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临床试验/CTRI/2025/08/093257
CTRI/2025/08/093257尚未招募不适用

Incidence and Predictors of Post Intubation Cardiac Instability in Patients with Physiologically Difficult Airway in Emergency Department: A Prospective Cohort Study.

AIIMS BHOPAL1 个研究点 分布在 1 个国家目标入组 550 人开始时间: 2025年9月15日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
AIIMS BHOPAL
入组人数
550
试验地点
1
主要终点
Incidence of Peri-intubation Cardiac Instability (PICI) within 30 minutes of intubation

研究概览

简要总结

This
prospective observational cohort study aims to investigate the incidence and
determinants of post-intubation cardiac instability (PICI) among emergency
department (ED) patients with physiologically difficult airways (PDA),
defined by profound physiological disturbances including severe hypoxemia,
hypotension, metabolic acidosis, or shock states. Emergency intubation in
such patients, is associated with a heightened risk of peri-intubation
cardiovascular collapse and adverse outcomes. Despite this, current airway
guidelines focus largely on anatomical difficulty, neglecting the profound
physiological derangements that more strongly predict morbidity and
mortality.

Existing literature indicates that post-intubation hypotension and cardiac arrest are not uncommon in critically ill patients, with an estimated incidence of cardiovascular instability ranging from 30% to 45%. Russotto et al.’s INTUBE study, involving nearly 3,000 ICU patients, reported a 43.4% incidence of peri-intubation cardiovascular collapse. Similar findings were observed in ED settings, where the presence of shock, hypoxemia, or acidosis was strongly linked to poor outcomes. Emerging tools such as the Difficult Airway Physiological Score (DAPS) further underscore the prognostic importance of physiological parameters over anatomical markers.

The primary objective of this study is to quantify the incidence of PICI in ED patients meeting PDA criteria. Secondary objectives include identifying independent physiologic predictors of PICI, comparing the effects of different induction agents (e.g., ketamine vs etomidate), evaluating the influence of first-pass success and pre-intubation vasopressor use, and developing a preliminary risk stratification tool. Additionally, the study will assess the impact of post-intubation hemodynamic management on short-term outcomes, including 24-hour mortality.

The study will enroll at least 550 adult ED patients requiring intubation and exhibiting PDA features (hypotension, hypoxemia, or acidosis). Patients intubated outside the ED, those in pre-intubation cardiac arrest, or those re-intubated within 24 hours will be excluded. The primary outcome is the incidence of PICI, defined by standardized criteria including sustained hypotension, new or increase in vasopressor requirement, or cardiac arrest within 30 minutes of intubation. Secondary outcomes include ICU/hospital length of stay and mortality at 24 hours, 7 days, and 28 days.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • Patients with physiological difficult airway undergoing tracheal intubation in emergency department.

排除标准

  • Cardiac arrest prior to intubation
  • Intubation outside ED
  • Patients requiring re-intubation within 24 hours.

结局指标

主要结局

Incidence of Peri-intubation Cardiac Instability (PICI) within 30 minutes of intubation

时间窗: Incidence of Peri-intubation Cardiac Instability (PICI) within 30 minutes of intubation

次要结局

  • 1. 24-hour, 7-day, and 28-day mortality;(2. ICU and hospital length of stay)

研究者

发起方
AIIMS BHOPAL
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

SAURABH TRIVEDI

AIIMS BHOPAL

研究点 (1)

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