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INTUPROS 2-3: Improving First-Pass Intubation Success and Reducing Complications in ICU Patients (INTUPROS)

National Program to Improve First-Pass Intubation Success and Reduce Major Complications During Tracheal Intubation in Intensive Care Units: A Quasi- Experimental Study Following an Educational Intervention (INTUPROS 2 and 3)

This national, multicenter, prospective cohort study aims to determine the prevalence and risk factors associated with major peri-intubation complications in critically ill adult patients undergoing tracheal intubation in intensive care units (ICUs), and to compare these findings with those previously reported in the INTUPROS 1 study. Additionally, the study will evaluate the impact of a structured educational intervention on airway management practices and clinical outcomes through a pre- and post-intervention design

研究概览

地位

尚未招聘

详细说明

Tracheal intubation in critically ill patients admitted to intensive care units (ICUs) is associated with a high risk of severe complications, including cardiovascular instability, severe hypoxemia, cardiac arrest, and death. Previous multicenter studies, including the INTUPROS 1 study, have reported major peri-intubation complication rates of approximately 40-45%, emphasizing the need for improved airway management strategies. Despite advances in airway devices and monitoring techniques, first-pass intubation success rates and complication rates have not significantly improved over time. Variability in clinical practice, differences in operator experience, and inconsistent use of standardized protocols may contribute to these outcomes. The INTUPROS 2-3 study is a national, multicenter, prospective cohort study designed to evaluate current airway management practices and their associated outcomes in ICU patients, as well as to assess the effect of a structured educational intervention.

The study is conducted in three sequential phases:

INTUPROS 2 (pre-intervention phase): prospective observational data collection to determine the prevalence and risk factors of major peri-intubation complications, and to compare these results with those previously reported in INTUPROS 1. Educational intervention phase: implementation of a structured training program including simulation-based airway management training, dissemination of standardized protocols, promotion of videolaryngoscopy and capnography use, and distribution of educational materials. INTUPROS 3 (post-intervention phase): prospective observational data collection using the same methodology as in the pre-intervention phase to evaluate changes in airway management practices and clinical outcomes following the intervention. The primary objective is to determine the prevalence and identify risk factors associated with major peri-intubation complications within 30 minutes of the procedure. Major complications are defined as a composite endpoint including cardiovascular instability, severe hypoxemia, cardiac arrest requiring resuscitation, or death. Secondary objectives include evaluating first-pass intubation success, incidence of hemodynamic instability, use of airway devices such as videolaryngoscopy, pharmacological strategies used during intubation, number of intubation attempts, and adherence to recommended airway management practices. This quasi-experimental, before-and-after design allows both epidemiological characterization of current practices and assessment of the real-world impact of a national educational quality improvement program.

研究类型

观察性的

注册 (估计的)

1300

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

研究联系人备份

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

  • 成人
  • 年长者

接受健康志愿者

不

取样方法

非概率样本

研究人群

Patients intubated in the ICU

描述

Inclusion Criteria:

  • Patients undergoing tracheal intubation in ICU

Exclusion Criteria:

  • Intubation outside ICU
  • Cardiac arrest at time of intubation

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

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 peri-intubation complications
大体时间:Within 30 minutes from the start of the tracheal intubation procedure.
Number and proportion of patients experiencing at least one major peri-intubation complication during tracheal intubation in the intensive care unit. Major peri-intubation complications include cardiovascular instability, severe hypoxemia, cardiac arrest requiring resuscitation, and death. Risk factors independently associated with major peri-intubation complications will also be analyzed, and the results will be compared with those previously reported in the INTUPROS 1 study.
Within 30 minutes from the start of the tracheal intubation procedure.

次要结果测量

结果测量
措施说明
大体时间
First-pass intubation success
大体时间:During the tracheal intubation procedure, at the first intubation attempt.
Number and proportion of patients in whom successful tracheal intubation is achieved on the first intubation attempt. The first-pass intubation success rate will be compared with that previously reported in the INTUPROS 1 study.
During the tracheal intubation procedure, at the first intubation attempt.
Use of videolaryngoscopy and type of videolaryngoscope
大体时间:During the tracheal intubation procedure.
Number and proportion of tracheal intubations in which videolaryngoscopy is used. The type of videolaryngoscope used and its order of use during the intubation procedure will also be recorded.
During the tracheal intubation procedure.
Pharmacological agents used to facilitate tracheal intubation
大体时间:During the tracheal intubation procedure.
Number and proportion of patients receiving each pharmacological agent used to facilitate tracheal intubation. The agents used and their doses will be recorded, and patterns of pharmacological agent use will be compared with those previously reported in the INTUPROS 1 study.
During the tracheal intubation procedure.
Predictive performance of the INTUPROS difficult airway prediction score
大体时间:During the tracheal intubation procedure.
Predictive performance for difficult tracheal intubation of the difficult airway prediction score derived from the INTUPROS 1 database. The prediction score does not include the MACOCHA score.
During the tracheal intubation procedure.

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:Jose Garmacho- Montero, MD, PhD、Hospital Universitario Virgen del Rocio, Sevilla
  • 首席研究员:Federico Gordo-Vidal, MD, PhD、Hospital Universitario del Henares
  • 首席研究员:Jose Luis Garcia - Garmendia, MD, PhD、Hospital San Juan de Dios del Aljarafe

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 (估计的)

2027年3月1日

初级完成 (估计的)

2027年11月1日

研究完成 (估计的)

2028年5月1日

研究注册日期

首次提交

2026年8月24日

首先提交符合 QC 标准的

2026年9月2日

首次发布 (实际的)

2026年9月8日

研究记录更新

最后更新发布 (实际的)

2026年9月8日

上次提交的符合 QC 标准的更新

2026年9月2日

最后验证

2026年8月1日

更多信息

与本研究相关的术语

关键字

其他研究编号

  • Intupros2-3

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

未定

IPD 计划说明

The sharing of de-identified individual participant data has not yet been determined and will be considered upon study completion, taking into account ethical, legal, and data protection requirements.

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.

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