Lung Ultrasound Assessment of Postoperative Atelectasis After Mechanical Ventilation With Minimum Driving Pressure
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Lung Ultrasound Score (LUS)
研究概览
简要总结
Brief summary The goal of this clinical trial is to compare two different types of perioperative mechanical ventilation (MV), specifically Protective Mechanical Ventilation (PMV) and MV with the lowest possible Driving Pressure (ΔP), in relation to the appearance of postoperative lung closing, eg atelectasis, in adult patients who are operated. Atelectasis will be evaluated via lung ultrasound.
The main questions it aims to answer are:
- Is MV with lower ΔP better than conventional PMV in keeping lungs more open perioperatively and immediately postoperatively?
- Does MV with lower ΔP decrease hospital stay, Intensive Care Unit (ICU) need and mortality?
Researchers will use lung ultrasound to compare MV with the lowest possible Driving Pressure (ΔP) to Protective Mechanical Ventilation (PMV) to see if any of this is more protective than the other concerning lung atelectasis.
All participants will receive perioperative MV.
Half of them will receive conventional Protective Mechanical Ventilation (PMV). This will include well known generally protective settings for mechanical ventilation of patients, concerning volumes, pressures, respiratory rate, inspiratory gases and ventilation maneuvers.
The rest of participants will be ventilated with the lowest possible Driving Pressure (ΔP). This will be similar to PMV in the chosen volumes, respiratory rate, inspiratory gases and ventilation maneuvers. However, the pressure inside lung at the end of expiration, eg Positive End Expiratory Pressure (PEEP), will be not be preset for every patient. Initially, we will perform a maneuver that will quantify each individual's lung characteristics and mechanics. According to this, we will find the exact PEEP that seems to suit each patients lungs most, and use this perioperatively, trying to provide lungs the best conditions every time.
After the completion of the operation, all the patients will be screened for atelectasis, via lung ultrasound, using a well established protocol for the quantification of atelectasis. The results will be statistically analyzed trying to find if any of the forementioned strategies of mechanical ventilation surpasses the other concerning atelectasis appearance.
Furthermore efficiency of lung oxygen absorption, hospital stay, ICU need and mortality will be noted.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •>17 years old
- •Surgery with general anesthesia & invasive mechanical ventilation
- •ASA score I-III
排除标准
- •<18 years old
- •Preoperative ARISCAT score estimation <26
- •Women during pregnancy or just given birth
- •Other type of anesthesia (Not general)
- •Contraindication of administration of neuromuscular blockade agents.
- •Contraindication of cease of spontaneous ventilation.
- •Mechanical ventilation without endotracheal intubation.
- •Severe heart failure / History of ischemic heart disease.
- •Moderate or severe chronic obstructive lung disease or interstitial lung disease.
- •History of operation in heart, lung or diaphragm.
- •Presence of new active pathology in respiratory system at the beginning of surgery (infection / trauma / anatomic disorder).
- •Severe intraoperative respiratory complication (laryngospasm / bronchospasm / anaphylaxis).
- •Immediate postoperative need for continuation of IMV.
- •Patient denial of participation in the trial.
研究组 & 干预措施
Lung Protective Ventilation
CONVENTIONAL LUNG PROTECTIVE VENTILATION
This group is mechanically ventilated with Invasive Mechanical Ventilation with PEEP 8 cm H20 Tidal Volume (VT) 8 ml/kg Ideal Body Weight (IBW) Respiratory Rate (RR) --> PaCO2 = 35-45 mmHg Inspired Oxygen Fraction (FiO2) 0.4 - 0.5 --> Pulse Saturation Oxygen (SpO2) > 93% Recruitment Maneuver (as described) every hour
干预措施: Lung Protective Ventilation (Procedure)
Minimum Driving Pressure
This group is mechanically ventilated with Invasive Mechanical Ventilation with PEEP; Initially 8 cm H20, titrated at level with Minimum Driving Pressure after first recruitment - titration maneuver followed by new recruitment maneuver VT 8 ml/kg IBW RR --> PaCO2 = 35-45 mmHg FiO2 0.4 - 0.5 --> SpO2 > 93% Recruitment Maneuver (as described) every hour
干预措施: PEEP titration for Minimum Driving Pressure (Procedure)
结局指标
主要结局
Lung Ultrasound Score (LUS)
时间窗: Within 20 minutes in PACU.
12 Position Lung Ultrasound will be performed in Post Anesthesia Care Unit (PACU) within 20 minutes postoperatively. In each position the potential scores will be 0,1,2 and 3. 0 --\> 0-2 B-lines 1. --\> \>2 B-lines or presence of small sublpleural consolidations with normal pleural line. 2. --\> Multiple coalescent B-lines or multiple small sublpleural consolidations with thickened or irregular pleural line. 3. --\> Total air loss or subpleural consolidation with diameter bigger than 1x2cm. The total sum of ultrasound scores of each position is marked as LUS.
次要结局
- Rate of NIMV need(Period of stay in Post Anesthesia Care Unit (PACU). From time of postoperative transfer to PACU until time of discharge from PACU and return to general clinic, an average of 1 hour.)
- Hospital Stay(From day of operation until the end of patient stay inside hospital, because of return to home or due to death.)
- ICU need.(From day of operation until the end of patient stay inside hospital, because of return to home or due to death.)
- ICU stay(From day of operation until the end of patient stay inside hospital, because of return to home or due to death.)
- 28 Day mortality(From day of operation until up to 28 days.)
- Mechanical Power (MP)(From the moment of beginning of operation until the moment of the end of operation and mechanical ventilation)
- Volume-normalized Mechanical Power (MPcrs)(From the moment of beginning of operation until the moment of the end of operation and mechanical ventilation)
- Elastic Power (EP)(From the moment of beginning of operation until the moment of the end of operation and mechanical ventilation)
- Volume-normalized Elastic Power (EPcrs)(From the moment of beginning of operation until the moment of the end of operation and mechanical ventilation)
- Rate of Postoperative Respiratory Failure(Within 30 minutes in PACU)
研究者
Antonios Kostouros
Anesthesiology Resident, Antonios Kostouros
University General Hospital of Patras