Comparison of Two Methods to Airway Clearance in Patients Admitted to Intensive Care Unit for COVID-19: A Pilot Corssover Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 50
- 主要终点
- SpO2/FIO2 Ratio
研究概览
简要总结
INTRODUCTION As there is no specific cure in the treatment of COVID-19 at this moment of the pandemic, supportive management including mechanical ventilation is the core management in an intensive care unit (ICU). It is a challenge to provide consistent care in this situation of high demand and potential staff shortage in ICU. Also, the investigators need to reduce unnecessary exposure of the providers to the virus. This study aims to examine the impact of care using a non-invasive oscillating device (NIOD) for chest physiotherapy in the care of mechanically ventilated patients with COVID-19.
METHODS Objective: To explore if a NIOD performed by non-specialized personnel is not inferior to the standard Chest PhysioTherapy (CPT) in the care of COVID-19.
Design: A Pilot Multicenter Prospective Crossover Randomized Study. Setting: Two ICUs in Canadian Academic Hospitals (CHU Sainte Justine and Montreal General Hospital) Patients: All the mechanically ventilated patients admitted to the two ICUs, and CPT ordered by the responsible physician, with COVID-19 infection during the study period.
Procedure: The investigators will implement NIOD and CPT alternatingly for 3 hours apart over 3 hours. We will apply a pragmatic design, so that other procedures including hypertonic saline nebulization, Intermittent Positive Pressure Ventilation (IPPV), suctioning (e.g., oral or nasal), or changing the ventilator settings or modality can be provided at the direction of bedside intensivists in charge. The order of the procedures (i.e. NIOD or CPT) will be randomly allocated.
Measurements and Analyses: The primary outcome measure is the oxygenation level before and after the procedure (SpO2/FIO2 (SF) ratio). For the cases with Invasive ventilation and non-invasive ventilation, the investigators will also document expiratory tidal volume, vital signs, and any related complications such as vomiting, desaturations, or unexpected extubations. The investigators will collect the data before, 10 minutes after, and 30 minutes after the procedure.
Sample Size: The investigators estimate the necessary sample size as 25 for each arm (Total 50 cases), with a power of 0.90, alfa of 0.05, with the non-inferiority design.
FUTURE CONSIDERATIONS This randomized pilot study will be considered a running phase if the investigators can/should undertake the RCT which should follow without significant modification of the methods.
详细描述
- BACKGROUND During COVID-19 pandemic, although the proportion of severe or fatal cases may vary by location, 15-30% of hospitalized patients were admitted to the intensive care unit in Italy and China (1-4).
Pneumonia appears to be the most frequent serious manifestation of infection. In addition to respiratory symptoms, gastrointestinal symptoms have also been reported (2, 3, 5). The symptomatic infection can range from mild to critical; but, generally, the clinical course seems to have characteristics of slow progression from upper airway to the lower and the other systemic organs such as cardiac muscles. Radiographic findings include ground-glass opacities, crazy paving appearance, air space consolidation, broncho-vascular thickening in the lesion with a slow progression up until 10-14 days from the onset of disease (6-8).
Staff Shortage & Protection Protecting the workforce is another critical challenge. Sick leaves or self-isolation has increased already. Caring for infected patients represents a substantial exposure risk for ICU staffs because of high and prolonged exposure to critically ill patients who presumably have higher viral shedding. This should be particularly noted for physiotherapists to whom chest physiotherapy can be prescribed more often than usual in this situation of ICU demand. On the other hand, only a limited number of physiotherapists are available in most of ICUs.
Airway obstruction due to the production of secretion particularly with respiratory muscle weakness in critically ill is a major problem in clinical management. CPT has been proposed to assist in the clearance of tracheobronchial secretions. Techniques such as the conventional CPT with chest percussion and vibration, chest shaking and directed coughing may help to mobilize secretions towards the trachea and trigger coughing that could help to remove the secretions. However, a recent systematic review reported that there is no sufficient evidence to provide CPT in routine practice with a significant heterogeneity of the procedure techniques used (9-13).
