A Randomised, Feasibility Trial of Simultaneous Application of Flow at Extubation (SAFEx) in Patients Requiring Intubation and Ventilation for the Management of Acute Respiratory Failure
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2
- 试验地点
- 2
- 主要终点
- The recruitment rate to the study over 12 months with 1:1 randomisation of participants between SAFEx treatment and standard care.
研究概览
简要总结
The goal of this feasibility study is to learn whether a new approach to breathing tube removal within the Intensive Care Unit is safe and acceptable to participants who require a breathing tube for the management of severe breathing difficulties. The main questions it aims to answer are:
- What is the recruitment rate to the study over 12 months?
- Is the study design acceptable and safe to participants?
Participants will receive high flow nasal oxygen before their breathing tube is removed. The investigators will compare this with standard practice of applying conventional, low-flow oxygen after the breathing tube removed to see if this effects the rate of repeat breathing tube insertion.
The investigators hypothesise that they will recruit 30 participants to the study protocol (15 participants in each group) over 12 months and that our study protocol will be tolerable and acceptable to participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
盲法说明
Participants will be randomised in a 1:1 manner using a computer-generated 30 number sequence of '1s' and '2s' from https://www.random.org/ between 1) SAFEx treatment and 2) standard care. A clinician, not involved in the study, will obtain this 30 number sequence and conceal its order within 30 sealed, opaque, numbered envelopes. The investigators will be blinded to the participant's allocation until they have been enrolled in the study, after which the next envelope in the sequence will be opened and treatment allocation will be unblinded.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant aged 18 to 80 years old at time of recruitment to study)
- •Ventilated for greater than or equal to 48 hours with respiratory failure
- •Treating clinician agrees ready for a planned extubation (but pressure support ventilation, fraction of inspired oxygen less than or equal to 40 , positive end expiratory pressure less than or equal to 10 centimetres of water, Respiratory rate less than 20 breaths per minute)
- •Minimal secretions
- •Neurologically intact (In the opinion of the treating clinician, the participant is unlikely to fail extubation due to their neurological status)
- •Cardiovascularly stable (systolic blood pressure greater than or equal to 70 millimetres of mercury, heart rate less than or equal to 150 beats per minute)
- •Written informed consent
排除标准
- •Cardiac Implant Device
- •Internal Neurostimulator
- •Unstable Spinal Fracture or Spinal Cord Injury
- •Body Mass Index >50kg/m^2
- •Skin lesions or dressings over electrode belt site
- •Pregnancy or Lactating
- •Intercostal Chest Drain (at treating clinician's discretion)
- •Severe type II respiratory failure (arterial partial pressure of carbon dioxide greater than or equal to 12 kilopascals)
- •Severe acidosis (Hydrogen ion concentration greater than or equal to 80 nanomoles per litre)
- •Chronic respiratory disease limiting functional capacity (MRC breathlessness grade IV or V)
- •Severe heart failure (New York Heart Association Grade III or IV)
- •Decreased GCS
- •Cardiovascular instability (systolic blood pressure less than or equal to 69 millimetres of mercury or heart rate greater than or equal to 151 millimetres of mercury )
- •Pulmonary embolism
- •Nasal obstruction
- •Previous bleomycin administration
- •Base of skull fracture
- •Life expectancy less than or equal to 3 months
研究组 & 干预措施
SAFEx
Electrical Impedance Tomography recording is commenced 15 minutes prior to planned extubation. High Flow Nasal Therapy (HFNT) is commenced at least 10 minutes prior to planned extubation. At 5 minutes before extubation, the flow rate of HFNT should be established at 60 litres per min (or as high as can be tolerated by the participant) and the fraction of inspired oxygen (FiO2) set at 40 percent. Prior to extubation, endotracheal, infraglottic and supraglottic suctioning are performed. Then, the cuff is let down followed by immediate extubation with simultaneous application of HFNT. 10 minutes after extubation, the FiO2 is weaned in a protocolised manner to 21 percent - or as close to 21 percent as possible over 25 minutes. If the participant is safely weaned onto room air, the flow rate of HFNT is then reduced in a protocolised manner over 120 minutes: 60 minutes at 60 litres per minute (or the highest flow rate tolerated) and then 60 minutes at 30 Litres per minute.
干预措施: Fisher and Paykel "HealthCare Airvo™ 3" high flow system (Device)
Standard Care
Electrical Impedance Tomography recording commenced 15 minutes prior to planned extubation. Prior to extubation, endotracheal, infraglottic and supraglottic suctioning are performed. Then, the cuff is let down followed by immediate extubation on to low flow conventional oxygen with a fraction of inspired oxygen of up to 40 percent. Then, the participant is weaned at the discretion of their clinician over the next 2 hours and 35 minutes.
干预措施: Conventional Oxygen Therapy (Device)
结局指标
主要结局
The recruitment rate to the study over 12 months with 1:1 randomisation of participants between SAFEx treatment and standard care.
时间窗: 12 months
The associated end point will be the average rate of recruitment per month over 12 months of participants who complete the full study protocol (with a set upper limit of 30 participants recruited to the protocol over 12 months corresponding to a recruitment rate of 2.5 participants per month).
次要结局
- The incidence of Adverse Events and Serious Adverse Events associated with trial procedures.(72 hours)
- Patient Visual Analogue Scale scores for questions exploring the tolerability of SAFEx treatment compared with that of standard care.(72 hours)
- The rate of completion of the SAFEx weaning protocol.(2 hours 50 minutes)
- The reintubation rate in each group.(72 hours)
- Withdrawal rate from the study.(72 hours)
- The duration of weaning tolerated before desaturation occurred.(2 hours 50 minutes)
- The change in global electrical impedance between each group.(2 hours 50 minutes)
- The failure rate of Electrical Impedance Tomography measurement.(2 hours 50 minutes)
- The participant self-rated Visual Analogue Scale score for questions exploring the tolerability of Electrical Impedance Tomography Measurement.(72 hours)