ISRCTN14092678进行中（未招募）未知
asal high-flow oxygen therapy after cardiac surgery (NOTACS) study: effect of high-flow nasal therapy on patient-centred outcomes in patients at high risk of postoperative pulmonary complications after cardiac surgery: a multicentre randomised controlled trial
适应症
试验速览
- 阶段
- 未知
- 状态
- 进行中（未招募）
- 入组人数
- 1,280
研究概览
简要总结
2022 Interim results article in https://pubmed.ncbi.nlm.nih.gov/35987698/ (added 22/08/2022) 2022 Protocol article in https://pubmed.ncbi.nlm.nih.gov/35346339/ (added 13/07/2023)
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 19/10/2023:
- •1. Aged 18 years or over
- •2. Undergoing any elective or urgent first-time or redo cardiac surgery performed on cardiopulmonary bypass
- •3. Have one or more clinical patient-related risk factor for postoperative pulmonary complications (COPD, asthma, lower respiratory tract infection in last 4 weeks as defined by use of antibiotics, body mass index >=35 kg/m², current (within the last 6 weeks) heavy smokers (>10 pack years)
- •Previous inclusion criteria from 05/07/2023 to 19/10/2023:
- •1. Aged 18 years or over
- •2. Undergoing elective or urgent first-time or redo cardiac surgery performed on cardiopulmonary bypass
- •3. Have one or more clinical patient-related risk factor for postoperative pulmonary complications (COPD, asthma, lower respiratory tract infection in last 4 weeks as defined by use of antibiotics, body mass index >=35 kg/m², current (within the last 6 weeks) heavy smokers (>10 pack years)
- •Previous inclusion criteria:
- •1. Aged 18 years or over
- •2. Undergoing elective or urgent first-time or redo cardiac surgery (CABG, valve surgery, surgery on the aorta or any combination)
- •3. Have one or more clinical patient-related risk factors for postoperative pulmonary complications (COPD, asthma, lower respiratory tract infection in last 4 weeks as defined by the use of antibiotics, body mass index >=35 kg/m², current (within the last 6 weeks) heavy smokers (>10 pack years)
- •For the purposes of the study, the following definitions apply:
- •Asthma is a disease characterized by recurrent attacks of breathlessness and wheezing, and patients will have been prescribed medication by inhalers or nebulisers (either bronchodilators or steroids).
- •Chronic Obstructive Pulmonary Disease (COPD) is an umbrella term used to describe chronic lung diseases that cause limitations in lung airflow. The more familiar terms 'chronic bronchitis' and 'emphysema' are no longer used but are now included within the COPD diagnosis. The most common symptoms of COPD are breathlessness, or a 'need for air', excessive sputum production, and a chronic cough. Patients suitable for the NOTACS study will have been prescribed medication by inhalers or nebulisers (either bronchodilators or steroids).
排除标准
- •1. Requiring home oxygen therapy
- •2. Deep hypothermic circulatory arrest planned
- •3. Contraindication to HFNT, e.g. nasal septal defect
- •4. Requirement for home respiratory support (including: CPAP, BiPAP)
- •5. Requiring emergency cardiac surgery defined as surgery required within 24 hours of the decision to operate
- •6. Patients not fluent in English
研究者
相似试验
已完成
不适用
High Flow Oxygen Therapy Versus Conventional Oxygen Therapy in Cardiac Surgery PatientsHypoxemic Respiratory FailureNCT03282552National and Kapodistrian University of Athens99
进行中（未招募）
不适用
Asymmetrical HFNCO vs Standard HFNCO Post Cardiac Surgery PatientsHypoxemic Respiratory FailureNCT06521489National and Kapodistrian University of Athens63
已完成
不适用
asal High Flow Versus Conventional Oxygen Therapy in Emergency Department Patients With Asthma Exacerbation and Hypoxemia: A Randomized Controlled TrialasthmaTCTR20180926003Siriraj Hospital50
已完成
不适用
asal high - flow - oxygen therapy in patients with hypoxic respiratory failure: Effect on functional and subjective respiratory parameters compared to conventional O2 therapy and non-invasive ventilation (NIV)Acute respiratory failureJ96.0J18.9Pneumonia, unspecifiedDRKS00005132niversitätsklinikum Tübingen14
已完成
3 期
asal High Flow therapy for Children with Acute Hypoxemic Respiratory FailureRespiratory - Other respiratory disorders / diseasesAcute respiratory failureACTRN12618000210279Paediatric Critical Care Research Group1,512