Study of the Relationship Between the Relative Variation of PaO2/FiO2 and the Variation of Lung Ultrasound Score During the First Session of Physiotherapy Associated With Non-invasive Ventilation in Cardiac Surgery Patients by Cardiopulmonary Bypass
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Relative difference in PaO2/FiO2 ratio: (measurement after - measurement before the physiotherapy session + non invasive ventilation) / measurement before.)
研究概览
简要总结
After conventional cardiac surgery, many respiratory complications are possible. Therefore, the resuscitator prescribe physiotherapy and non invasive ventilation. The physiotherapist has few reliable tools to evaluate and follow the patient on his ventilatory function. Currently, lung ultrasound is little used in physiotherapy and no study explains the link between the lung ultrasound results and oxygenation patient state. Before considering the interest of lung ultrasound score as a criterion of effectiveness of a physiotherapy treatment through future studies, it is first important to objectivize the existence of a relationship between lung ultrasound score and the PaO2/FiO2 ratio after cardiac surgery. Lung ultrasound could provide direct clinical information without having to resort to other more invasive examinations to objectify the improvement of the patient's oxygenation.
Main objective To show that the relative change in the PaO2/FiO2 ratio correlates with the change in lung ultrasound score measured in the short term between the beginning and the end of the first physiotherapy session associated with non invasive ventilation the day after surgery in cardiac patients
Secondary objectives
- To study the inter-operator (2 readers) reproducibility of the lung ultrasound score measurement.
- To study the relationship between the relative variation of the PaO2/FiO2 ratio and the variation of each of the 12 zones of the lung ultrasound score
- To Study the relationship between the initial lung ultrasound score and the relative variation of the PaO2/FiO2 ratio
- To study the relative variation of the PaCO2 and the variation of the lung ultrasound score between the beginning and the end of the first session of physiotherapy management associated with NIV
- To obtain from the patient in the short term feedback on his or her understanding of the explanations about lung ultrasound score provided by the physiotherapist during the session
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
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
- •Person having received complete information on the organization of the research and having given written consent to participate
- •Person having benefited from a heart surgery under cardio-pulmonary bypass
- •Medical prescriptions for non invasive ventilation and physiotherapist
- •Age ≥ 18 years
- •18.5 ≤ BMI ≤ 35 kg/m2
- •Visual Analogy Scale pain < 4
- •Patient conscious and oriented: Glasgow 15/15
排除标准
- •At the patient's request : a patient may withdraw from the research at any time without affecting the quality of care to which he or she is entitled (withdrawal of consent).
- •Cardiorespiratory arrest during the inclusion visit.
- •Need for orotracheal reintubation during the inclusion visit.
- •Patient non-cooperation during the inclusion visit.
- •Failure of the ultrasound machine during the inclusion visit.
- •Failure of the blood gas analyzer.
- •Glasgow < 15 during the inclusion visit
- •PEEP > 6 cmH2O required during physiotherapy + non invasive ventilation session
- •PEEP < 6 cmH2O required during physiotherapy + non invasive ventilation session
- •Premature interruption of the physiotherapy session + non invasive ventilation not hemodynamically tolerated
- •Need for a session of non invasive ventilation + physiotherapy > 30 minutes.
结局指标
主要结局
Relative difference in PaO2/FiO2 ratio: (measurement after - measurement before the physiotherapy session + non invasive ventilation) / measurement before.)
时间窗: the morning after the heart surgery
The higher the ratio, better is the result. Between approximately 0 and 400
Difference in lung ultrasound score: measurement after - measurement before the physiotherapy session + non invasive ventilation
时间窗: the morning after the heart surgery
Lung ultrasound score = global measurement on 12 thoracic regions (6 per hemithorax: 2 anteriors, 2 laterals, 2 posteriors) to obtain a result out of 36 (sum of all values found in each zone). Each zone is evaluated as follows: 0 = normal ventilation 1. = multiple B-lines defined 2. = coalescing B-lines 3. = pulmonary consolidation
次要结局
- Lung ultrasound score values obtained by both evaluators from the same recorded ultrasound images. If there is a difference of one point between the two scores measured, a third reading by a doctor will be taken. This 3rd score will then be retained.(in the week following the measurements)
- relative difference in PaO2/FiO2 ratio(the morning after the heart surgery)
- difference in lung ultrasound score for each study area(the morning after the heart surgery)
- relative difference in PaCO2(the morning after the heart surgery and after physiotherapy session)
- initial lung ultrasound score(the morning after the heart surgery)
- For each subject, answers to two questions at the end of the session about his or her understanding of PAS after the information provided by the MK during the session(the morning after the heart surgery)
研究者
Aurelie OUDIN-ROTH
Principal Investigator
Central Hospital, Nancy, France