ISRCTN31060062已完成2 期
A randomised controlled trial of targeted oxygen therapy in mechanically ventilated critically ill patients.
niversity College London0 个研究点目标入组 60 人开始时间: 2018年3月7日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
研究概览
简要总结
2019 Protocol article in https://pubmed.ncbi.nlm.nih.gov/30659035/ (added 28/06/2022)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Current inclusion criteria as of 29/11/2018:
- •1. Unplanned admission to a critical care unit
- •2. 18 years of age and above (no upper age limit)
- •3. Respiratory failure forms part of the admission diagnosis
- •4. The patient is mechanically ventilated via an endotracheal tube
- •5. The patient is expected to receive mechanical ventilation for > 24 hours
- •N.B. In the TOXYC trial, the trigger for inclusion is at the point of intubation and not at admission. E.g. A subject that is admitted but not intubated is not eligible but a subject who deteriorates to the point of requiring intubation and is then intubated then becomes eligible. Once a subject is intubated, site has 24 hours to gain the appropriate consent, enrol and randomise the subject, should site chose to
- •Previous inclusion criteria:
- •1. Unplanned admission to a critical care unit
- •2. 18 years of age and above (no upper age limit)
- •3. Respiratory failure forms part of the admission diagnosis
- •4. The patient is mechanically ventilated via an endotracheal tube
- •5. The patient is expected to receive mechanical ventilation for > 72 hours
- •N.B. In the TOXYC trial, the trigger for inclusion is at the point of intubation and not at admission. E.g. A subject that is admitted but not intubated is not eligible but a subject who deteriorates to the point of requiring intubation and is then intubated then becomes eligible. Once a subject is intubated, site has 24 hours to gain the appropriate consent, enrol and randomise the subject, should site chose to
排除标准
- •1. Admission following surgery (elective or unplanned)
- •2. Those patients expected to die within 24 hours of admission to ICU *
- •3. Pregnant females
- •4. Admission post-cardiac arrest
- •5. Patients with chronic lung disease known (or highly suspected) to have baseline oxygen saturations in the range of the intervention arm (i.e. 88-92%)
- •6. Admission post trauma (including traumatic brain injury)
- •7. Known sickle cell trait or disease
- •8. Ongoing significant haemorrhage or profound anaemia
- •9. Severe peripheral vascular disease
- •10. Severe pulmonary hypertension
- •11. Other medical conditions where mild hypoxaemia would be contraindicated **
- •12. Patients participating in other interventional clinical trials
- •* As determined by the responsible clinical team
- •** As determined by the responsible clinical team and/or research team
研究者
相似试验
已完成
不适用
Targeted OXYgen Therapy in Critical IllnessCritical IllnessRespiratory FailureNCT03287466University College, London34
尚未招募
2 期
The effect of targeted oxygen therapy on the recovery outcomes of Covid-19 patientsIRCT20211116053079N1Bagheiat-allah University of Medical Sciences80
进行中（未招募）
3 期
PROVE Trial - Positive pRessure therapy in COVid-19 infEctionCTRI/2021/04/033175George Institute for Global Health India
已完成
不适用
Optimisation of perioperative cardiovascular management to improve surgical outcome IIISRCTN39653756Queen Mary University of London2,502
已完成
不适用
SlowMo trial: a digital therapy for people who fear harm from othersParanoiaMental and Behavioural DisordersDelusional disorderISRCTN32448671King's College London362