NCT05174130Unknown不适用
Evaluation of the Therapeutic Usability of RESPIRA ADVANCED Device in Patients Under Invasive Mechanical Ventilation in Stable Phase and in Weaning Phase
Fundacion Clinic per a la Recerca Biomédica6 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2022年5月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 30
- 试验地点
- 6
- 主要终点
- Evaluate blood oxygen pressure (PaO2) changes of patients during the ventilation procedure compared to baseline ventilation
研究概览
简要总结
The objective of the clinical investigation presented is to guarantee the safety and usability of the RESPIRA ADVANCED medical device in patients undergoing mechanical ventilation in the ICU, both stable patients and in the weaning phase. Through the clinical investigation, the reliability and durability of the device, the adequacy of the ventilatory parameters and their consistency over time, and the response of the patients wills be checked. During the entire course of the patient's participation in the study, the patient will be closely monitored following the protocol specifications, to guarantee safety and evaluate the effectiveness of the device.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •Age equal to or greater than 18 years
- •Availability of a family member or legal representative capable of understanding and signing the informed consent
- •Patient admitted to the intensive care unit requiring invasive mechanical ventilation, who shows:
- •Hemodynamic stability: MAP ≥ 65 mmHg and norepinephrine requirements ≤ 0.5 µg / kg / min, and
- •Respiratory stability: PaO2 / Fraction of Inspired Oxygen (FiO2)> 100 and stable oxygen requirements in the previous 6 hours.
- •In case is considered to start phase of "weaning" or awakening, the level of sedation should allow adequate triggering of the inspiratory trigger, in a patient with improvement of respiratory failure and / or radiological image.
排除标准
- •Age under 18 years
- •Weight less than 50 kg
- •Body weight greater than 120 kg
- •Height greater than 1,90 m
- •Presence of barotrauma (pneumothorax) or pleural fistula
- •Hemodynamic instability (MAP < 65 mmHg or norepinephrine requirements > 0,5 µg /kg / min)
- •Neurocritical patient
- •Obstetric patient
结局指标
主要结局
Evaluate blood oxygen pressure (PaO2) changes of patients during the ventilation procedure compared to baseline ventilation
时间窗: This variable will be analyzed at the end of the study (36 hours)
Significant changes in PaO2 during the ventilation of the patient
次要结局
- Evaluate the reliability and temporal consistency of the tidal volume of the device(This variable will be measured and recorded at 24 hours)
- Evaluate the reliability and temporal consistency of the breathing rate of the device(This variable will be measured and recorded at 24 hours)
- Evaluate the reliability and temporal consistency of the inspiration-expiration ratio of the device in the weaning patient's arm(This variable will be measured and recorded at 24 hours)
- Evaluate the oxygen saturation changes of patients during the ventilation procedure compared to baseline ventilation(This variable will be analyzed at the end of the study (36 hours))
- Safety Assessment(This variable will be analyzed at the end of the study (36 hours))
- Evaluate the reliability and temporal consistency of the peak pressure of the device(This variable will be measured and recorded at 24 hours)
- Evaluate the reliability and temporal consistency of the plateau pressure of the device(This variable will be measured and recorded at 24 hours)
- Evaluate the pH changes of patients during the ventilation procedure compared to baseline ventilation(This variable will be analyzed at the end of the study (36 hours))
- Evaluate the breathing rate changes of patients during the ventilation procedure compared to baseline ventilation(This variable will be analyzed at the end of the study (36 hours))
- Protective Measures Assessment(This variable will be analyzed at the end of the study (36 hours))
- Evaluate the failure of the device(This variable will be analyzed at the end of the study (36 hours))
- Evaluate the blood carbon dioxide pressure (PaCO2) changes of patients during the ventilation procedure compared to baseline ventilation(This variable will be analyzed at the end of the study (36 hours))
- Evaluate the heart rate changes of patients during the ventilation procedure compared to baseline ventilation(This variable will be analyzed at the end of the study (36 hours))
研究者
研究点 (6)
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