Preoxygenation for Tracheal Aspirations in Intensive Care, a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 2,260
- 试验地点
- 2
- 主要终点
- Rate of suctioning leading to deep desaturation
研究概览
简要总结
Clearing the airways is a complex phenomenon involving the production of secretions, the nature of mucus (viscosity, elasticity, stringiness, and adhesiveness), ciliary movement, and coughing. In intubated and ventilated patients, endotracheal suctioning occur when the patient is "unable to clear the airways of obstructions hindering the free passage of air." These suctioning can lead to transient desaturation exacerbated by a decrease in cardiac output due to increased mean arterial pressure, promoting cardiac arrhythmias. To minimize these effects, it is recommended to perform additional preoxygenation, by increasing the fraction of O2 in the air delivered to the patient by the ventilator 2-3 minutes before the procedure. These longstanding recommendations were reiterated in 2022, based on outdated studies involving systematic suctioning that required disconnecting the patient from the ventilator.
Currently, suctioning are performed on-demand, based on the patient's congestion status, either through the endotracheal tube cap or a "closed system." Desaturations have become infrequent without establishing that additional preoxygenation can prevent them. Moreover, additional preoxygenation is not without risks. By inducing de-nitrogenation atelectasis with a loss of lung volume, it can exacerbate pre-existing lung injuries in the most severe patients. In less severe cases, preoxygenation leads to transient hyperoxia, with various deleterious effects impacting patient prognosis. Thus, a short-term risk, such as deep desaturations, must be balanced against a medium-term risk of hyperoxia and de-nitrogenation.
详细描述
Clearing the airways is a complex phenomenon involving the production of secretions, the nature of mucus (viscosity, elasticity, stringiness, and adhesiveness), ciliary movement, and coughing. Endotracheal suctioning are performed when the patient is "unable to clear the airways of obstructions hindering the free passage of air." Classically, endotracheal suctioning cause transient desaturation exacerbated by a decrease in cardiac output due to an increase in mean arterial pressure, promoting cardiac arrhythmias. To minimize these effects, it is recommended to perform additional preoxygenation, i.e., increasing the fraction of O2 in the air delivered to the patient by the ventilator 2-3 minutes before the procedure. These longstanding recommendations were reiterated in 2022, based on outdated studies involving systematic suctioning and/or disconnecting the patient from the ventilator.
Today, suctioning are performed on-demand, based on the patient's congestion status, either through the endotracheal tube cap or a "closed system." Desaturations have become rare without establishing that additional preoxygenation can prevent them. Moreover, additional preoxygenation is not without risks. In the short term, it induces de-nitrogenation atelectasis resulting in a loss of lung volume that can worsen pre-existing lung injuries in the most severe patients. In less severe cases, preoxygenation is responsible for transient hyperoxia, with various deleterious effects impacting patient prognosis. Thus, a short-term risk, such as deep desaturations, is juxtaposed with a medium-term risk of hyperoxia and de-nitrogenation.
The investigators hypothesize that the absence of additional preoxygenation is not inferior, in terms of deep desaturations, to the strategy with additional preoxygenation, and it would avoid exposing patients to the risks of de-nitrogenation-induced atelectasis and hyperoxia.
The investigators retained a margin of non-inferiority for the relative risk of 1.1, i.e. an increase of 10% of deep desaturations.
The main analysis will be performed on the per-protocol population (more conservative in non-inferiority trials).The per-protocol population will include patients who had at least one suctioning and for whom the additional preoxygenation strategy allocated by randomisation was followed in at least 70% of all suctioning reported in the patient's care record. Patients who stopped their participation in the study before endpoint timeframe and those who had never had an suctioning will not be included in the per protocol population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years of age or older
- •Hospitalized in ICU, under invasive mechanical ventilation for less than 24 hours
- •Information and signature of consent by patient or relative/trusted person, or emergency inclusion procedure
排除标准
- •Patient on ECMO
- •Not affiliated to a social security system
- •Under legal protection (curatorship, guardianship or safeguard of justice)
- •Patient under AME
- •Patient included in another interventional study that may have an impact on the evaluation criteria of the present study
结局指标
主要结局
Rate of suctioning leading to deep desaturation
时间窗: from Day 0 to ventilator weaning, and at the latest Day 28
It will be calculated for each patient as the number of suctioning leading to deep desaturation (SpO2 88% or less, and 85% or less for patients with chronic obstructive pulmonary disease COPD), divided by the total number of endotracheal suctioning throughout the period. Oxygen saturation values will be collected every minute during the 15 minutes post-suctioning. Endotracheal suctioning in patients already ventilated with 100% FiO2 started prior to the decision to aspirate will not be taken into account
次要结局
- Digestive ischemia(From Day 0 to ICU-discharge, and at the latest Day 28)
- Cardiac arrest(From Day 0 to ICU-discharge, and at the latest Day 28)
- Length of hospital stay(at hospital discharge, and at the latest Day 90)
- Number of ventilator free days at D28(From Day 0 to Day 28)
- Ventilator-associated pneumonia(From Day 0 to ICU-discharge, and at the latest Day 28)
- Suctioning rate leading to severe desaturation(From Day 0 to ventilator weaning, and at the latest Day 28)
- Intensive care delirium(From Day 0 to ICU-discharge, and at the latest Day 28)
- Composite criteria of ischemic phenomena in ICU, including one of the following: stroke, myocardial infarction, digestive ischemia(From Day 0 to ICU-discharge, and at the latest Day 28)
- Ischemic stroke(From Day 0 to ICU-discharge, and at the latest Day 28)
- Myocardial infarction(From Day 0 to ICU-discharge, and at the latest Day 28)
- Acute respiratory distress syndrome (ARDS)(From Day 0 to hospital discharge, and at the latest Day 90)
- Acute kidney injury(From Day 0 to ICU-discharge, and at the latest Day 28)
- First bowel movements(From Day 0 to ICU-discharge, and at the latest Day 28)
- ICU discharge vital status(At ICU discharge and at the latest Day 90)
- Hospital discharge vital status(At hospital discharge, and at the latest Day 90)
- Mean saturation over 15 minutes post-suctioning(From Day 0 to ventilator weaning, and at the latest Day 28)
- Absolute variation between saturation before suctioning and minimum saturation over 15 minutes post-suctioning(From Day 0 to ventilator weaning, and at the latest Day 28)
- Length of ICU stay(at ICU discharge, and at the latest Day 90)
- Time in minutes between endotracheal suctioning and eventual desaturation(From Day 0 to ventilator weaning, and at the latest Day 28)
