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临床试验/NCT07049666
NCT07049666已完成不适用

Effects of Preoxygenation With Bag-valve-mask and Noninvasive Mechanical Ventilation on Oxygenation and Hemodynamics: A Randomized Controlled Study

Baskent University1 个研究点 分布在 1 个国家目标入组 128 人开始时间: 2022年12月26日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
128
试验地点
1
主要终点
Change in partial pressure of oxygen in arterial blood (PaO₂) values after 3 minutes of preoxygenation

研究概览

简要总结

Hypoxemia refers to low blood oxygen levels, while hypoxia denotes low tissue oxygen levels. Both conditions pose life-threatening risks when precautions are not adequately taken or when risks are not effectively managed. Intubation represents a critical phase that can lead to a decrease in arterial oxyhemoglobin levels. Two frequently employed techniques for preoxygenation and ventilation during intubation are bag-valve mask (BVM) ventilation and noninvasive mechanical ventilation (NIMV). The aim of this study was to evaluate the efficacy and safety of BMV and the NIMV.

详细描述

Ventilation and intubation challenges increase the risk of arterial desaturation, emphasizing the importance of careful management during this process. Throughout the intubation process, the oxygen reserves within the lung, plasma, hemoglobin, body mass index (BMI) play a critical role in meeting the tissue oxygen demand. Preoxygenation serves to extend the time window for intubation safely. The quantity of available oxygen reserve and the duration of the apneic period represent the primary determinants for the occurrence of hypoxemia during intubation.

Anticipating difficult intubation is crucial, as it often prolongs both the duration of intubation and the apneic period. The Intubation Difficulty Scale (IDS) is commonly utilized to predict the likelihood of encountering difficult intubation scenarios. It is imperative to select the appropriate preoxygenation technique, particularly in patients with a high IDS, to mitigate the risk of desaturation during the intubation process.

Two frequently employed techniques for preoxygenation and ventilation during intubation are BVM ventilation and NIMV. Preoxygenation, also referred to as denitrogenation, has the potential to induce atelectasis. However, this complication can be mitigated with positive pressure ventilation (PPV), which not only aids in maintaining oxygen levels but also exerts effects on the circulatory system. Hypotension is the most common symptom that occurs as a result of the interaction of the respiratory and circulatory systems.

The objective of this study was to evaluate and compare the impacts of preoxygenation with BVM and NIMV techniques on oxygenation and hemodynamic parameters specifically during the apneic period of endotracheal intubation.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

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

入选标准

  • •Aged over 18 years
  • •Having a partial arterial oxygen pressure (PaO2)/fraction of inspired oxygen (FiO2) ratio exceeding 200
  • •Consented to participate

排除标准

  • •Patients with an American Society of Anesthesiologists (ASA) Physical Status Classification System Score 4
  • •Patients with a Mallampati Score greater than 3
  • •Patients with a history of difficult intubation
  • •Patients who are pregnancy
  • •Patients who have hypoxia (defined as a PaO2/FiO2 ratio less than 200)
  • •Patients with heart failure
  • •Patients with chronic obstructive pulmonary disease
  • •Patients who undergoing emergency surgeries

研究组 & 干预措施

bag-valve mask ventilation

Experimental

Preoxygenation was administered utilizing a Compower (Fujian, China) BVM equipped with an oxygen reservoir, coupled with a correctly fitted oronasal mask. This preoxygenation procedure spanned three minutes, with an oxygen flow rate set at 15 liters per minute.

干预措施: Bag-valve mask (Device)

bag-valve mask ventilation

Experimental

Preoxygenation was administered utilizing a Compower (Fujian, China) BVM equipped with an oxygen reservoir, coupled with a correctly fitted oronasal mask. This preoxygenation procedure spanned three minutes, with an oxygen flow rate set at 15 liters per minute.

干预措施: Noninvasive mechanical ventilation (Device)

noninvasive mechanical ventilation

Active Comparator

Preoxygenation was conducted over a three-minute period using NIMV employing a properly fitted oronasal mask. This was facilitated by the Servo S (Maquet, Solna, Sweden) mechanical ventilator operating in pressure support mode. The preoxygenation protocol entailed the administration of 100% FiO2, applying Positive End-Expiratory Pressure (PEEP) set at 5 cmH2O, delivering breaths at a frequency of 15 per minute, and providing a tidal volume ranging between 6 to 8 ml/kg of body weight.

干预措施: Noninvasive mechanical ventilation (Device)

noninvasive mechanical ventilation

Active Comparator

Preoxygenation was conducted over a three-minute period using NIMV employing a properly fitted oronasal mask. This was facilitated by the Servo S (Maquet, Solna, Sweden) mechanical ventilator operating in pressure support mode. The preoxygenation protocol entailed the administration of 100% FiO2, applying Positive End-Expiratory Pressure (PEEP) set at 5 cmH2O, delivering breaths at a frequency of 15 per minute, and providing a tidal volume ranging between 6 to 8 ml/kg of body weight.

干预措施: Bag-valve mask (Device)

结局指标

主要结局

Change in partial pressure of oxygen in arterial blood (PaO₂) values after 3 minutes of preoxygenation

时间窗: At the end of 3 minutes of preoxygenation

To compare PaO₂ between study groups after 3 minutes of preoxygenation (Unit of Measure: mmHg)

Change in partial pressure of carbon dioxide in arterial blood (PaCO₂) values after 3 minutes of preoxygenation

时间窗: At the end of 3 minutes of preoxygenation

To compare PaCO₂ between study groups after 3 minutes of preoxygenation (Unit of Measure: mmHg)

次要结局

  • Change in systolic blood pressure(At the 5th minute after intubation)
  • Change in diastolic blood pressure(At the 5th minute after intubation)
  • Change in mean arterial pressure (MAP)(At the 5th minute after intubation)
  • Change in heart rate(At the 5th minute after intubation)
  • Change in peripheral oxygen saturation (SpO₂)(At the 5th minute after intubation)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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