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临床试验/NCT05802745
NCT05802745已完成不适用

Airway Occlusion Pressure (P0.1) to Predict Extubation Failure in Critically Ill Patients: A Prospective Cohort Study

Cleveland Clinic Abu Dhabi3 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2023年6月1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
120
试验地点
3
主要终点
Extubation failure

研究概览

简要总结

Weaning and extubation are essential steps for the management of critically ill patients when mechanical ventilation (MV) is no longer required. Extubation failure (EF) occurs in approximately 10-30% (1,2) of all patients meeting the readiness criteria and have tolerated a spontaneous breathing trial (SBT). EF is associated with prolonged MV, as well as increased morbidity and mortality (2). Therefore, the early identification of critically ill patients who are likely to experience EF is vital for improved outcomes.

EF can result from different factors (respiratory, metabolic, neuromuscular), particularly cardiac factor, and can be caused by the inability of the respiratory muscle pump to tolerate increases in the cardiac and respiratory load (1,3).

Respiratory drive represents the intensity of the neural stimulus to breathe. In mechanically ventilated patients, it can be abnormally low (i.e., suppressed or insufficient) or abnormally high (i.e., excessive), and thus result in excessively low or high inspiratory effort, leading to potential injury to the respiratory muscles (i.e., myotrauma) (4,5) or to the lungs. A high incidence of abnormal drive (low or high) may explain the high incidence of diaphragm dysfunction at time of separation from mechanical ventilation (6).

Airway occlusion pressure (P0.1) is the drop in airway pressure (Paw) 100 milliseconds after the onset of inspiration during an end-expiratory occlusion of the airway (7). P0.1 measurement is not perceived by the patient and does not influence respiratory pattern. It is, in theory, a reliable measure of respiratory drive because the brevity of the occlusion explains that it is not affected by patient's response to the occlusion and it is independent of respiratory mechanics (8). P0.1 has also been correlated with inspiratory effort (9, 10) and it has been shown that in patients under assisted mechanical ventilation P0.1 might be able to detect potentially excessive inspiratory effort (11).

P0.1 is a non-invasive measure and clinically available at bedside since currently nearly all modern ventilators provide a means of measuring it. Originally, a high P0.1 during a spontaneous breathing trial was associated with failure, suggesting that a high respiratory drive could predict weaning failure. However, only a few and old clinical studies investigated the association between P0.1 and extubation failure (EF) and were not conclusive (12,13). We hypothesized that patients with EF would have increased P0.1 values during spontaneous breathing trial (SBT). Therefore, the aims of our study will be to (1) to evaluate the ability of changes in P0.1 (Delta-P0.1) during SBT to predict EF and (2) to assess if Delta-P0.1 is an independent predictor of EF.

详细描述

Weaning protocol SBTs will be performed in semirecumbent patients on Pressure Support Ventilation (PSV) mode with inspiratory pressure of 5 cmH2O and positive-end-expiratory pressure (PEEP) of 5 cmH2O as per ICU protocol. Inspiratory oxygen fraction (FiO2) will be adjusted for the achievement of an arterial oxygen saturation value > 90%, as measured by pulse oximetry. The SBT duration will be 30 minutes as per ICU protocol. The criteria that will be used for poor SBT tolerance are: (1) diaphoresis; (2) use of accessory respiratory muscles; (3) RR > 35/min; (4) oxygen saturation by pulse oximetry < 90% with FiO2 ≥ 50%; (5) HR > 140/min or greater than a 20% increase from baseline; (6) Systolic blood pressure >180 mmHg or <90 mmHg; (7) development of cardiac arrhythmias; and/or low level of consciousness.

The decision to stop SBT will be made by the physicians. Patients who will fail SBT will be shifted to their previous ventilator mode and not be enrolled in the study.

Patients who will complete the SBT will be extubated and followed-up for 72 hours. The medical team (physician, nurse, and respiratory therapist) involved in the extubation decision will be blinded to the P0.1 results. EF will be diagnosed if the patient is extubated but required reintubation within the following 72 hours. Criteria for acute respiratory failure after extubation are the development of at least one of the following: (a) respiratory acidosis with pH < 7.32 and arterial CO2 pressure (PaCO2) > 45 mmHg; (b) arterial oxygen saturation < 90% with FiO2 > 0.5; (c) RR > 35/min; (d) clinical signs of respiratory fatigue.

The management of post-extubation respiratory failure will not be protocolized and will be left to the physician's discretion.

Ventilatory, including P0.1 and hemodynamic parameters, including EtCO2 will be recorded as the average of at least three measurements immediately before SBT, during SBT, and at 30 minutes after SBT initiation. Arterial and central venous blood gas (if central line present) will be measured immediately before SBT and at 30 minutes after SBT initiation.

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

  • - All patients aged 18 years or older who received mechanical ventilation for at least 48 hours and satisfied the weaning criteria will be eligible for enrollment.
  • The readiness-to-wean criteria that will be employed are: (1) the resolution or improvement of the underlying cause of respiratory failure for which the patient was intubated; (2) hemodynamic stability, defined as heart rate (HR) < 140/min and systolic blood pressure between 90 and 160 mmHg with no or minimal doses of vasopressors; (3) stable respiratory status, defined as oxygen saturation > 90% with fraction of inspired oxygen (FiO2) ≤ 0.5 and positive end expiratory-pressure (PEEP) ≤8 cmH2O, respiratory rate (RR) ≤ 35/min, spontaneous tidal volume (Vt) > 5 mL/kg, and no significant respiratory acidosis; (4) adequate mental status, and (5) adequate cough.

排除标准

  • Presence of tracheostomy
  • Do-not-reintubate orders
  • pregnancy
  • Absence of informed consent
  • Spontaneous breathing trial failure.

研究组 & 干预措施

Extubation failure

Patients who will require to be re-intubated within 72 hours after extubation.

干预措施: Reintubation (Other)

Extubation success

Patients who will not require reintubation within 72 hours of extubation.

结局指标

主要结局

Extubation failure

时间窗: Within 72 hours after extubation.

to evaluate the ability of changes in P01 (Delta-P0.1) during SBT to predict extubation failure after 72 hours of extubation.

次要结局

  • Delta-P01 as independent factor of extubation failure(Within 72 hours after extubation.)
  • Extubation failure(7 days after extubation)

研究者

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

Jihad Mallat

Staff Physician

Cleveland Clinic Abu Dhabi

研究点 (3)

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