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临床试验/NCT05412823
NCT05412823招募中不适用

Post Intubation Neurologic Outcomes in Critically Ill Adults

King Abdulaziz University1 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2022年7月22日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
1,000
试验地点
1
主要终点
Modified Rankin Scale (mRs)

研究概览

简要总结

The frequency of oxygen desaturation during emergency intubation is not uncommon. However, the significance and clinical sequalae of hypoxia during emergency intubation in critically ill, non-trauma patients is not known. Therefore, the aim of this study is to evaluate neurologic function post-intubation of critically ill, non-trauma patients. Providing knowledge on whether the degree of hypoxia during emergency intubation is associated with worse neurologic outcomes, will guide clinical practice to ameliorate that level of hypoxia

详细描述

Critically ill patients undergoing emergent endotracheal intubation are at risk for oxygen desaturation in a variety of acute care settings. Such complication could arise from patient, operator, or procedure related factors. Evidence suggests that rapid sequence intubation (RSI) improves first-pass success and reduces complications in the critically ill. Nonetheless, the procedure is not without risks. In fact, emergency intubation is associated a reported oxygen desaturation rate of 10.9% - 33.5%. High quality pre-oxygenation has been shown to prolong time to desaturation during emergency airway management. Despite advances preoxygenation techniques, a significant number of patients undergoing emergency intubation still experience desaturation. Most of the time this is transient and easily reversible. Occasionally however, desaturation becomes critical and may result in devastating complications such as dysrhythmias or cardiopulmonary arrest.

The brain consumes a significant amount of energy and is exquisitely sensitive to hypoxia and hypoperfusion. Hypoxic brain injury occurs whenever oxygen delivery to the brain is compromised. The role of secondary brain insults including hypoxia and hypotension, in traumatic brain injury (TBI) is well established. Previous literature has demonstrated that a single event of hypoxemia in a head-injured patient substantially increases morbidity and mortality. This has resulted in airway management being a cornerstone in the care of unconscious TBI patients, to ensure adequate oxygen delivery to the injured brain. However, the significance and clinical sequalae of hypoxia during emergency intubation in critically ill, non-trauma patients is not known. Therefore, the aim of this study is to evaluate neurologic function post-intubation of critically ill, non-trauma patients.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Good baseline neurologic function (Modified Rankin Scale: 1-3)
  • Emergency departments
  • Critical care units
  • In-patient floors
  • Patients undergoing emergent intubations as determined by the treating physician
  • Age> 17 years old
  • Good baseline modified rankin scale (mRs 1-3)

排除标准

  • Pediatric patients (17 years of age of less)
  • Pregnant patients
  • Intubations occurring in the operating room
  • Prisoners
  • Status epilepticus
  • Primary intracranial pathology
  • Cardiopulmonary arrest
  • Poor baseline neurologic function (Modified Rankin Scale: 4-5)
  • Pre-Hospital Intubation

结局指标

主要结局

Modified Rankin Scale (mRs)

时间窗: Up to 30-days of intubation

A validated 6-point scale for measuring the degree of disability in the daily activities of people suffering neurological impairment. The scale runs from 0-6, in which "0" indicates perfect health without disability and "6" indicates the worst outcome which is death.

次要结局

  • In-hospital Mortality(Up to 30-days of intubation)
  • ICU Length of Stay(Up to 30-days from intubation)
  • Hospital Length of Stay(Up to 30-days of intubation)
  • Incidence of Aspiration(Up to 14-days of intubation)
  • Post-Intubation Complications(Within 24-hours)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. Abdullah Bakhsh

Assistant Professor of Emergency Medicine

King Abdulaziz University

研究点 (1)

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