NCT02958150Unknown4 期
Randomised Clinical Trial: Dexmedetomidine Versus Standard Clinical Practice During Non Invasive Mechanical Ventilation
Basque Health Service1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2016年10月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- To determinate the percentage of orotracheal intubations, and thus the need for NIV during the trial.
研究概览
简要总结
This study compare the effectiveness of dexmedetomidine as a sedative drug during NIV and the different strategies routinely used in patients with ARF of different aetiologies. Efficacy will be assessed based on absence of intubation, short term prognosis, and occurrence of medical complications.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients over 18 years of age.
- •Competent or with legal representative able to sign inform consent.
- •Reversible ARF secondary to heart failure, COPD exacerbation, pneumonia, or at risk of pot-extubation failure* who meet the criteria for starting NIV.
- •Signs and symptoms of respiratory distress or
- •Moderate to severe dyspnoea, grater than usual and/or
- •Respiratory rate greater than 25 in COPD or greater than 30 in hypoxemic ARF and/or
- •Use of accessory muscles and/or paradoxical breathing and/or
- •Hypercapnic encephalopathy
- •And changes in gas exchange
- •PaCO2>45 mmHg, pH<7.35 and/or
- •PaO2/FiO2 between 300 and
- •*Patients at risk of post-extubation failure: Patients who meet at least one of the following criteria.
- •Impaired consciousness.
- •Age over 65 years
- •Heart failure with EF >30%
- •Severe disease with an Acute Physiology and Chronic Health Evaluation (APSCHE) score >
- •Protracted weaning before extubation
排除标准
- •Respiratory arrest, direct indication of OTI and IMV.
- •Severe unstable comorbidity (myocardial ischemia with ejection fraction <30%, arrythmia, uncontrolled hypotension defined as systolic blood pressure less than 90 mmHg with doses of norepinephrine>0.5 mcg/kg/min and/or dobutamine>10 mcg/kg/min).
- •Inability to protect the airway: bronchial aspiration.
- •Fixed upper airway obstruction.
- •Tracheostomy.
- •Undrained pneumothorax.
- •Severe agitation or lack of collaboration of the patient despite medication administered.
- •Facial burns or trauma.
- •Facial surgery or anatomical changes which prevent mask fitting.
- •Hypersensitivity to the active substance or to any of the excipients listed in section 6.
- •Allergy to eggs, soya, or peanuts.
- •HR< 50 bpm not induced by beta- blockers.
- •Advanced heart block (grade 2 or 3) unless paced.
- •Acute cerebrovascular conditions.
- •Increased intracranial pressure.
- •Closed angle glaucoma.
- •Myasthenia gravis.
- •Concurrent use of CYP3A4 inhibitors (amprenavir, atazanavir, or ritonavir).
- •Refuse to participate in the trial.
- •Pregnant or nursing patients.
研究组 & 干预措施
Dexmedetomidine
Experimental
Dexmedetomidine according to the stablished protocol
干预措施: Dexmedetomidine (Drug)
Standard Clinical Practice
Active Comparator
The physician in charge will decide the treatment to be administered (if deemed necessary) in accordance with the protocol established at the department
干预措施: Standard Clinical Practice (Procedure)
结局指标
主要结局
To determinate the percentage of orotracheal intubations, and thus the need for NIV during the trial.
时间窗: 72 hours
Need for intubation is defined as the presence of any of the following: SpO2\<80% or P aO2/FiO2\<150, seizures, poor secretion management, hypercapnia and pH\<7.20, hypotension: systolic blood pressure (SBP)\<80 mmHg refractory despite administration of vasoactive amines or electrocardiogram (ECG) with ischaemic changes or ventricular arrhythmia resulting from myocardial hypoxia.
次要结局
- To analyse hospital stay in each group(15 days)
- To compare all-cause mortality at the ICU in both groups.(Through study completion, an average of 3 years)
- To analyse all-cause hospital mortality.(Through study completion, an average of 3 years)
- To report the course of ARF in each group.(1 and 24 hours after NIV)
- To determinate NIV duration of NIV in each group.(72 hours)
- To report the adverse effects of dexmedetomidine.(During drug administration and up to 24 hours after drug infusion is completed.)
- To compare specific mortality at the ICU in both groups.(Through study completion, an average of 3 years)
- To report NIV tolerance during administration of dexmedetomidine versus SCP.(During administration of dexmedetomidine/SCP and up to 24 hours after drug infusion/SCP is completed.)
- To analyse stay at the ICU in each group.(An average of 5 days)
- To analyse hospital-specific mortality.(Through study completion, an average of 3 years)
- To asses patient satisfaction with dexmedetomidine as compared to SCP(Through study completion, an average of 3 years)
研究者
Ana Vallejo de la Cueva
Registered Doctor
Basque Health Service
研究点 (1)
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