Cuff Leak Test and Airway Obstruction in Mechanically Ventilated ICU Patients (COSMIC): a Pilot Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 5
- 主要终点
- Recruitment Rate
研究概览
简要总结
The COSMIC trial will be a multicentred, national, parallel-group, pragmatic vanguard pilot trial.
详细描述
The COSMIC trial will be a multicentred, national, parallel-group, pragmatic vanguard pilot trial in adults (≥18 years) who are mechanically ventilated in the ICU with risk factors for LE and an order to extubate has been provided by the treating physician.
The aims of this study are to assess:
- Protocol adherence
- Recruitment rates
- Secondary clinical outcomes will be collected, and if feasibility criteria are met, ultimately used in the powered trial pending no major protocol adjustments (otherwise will be reported as cohort data).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Outcomes Assessor)
盲法说明
The Research Coordinator will randomize eligible patients in a 1:1 allocation using undisclosed variable block sizes through a central computer system on REDCap. Randomization algorithm will stratify patients by recruitment site. This is an unblinded study as group allocation will be known. However, outcome adjudicators and the study statistician will be blinded to the group allocation.
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
- •≥18 yrs. of age
- •Mechanically ventilated in the ICU \
- •An order to extubate has been provided by the treating physician
- •Meet at least 1 criteria for risk factors for Laryngeal Edema(LE):
- •Criteria 1
- •Intubated for >5 days
- •Criteria 2 *must fulfill category 1 and ≥1 risk factor in category 2
- •Category 1
- •Intubated for >48 hours
- •Category 2
- •An unplanned extubation event within the last week
- •Airway trauma secondary to an endotracheal intubation during the past week defined as one of the following:
- •More than one attempt at direct laryngoscopy
- •More than one attempt to pass the ETT
- •Charted as a traumatic intubation
- •A body mass index of >30kg/m2
- •An endotracheal tube greater than 8mm in a man or 7mm in a woman
- •A total positive cumulative fluid balance of at least >1500ml/d x # of days admitted to ICU (eg. If admitted for 4 days, the patient will meet this criterion if they are 6L positive during their length of ICU admission)
- •Physician concern about possible laryngeal edema for a reason not previously listed above. For example:
- •Prone or Trendelenburg position in a recent operation
- •Agitation defined as a RASS of 3+ or more or a SAS of 6 or more that may result in airway injury
排除标准
- •Palliative care plan or plan of care does not include re-intubation, Decision to withdraw life support, or no plan for re-intubation
- •Known pregnancy: Current pregnancy or up to and including 7 days postpartum
- •Patients with highly suspected laryngeal injury: Burn patients, smoke inhalation injuries, blunt or penetrating trauma of the neck and airway, recent head and neck surgeries, and patients admitted with airway edema
- •Known pre-existing tracheolaryngeal abnormalities: Vocal cord paralysis, tracheolaryngeal neoplasm, tracheomalasia, tracheolaryngeal stenosis, or previous head and neck surgeries
- •Mechanical ventilation via a tracheostomy
- •High dose steroids administered within the previous 72h (Prednisone 1mg/kg oral equivalent)
- •The ICU physician believes the patient should have a CLT performed
- •Patient had a failed CLT in the previous 24 hours
研究组 & 干预措施
Intervention - Cuff Leak Test
A respiratory therapist will perform a Cuff Leak Test on all patients prior to extubation. If no air leak is auscultated (a failed CLT), extubation will be delayed. During this time, the patient will receive dexamethasone 4mg intravenous every 6 hours for 12-24 hours and the clinical team will be advised to consider optimizing a patient's fluid status through either diuresis or ultrafiltration if the patient has renal failure. After 12-24 hours, and once the clinical team decides the patient is ready for another extubation attempt, the CLT will be repeated. If the patient fails the CLT again, it will be at the discretion of the clinical team how to proceed (i.e. continue steroid administration, and further delay extubation vs immediately extubating despite a failed CLT) (Figure 3). A passed CLT at any time point will result in immediate extubation.
干预措施: Cuff Leak Test (Diagnostic Test)
Intervention - Cuff Leak Test
A respiratory therapist will perform a Cuff Leak Test on all patients prior to extubation. If no air leak is auscultated (a failed CLT), extubation will be delayed. During this time, the patient will receive dexamethasone 4mg intravenous every 6 hours for 12-24 hours and the clinical team will be advised to consider optimizing a patient's fluid status through either diuresis or ultrafiltration if the patient has renal failure. After 12-24 hours, and once the clinical team decides the patient is ready for another extubation attempt, the CLT will be repeated. If the patient fails the CLT again, it will be at the discretion of the clinical team how to proceed (i.e. continue steroid administration, and further delay extubation vs immediately extubating despite a failed CLT) (Figure 3). A passed CLT at any time point will result in immediate extubation.
干预措施: Dexamethasone 4mg (Drug)
结局指标
主要结局
Recruitment Rate
时间窗: 1 Year
Define a successful recruitment rate as enrolling three patients per centre per month over the duration of the trial. While the pilot trial is ongoing, steering committee will review recruitment weekly and the screening records monthly. If applicable, we will address barriers to enrolment to maximise recruitment. The recruitment metric will be measured and interpreted at the end of the pilot trial by calculating the mean number of recruited patients per active screening month.
Protocol Adherence
时间窗: 30 days
Define a successful adherence rate as ≥75%. We will calculate the adherence as the proportion of patients that are assigned to the intervention arm following the appropriate treatment algorithm and those assigned to the control arm being extubated without a cuff leak test. As this pilot trial is ongoing, we will review adherence monthly and investigate the reasons for compliance failure. We will investigate all reasons for failure to follow the treatment algorithm in the intervention arm, failure to extubate after a patient passes a CLT in the intervention arm, or failure to extubate immediately after randomization in the control arm and report them as a protocol violation. The RC will review the RT's charting and the medication profile to determine actual compliance. RC will record all reasons for non-compliance using distinguishing clinical reasons (eg, palliation, death, consent withdrawal and errors).
次要结局
- Proportion of patients with Clinically Significant post-extubation stridor(within 72 hours of extubation;)
- Proportion of patients with Emergency Surgical Airway(within 72 hours of extubation)
- Proportion of patients with Ventilator Associated Pneumonia(30 Days from Randomization)
- Proportion of patients Reintubation(within 72 hours of extubation;)
- Proportion of patients with Post-extubation stridor(within 72 hours of extubation)
- Ventilator Free Days(Within 30 Days of Randomization)
- Length of Stay(Within 30 days of Randomization)
- ICU Length of Stay(Within 30 days of Randomization)
- Hospital Mortality(Within 30 days of Randomization)
- ICU Mortality(Within 30 days of Randomization)
研究者
Kimberley Lewis
Principal Investigator, SJHH Staff Intensivist, Assistant Professor
St. Joseph's Healthcare Hamilton