ACTRN12619000901101已完成未知
Automatic versus manual oxygen titration using a novel nasal high-flow oxygen delivery device in adults hospitalised with an acute illness: a randomised controlled trial
Fisher and Paykel Healthcare0 个研究点目标入组 20 人开始时间: 2019年6月27日最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •Inclusion Criteria: Target SpO2 88-82%
- •1) Current inpatient under the care of a medical or surgical team
- •2) Expected duration of admission >24 hours from enrolment
- •3) Target SpO2 of 88-92% documented by clinical team
- •4) NHF therapy already commenced OR treating physician decision to start NHF OR requirement for greater than or equal to 1L/min low-flow oxygen
- •Inclusion Criteria: Target SpO2 92-96%
- •1) Current inpatient under the care of a medical or surgical team
- •2) Expected duration of admission >24 hours from enrolment
- •3) Target SpO2 of 92-96% documented by clinical team
- •4) NHF therapy already commenced OR treating physician decision to start NHF OR requirement for greater than or equal to 2L/min low-flow oxygen
排除标准
- •Common Exlusion Criteria:
- •1) Age < 18
- •2) Unable to tolerate a brief interruption in oxygen therapy
- •3) Domiciliary use of CPAP or NIV
- •4) Diagnosis of obstructive sleep apnoea
- •5) Evidence of respiratory infection or colonization with multidrug resistant bacteria, Pseudomonas species, Burkholderia Cepacia or mycobacteria
- •6) Haemodynamic instability (systolic blood pressure <90mmHg or requirement for vasopressor or inotropic support)
- •7) Patient receiving end of life care
- •8) Risk of barotrauma (as assessed by the investigator)
- •9) Nasal or facial conditions precluding use of NHF
- •10) Intracranial trauma or trans-nasal neurosurgery (within 6 weeks)
- •11) Any condition which limits the feasibility of continuous SpO2 monitoring using a finger probe such as anatomical deformity or vascular compromise.
- •12) Pregnancy or breastfeeding
- •13) Cognitive impairment or impaired consciousness precluding informed consent
- •14) Implanted electronic medical device (including insulin pump, pacemaker, neurostimulator and implantable cardioverter-defibrilator)
- •14) Any other condition which, at the investigator’s discretion, is believed may present a safety risk or impact the feasibility of the study or the study results
- •Exclusion Criteria: Target SpO2 88-92%
- •1) Requirement for > 35% oxygen at time of enrolment (equivalent to 4L/min low-flow oxygen)
- •2) Respiratory acidosis (pH <7.35 and pCO2 >45mmHg)
- •Patients with a target SpO2 range of 88-92% and compensated hypercapnia will be eligible for inclusion, however those with a respiratory acidosis will be excluded from the study.
- •Exclusion Criteria: Target SpO2 92-96%
- •1) Requirement for > 40% oxygen at time of enrolment (equivalent to 5L/min low-flow oxygen)
- •2) Hypercapnia (pCO2 >45mmHg) with or without acidosis
- •3) Presence of any risk factor for hypercapnic respiratory failure including: COPD, cystic fibrosis, bronchiectasis, chest wall deformity or neuromuscular disease AND investigator considers 92-96% to be an inappropriate SpO2 target.
研究者
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