70(3):967-78. doi: 10.1152/jappl.1991.70.3.967.
- Cornejo RA, Diaz JC, Tobar EA, Bruhn AR, Ramos CA, Gonzalez RA, Repetto CA, Romero CM, Galvez LR, Llanos O, Arellano DH, Neira WR, Diaz GA, Zamorano AJ, Pereira GL. Effects of prone positioning on lung protection in patients with acute respiratory distress syndrome. Am J Respir Crit Care Med. 2013 Aug 15;188(4):440-8. doi: 10.1164/rccm.201207-1279OC.
- Douglas WW, Rehder K, Beynen FM, Sessler AD, Marsh HM. Improved oxygenation in patients with acute respiratory failure: the prone position. Am Rev Respir Dis. 1977 Apr;115(4):559-66. doi: 10.1164/arrd.1977.115.4.559.
- Park J, Lee HY, Lee J, Lee SM. Effect of prone positioning on oxygenation and static respiratory system compliance in COVID-19 ARDS vs. non-COVID ARDS. Respir Res. 2021 Aug 6;22(1):220. doi: 10.1186/s12931-021-01819-4.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2021年12月25日
初级完成 (实际的)
2022年2月1日
研究完成 (预期的)
2022年4月13日
研究注册日期
首次提交
2021年12月7日
首先提交符合 QC 标准的
2021年12月7日
首次发布 (实际的)
2021年12月9日
研究记录更新
最后更新发布 (实际的)
2022年2月1日
上次提交的符合 QC 标准的更新
2022年1月31日
最后验证
2022年1月1日
更多信息
与本研究相关的术语
其他研究编号
- 2021/11-02
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
是的
IPD 计划说明
Will be shared as the first patient included in the study
IPD 共享时间框架
From 25 december - 3 months
IPD 共享支持信息类型
- 研究方案
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
2019冠状病毒病的临床试验
-
Leidos Life SciencesUnited States Department of Defense主动，不招人新冠肺炎 | 新冠肺炎 | 2019冠状病毒病 | SARS-CoV-2 感染 | SARS-CoV-2 急性呼吸道疾病 | 2019冠状病毒病大流行 | COVID-19 病毒感染 | COVID-19 病毒病 | 2019新型冠状病毒病 | 2019新型冠状病毒感染 | 2019-nCoV 疾病 | 2019-nCoV 感染美国
-
Leidos Life SciencesUnited States Department of Defense撤销新冠肺炎 | 新冠肺炎 | 2019冠状病毒病 | SARS-CoV-2 感染 | SARS-CoV-2 急性呼吸道疾病 | 2019冠状病毒病大流行 | COVID-19 病毒感染 | COVID-19 病毒病 | 2019新型冠状病毒病 | 2019新型冠状病毒感染 | 2019-nCoV 疾病 | 2019-nCoV 感染
-
Leidos Life SciencesUnited States Department of Defense终止新冠肺炎 | 新冠肺炎 | 2019冠状病毒病 | SARS-CoV2 感染 | SARS-CoV-2 急性呼吸道疾病 | 2019冠状病毒病大流行 | COVID-19 病毒感染 | COVID-19 病毒病 | 2019新型冠状病毒病 | 2019新型冠状病毒感染 | 2019-nCoV 疾病 | 2019-nCoV 感染美国
-
AudibleHealth AI, Inc.Sunrise Research Institute; Analytical Solutions Group, Inc.; Kelley Medical Consultants LLC; R....完全的2019冠状病毒病 | SARS-CoV-2 感染 | 2019冠状病毒病大流行 | COVID-19 病毒感染 | 冠状病毒病 19 | COVID-19 病毒病 | 2019新型冠状病毒病 | 2019新型冠状病毒感染 | 2019-nCoV 疾病美国
-
EyeGene Inc.Novotech (Australia) Pty Limited主动，不招人
-
Hannover Medical SchoolUniversitätsklinikum Hamburg-Eppendorf; German Center for Infection Research; IDT Biologika终止
-
Hospices Civils de Lyon完全的血液透析并发症 | 2019冠状病毒病疫苗法国
-
Beijing Children's HospitalThe First Affiliated Hospital of Anhui Medical University; Shengjing Hospital; China-Japan Friendship... 和其他合作者未知