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临床试验/NCT03600181
NCT03600181已完成不适用

Non-invasive Technology for Early Signal Detection of Hypoxemia With ORI During Intubation

Nantes University Hospital1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2019年2月11日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
50
试验地点
1
主要终点
Assess whether the ORI index allows earlier detection of hypoxemia than with SpO2

研究概览

简要总结

Intubation of patients in the intensive care unit (ICU) carries a risk of potentially severe complications, including cardiac arrest. Hypoxemia is common in ICU patients requiring intubation, which must be performed rapidly to avoid aspiration, since the patient is usually not in the fasted state. Studies have assessed interventions designed to improve intubation success rates, such as routine neuromuscular blockade. Care bundles combined with training on simulators have improved the safety of intubation. Nevertheless, intubation in the ICU still carries higher morbidity and mortality rates compared to intubation in the operating room.

Preoxygenation is a cornerstone of safety for intubation in the ICU. Several recent trials have investigated different devices (non-rebreather mask, non-invasive ventilation, high flow nasal cannula, bag valve mask) with conflicting results. A main reason for those results is that efficiency of the preoxygenation period cannot be evaluated in the ICU in opposite to the operating room: gas monitoring are not available in ICU and even if it was the case, high flow demand from the patient, and agitation will make it inefficient. Additionally, desaturation is frequent (from 10% up to 50%) during intubation in ICU and lead to morbidity and mortality; so anticipation of desaturation is a major concern for ICU's physician because it's impacting care (face mask ventilation, early insertion of subglottic device). The oxygen reserve index (ORI) is a new parameter for monitoring oxygen reserve non-invasively.

In this context, the investigators purpose to analyze efficiency of preoxygenation and time allowed by ORI for medical interventions before hypoxemia during intubation in the ICU in a pilot observational study in our medical ICU in a university hospital.

详细描述

*Severe hypoxaemia is the most common serious adverse event during endotracheal intubation (ETI) in patients admitted to the intensive care unit (ICU), consistently reported around 25%. Preoxygenation is universally recommended as a risk-minimisation measure. While effective in the operating room, preoxygenation is more complex in critically ill patients, most notably those with acute hypoxic respiratory failure, as the low functional residual capacity (FRC) carries a risk of denitrogenation being confined to the healthy lung parenchyma, so that the FeO2 (Fraction of expired oxygen) no longer reflects the partial pressure of oxygen in arterial blood (PaO2). In these patients, 8 minutes of preoxygenation using a bag-valve-mask (BVM) device failed to change PaO2 levels noticeably. Increasing the BVM time was unhelpful, as the increase in PaO2 achieved in some patients was offset by decreases in others.

Non-invasive ventilation (NIV) has theoretical advantages for preoxygenation and has been shown to provide higher PaO2 values in hypoxic patients compared to a non-rebreathing (NRB) mask. However, use of NIV has several contraindications including consciousness alterations and agitation, and drawbacks such as gastric distension.

Apnoeic oxygenation which has been updated is a method consisting in continued oxygenation during laryngoscopy to extend the safe apnoea time. High-flow nasal oxygen (HFNO) therapy ensuring high and stable FiO2 (fraction of inspired oxygen) values by delivering oxygen flows above 60 L/min is another innovation shown to improve oxygenation in hypoxaemic patients. The effect of HFNO for preoxygenation, however, is less clear, as one study suggested benefits vs. NRB mask in patients with moderate hypoxaemia but another found no significant difference vs. BVM in patients with PaO2/FiO2 ratios below 200. No large randomised trial has compared preoxygenation methods. The latest recommendations of the Difficult Airway Society suggest than "In hypoxaemic patients, CPAP (continuous positive airway pressure) and non-invasive ventilation (NIV) may be beneficial."

As preoxygenation is a cornerstone of safety for intubation in the ICU, several recent trials have investigated different devices (non-rebreather mask, non-invasive ventilation, high flow nasal cannula, bag valve mask) with conflicting results. A main reason for those results is that efficiency of the preoxygenation period cannot be evaluated in the ICU in opposite to the operating room : gas monitoring are not available in ICU and even if it was the case, high flow demand from the patient, and agitation will make it inefficient. Additionally, desaturation is frequent (from 10% up to 50%) during intubation in ICU and lead to morbidity and mortality; so anticipation of desaturation is a major concern for ICU's physician because it's impacting care (face mask ventilation, early insertion of subglottic device).

The oxygen reserve index (ORI) (Masimo Corp., Irvine, CA, USA) is a new parameter that indicates real-time oxygenation reserve status in mild hyperoxemia range [partial pressure of oxygen (PaO2) of about 100-200 mmHg). ORI can be measured non-invasively by applying an exclusive sensor on a finger; the ORI is a nondimensional index that changes according to the oxygenation reserve status of the patient. It uses a value range of 0.00-1.00.

研究设计

研究类型
Observational
观察模型
Other
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

  • ICU admission and need for orotracheal intubation (OTI) to allow mechanical ventilation.
  • SpO2/FiO2 ratio upper than 214 (the SpO2/FiO2 ratio will be measured under NIV or HFNC(high flow nasal cannula), and calculated under standard oxygen as follows : FiO2 = 0.21+oxygen flow rate×0.03).

排除标准

  • Patients will be excluded from the analysis if :
  • Failure of computer used to record ORI.
  • No ORI values displayed.
  • ORI remaining constant at 1 throughout the monitoring.
  • SpO2 will stay under 97% during intubation process.

结局指标

主要结局

Assess whether the ORI index allows earlier detection of hypoxemia than with SpO2

时间窗: Participants will be followed for the duration of intubation process, an expected average of 10 minutes.

Average delay between drop of ORI and drop of SpO2 will be estimate with 95% confidence interval

次要结局

  • Measuring prognosis value of ORI during preoxygenation for occurrence of hypoxemia during intubation process(Participants will be followed for the duration of intubation process, an expected average of 10 minutes.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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