Tracheal Intubation in COVID-19 Patients
2021年6月1日 更新者：Silvia De Rosa、St. Bortolo Hospital
Airways Management in COVID-19 Related Respiratory Failure: a Prospective Observational Multi-center Study
The Emergency Endotracheal intubation of a patient who is COVID-19 positive is a high-risk procedure and an additional challenge to an intensivist due to barrier enclosures that have been developed to reduce the risk of COVID-19 transmission to healthcare providers during intubation.
Although the incidence of difficult airways is commonly higher in critically ill patients, the evidence of severe hypoxemia without sign of respiratory distress could complicate the scenario.This silent hypoxia often leads to a delayed recognition of the severity of respiratory failure and to a late intubation which is often characterized by a high risk of complications related to the actual airways' management, hemodynamic and cardiac.
It has been shown that non-survivors had worse blood gas analyzes than survivors, both before and after intubation.
Few studies have reported the implications and adverse events of performing endotracheal intubation for critically ill COVID-19 patients admitted to intensive care units (ICUs).
研究概览
研究类型
观察性的
注册 (预期的)
143
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：Silvia De Rosa, MD
- 电话号码：+393933098583
- 邮箱：silvia.derosa@aulss8.veneto.it
学习地点
-
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Lombardia
-
Pavia、Lombardia、意大利、27100
- 招聘中
- San Matteo Hospital
-
接触：
- Silvia Mongodi, MD
- 电话号码：+393491217156
- 邮箱：S.Mongodi@smatteo.pv.it
-
-
Veneto
-
Vicenza、Veneto、意大利、36100
- 招聘中
- San Bortolo Hospital
-
接触：
- Silvia De Rosa, MD
- 电话号码：+39 3933098583
- 邮箱：silvia.derosa@aulss8.veneto.it
-
首席研究员：
- Silvia De Rosa, MD
-
首席研究员：
- Lucia Cattin, MD
-
-
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
取样方法
非概率样本
研究人群
Critically ill patient above 18 year old, admitted in the Intensive Care
描述
Inclusion Criteria:
- Critically ill patient above 18 year old, admitted in the Intensive Care of San Bortolo Hospital, Vicenza, and San Matteo Hospital, Pavia;
- positive specimen for SARS-COV2 PCR;
- tracheal intubation for respiratory distress related to SARS COV2 pneumonia
Exclusion Criteria:
- negative specimen for SARS-COV2 PCR
- out of hospital intubation
- intubation during cardiac arrest
- intubation in the contest of general anesthesia for surgery
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
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
|
Severe COVID pneumonia with ET
Severe COVID 19 pneumonia undergoing endotracheal intubation
|
Airways management in COVID 19 patients pneumonia
|
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 |
|---|---|---|
|
Major adverse peri-intubation events
大体时间：intubation procedure, an expected average 30 minutes
|
The incidence of major adverse peri-intubation events defined as least one events:
|
intubation procedure, an expected average 30 minutes
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Number of minor complications in the intubation process in patients admitted in the intensive care
大体时间：28 days
|
This study will analyze the prevalence of minor complications related to intubation technique in the the Critical Unit.
This information will be useful in order to determinate the risk factors associated.
|
28 days
|
|
Correlation between videolaryngoscope use and incidence of complication compared to the conventional laryngoscopy
大体时间：28 days
|
Although the video laryngoscope is useful to perform difficult airways management, the benefits associated to its employment is still controversial compared to the conventional laringoscope.
|
28 days
|
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
- 首席研究员：Lucia Cattin, MD、SBortolo Hospital
- 首席研究员：Silvia De Rosa, MD、SBortolo Hospital
- 首席研究员：Silvia Mongodi, MD、SMatteo Hospital
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
- Goh KJ, Choong MC, Cheong EH, Kalimuddin S, Duu Wen S, Phua GC, Chan KS, Haja Mohideen S. Rapid Progression to Acute Respiratory Distress Syndrome: Review of Current Understanding of Critical Illness from Coronavirus Disease 2019 (COVID-19) Infection. Ann Acad Med Singap. 2020 Mar 16;49(3):108-118.
- Yao W, Wang T, Jiang B, Gao F, Wang L, Zheng H, Xiao W, Yao S, Mei W, Chen X, Luo A, Sun L, Cook T, Behringer E, Huitink JM, Wong DT, Lane-Fall M, McNarry AF, McGuire B, Higgs A, Shah A, Patel A, Zuo M, Ma W, Xue Z, Zhang LM, Li W, Wang Y, Hagberg C, O'Sullivan EP, Fleisher LA, Wei H; collaborators. Emergency tracheal intubation in 202 patients with COVID-19 in Wuhan, China: lessons learnt and international expert recommendations. Br J Anaesth. 2020 Jul;125(1):e28-e37. doi: 10.1016/j.bja.2020.03.026. Epub 2020 Apr 10.
- Carrillo A, Gonzalez-Diaz G, Ferrer M, Martinez-Quintana ME, Lopez-Martinez A, Llamas N, Alcazar M, Torres A. Non-invasive ventilation in community-acquired pneumonia and severe acute respiratory failure. Intensive Care Med. 2012 Mar;38(3):458-66. doi: 10.1007/s00134-012-2475-6. Epub 2012 Feb 9.
- Martin LD, Mhyre JM, Shanks AM, Tremper KK, Kheterpal S. 3,423 emergency tracheal intubations at a university hospital: airway outcomes and complications. Anesthesiology. 2011 Jan;114(1):42-8. doi: 10.1097/ALN.0b013e318201c415.
- Huang HB, Peng JM, Weng L, Liu GY, Du B. High-flow oxygen therapy in immunocompromised patients with acute respiratory failure: A review and meta-analysis. J Crit Care. 2018 Feb;43:300-305. doi: 10.1016/j.jcrc.2017.09.176. Epub 2017 Sep 22.
- Cattin L, Ferrari F, Mongodi S, Pariani E, Bettini G, Daverio F, Donadello K, Polati E, Mojoli F, Danzi V, De Rosa S. Airways management in SARS-COV-2 acute respiratory failure: A prospective observational multi-center study. Med Intensiva (Engl Ed). 2022 Aug 8:S2173-5727(22)00206-5. doi: 10.1016/j.medine.2022.08.005. Online ahead of print.
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)
2020年11月17日
初级完成 (实际的)
2021年5月20日
研究完成 (预期的)
2021年6月10日
研究注册日期
首次提交
2021年5月28日
首先提交符合 QC 标准的
2021年5月28日
首次发布 (实际的)
2021年6月1日
研究记录更新
最后更新发布 (实际的)
2021年6月4日
上次提交的符合 QC 标准的更新
2021年6月1日
最后验证
2021年6月1日
更多信息
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.