Mechanical Insufflation-Exsufflation (Cough Assist) in Critically Ill Adults (ACACIA)-a Randomized Clinical Feasibility Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- intervention delivery
研究概览
简要总结
The goal of this randomized feasibility trial is to evaluate the feasibility of Mechanical Insufflation-Exsufflation (MI-E) in invasively ventilated critically ill patients.
The main question[s] it aims to answer are:
- Is MI-E feasible?
- Is MI-E safe?
Participants in the intervention group will receive:
- MI-E
- Airway secretions will be removed by endotracheal suctioning, as part of routine airway care.
- Manual hyperinflation will only be used when necessary in an emergency situation. Patients in the control group will receive endotracheal suctioning and manual hyperinflation when clinically indicated.
The primary outcome is the proportion of delivered MI-E sessions (2 times per calendar day a MI-E session of 3 x 3 cycles of an in- and exsufflation) per patient according to study protocol (feasibility). Secondary outcomes are the total number of serious adverse events in relation to MI-E (safety) and preliminary exploratory data on the need for airway care interventions and clinical outcomes including duration of invasive ventilation, length of stay in ICU and mortality (efficacy).
详细描述
Bedside nurses, trained in using the MI-E device, will apply MI-E sessions at two moments per calendar day (morning and afternoon) for a maximum of 7 days while a patient is invasively ventilated.
MI-E settings are a 2-second insufflation and an immediate 2-second exsufflation. The cycles of the MI-E session will be performed with a positive and negative pressure of 40 cmH2O. The program is set up with the possibility of auto-triggering by the patient.
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
盲法说明
Due to the nature of the intervention, blinding of healthcare professionals and any research personnel involved in the delivery of the intervention is not possible.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •admission to one of the participating ICUs;
- •receiving invasive mechanical ventilation via an endotracheal tube; and
- •expected to need invasive ventilation for more than 48 hours from consideration for inclusion.
排除标准
- •use of MI-E before hospital admission, i.e., at home;
- •known presence of bullous emphysema;
- •known bronchopleural fistula;
- •known pneumothorax or pneumomediastinum;
- •known rib fractures;
- •known barotrauma;
- •known unstable spinal fractures;
- •unsecured subarachnoidal haemorrhage;
- •uncontrollable intracranial pressures; and
- •any infection, or colonization with pathogens that requires strict aerogenic isolation. With an exception for patients in cohort isolation due to COVID-19.
结局指标
主要结局
intervention delivery
时间窗: max. 7 days
the proportion of complete sessions of MI-E every calender day (i.e. two MI-E sessions with 3 x 3 cycles of an in- and exsufflation) for all patients with a maximum of seven days of invasive ventilation
次要结局
- incidence of severe hypertension (safety)(max 7 days)
- VAP (efficacy MI-E sample size calculation)(28 days after inclusion)
- duration MV (efficacy MI-E sample size calculation)(28 days after inclusion)
- incidence of severe hypoxemia (safety)(max 7 days)
- VFD-28 (efficacy MI-E sample size calculation)(28 days after inclusion)
- hospital mortality (efficacy MI-E sample size calculation)(28 days after inclusion)
- amount of time needed for MI-E (feasibility)(maximum of 1 hour per session)
- LOS ICU (efficacy MI-E sample size calculation)(28 days after inclusion)
- incidence of pneumothorax (safety)(max 7 days)
- incidence of endotracheal tube obstruction (safety)(max 7 days)
- incidence of severe hypotension (safety)(max 7 days)
- Feasibility of Intervention Measure (FIM)(through study completion, estimated one year)
- LOS hospital (efficacy MI-E sample size calculation)(28 days after inclusion)
- Acceptability of Intervention Measure (AIM)(through study completion, estimated one year)
- Intervention Appropriateness Measure (IAM)(through study completion, estimated one year)
- endotracheal suctioning (feasibility)(max. 7 days)
- MH (feasibility of MI-E)(max. 7 days)
- ICU mortality (efficacy MI-E sample size calculation)(28 days after inclusion)
- supplemental oxygen (efficacy MI-E sample size calculation)(28 days after inclusion)
- Mortality day 28 (efficacy MI-E sample size calculation)(up to day 28 from ICU admission)
研究者
Prof. Dr. Marcus J. Schultz
Prof. dr.
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)