Extra-thoracic non-invasive oscillating devices (NIOD) are designed to interrupt the expiratory airflow and can help to secretions clearance. NIOD requires less patient cooperation and could be used without interruptions such as due to coughing or suctioning of secretion. Frequencer® (Dymedso, Montreal Canada) is a NIOD that locally target the affected lung areas. The safety has been attested particularly in patients with cystic fibrosis. In addition, this NIOD can be easily administered by non-specialized personnel such as respiratory therapists or registered nurses (14, 15).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All the patients admitted to the ICUs during the study period will be screened. We will not set any restrictions regarding the timing of the prescription of CPT (i.e., length of ICU stay before screening) for the screening. We will include only if CPT is expected to be used as management at least for the next 24 hours in the ICUs from the time of inclusion. For instance, if CPT will be expected to be discontinued from the management in a day, we will exclude them from the inclusion. CPT can be prescribed for airway clearance with any etiology such as atelectasis at the directions of bedside intensivists in charge of the study date.
- •Specific Inclusion criteria
- •Patients diagnosed as COVID-19
- •Patents strongly suspected its infection and the result of virological testing is pending as of screening.
- •Patients with any type of mechanical ventilation (i.e., Invasive, non-invasive, high flow nasal therapy)
- •Patients are on standard oxygen by mask or nasal cannula and the FiO2 provided can be measurable.
- •Patients who are on respiratory monitoring at least SpO2 can be continuously measurable.
排除标准
- •CPT order will (or is expected to) be discontinued within 12 hours from the inclusion timing. This may include potential discharge from the unit.
- •CPT is not ordered for airway clearance.
- •SpO2 is not stable (SpO2=<80%) with more than 0.60 of FIO2 for ventilated patients including patients on NIV, at least for the previous 1 hour from the screening.
- •SpO2 is not stable (SpO2=<80%) with more than 0.60 of FIO2 for the patients on HFNC, at least for the previous 1 hour from the screening.
- •Bradycardia (HR<50bpm) at any intervention at least 24 hours before the screening.
- •Patients with known pneumothorax, osteomyelitis at ICU admission.
- •Thoracotomy within 1 month from the admission date.
- •Known recent/unhealed rib fractures.
- •Known skin injury of the chest wall.
- •No, obtain of IC.
- •Brain death or vegetated states.
研究组 & 干预措施
NIOD first
In this arm, we will apply for NIOD first which will be performed by non-physiotherapists such as respiratory therapists and bedside nurses. This arm of patients will receive standard CPT at least 3 hours after the NIOD intervention.
干预措施: Chest physiotherapy using a non-invasive oscillating device (Procedure)
CPT first
In this arm, we will apply for CPT first which will be performed by physiotherapists. This arm of patients will receive NIOD procedures which will be performed by non-physiotherapists such as respiratory therapists and bedside nurses at least 3 hours after the CPT intervention.
干预措施: Chest physiotherapy using a non-invasive oscillating device (Procedure)
结局指标
主要结局
SpO2/FIO2 Ratio
时间窗: 10 minutes and 30 minutes from the end of the procedure
Difference before the procedure and 10 minutes from the end of the procedure
次要结局
- Clinical Respiratory severity scores.(10 minutes and 30 minutes from the end of the procedure)
- Blood pressures(10 minutes and 30 minutes from the end of the procedure)
- Heart rates(10 minutes and 30 minutes from the end of the procedure)
- Body temperature(10 minutes and 30 minutes from the end of the procedure)
- Modified Wood Clinical Asthma Score (m-WCAS)(10 minutes and 30 minutes from the end of the procedure)
- Respiratory rate(10 minutes and 30 minutes from the end of the procedure)
- Expiratory tidal lung volume.(10 minutes and 30 minutes from the end of the procedure)
- End-tidal CO2(10 minutes and 30 minutes from the end of the procedure)
研究者
Philippe Jouvet
Professor
St. Justine's Hospital