Influence of the End-inspiratory Pause on Mechanical Ventilation and Its Correlation With Electrical Impedance Tomography
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Changes in Respiratory System Compliance (ml/cmH2O)
研究概览
简要总结
This study evaluates the influence of two different end-inspiratory pause (EIP) times on respiratory mechanics and arterial gases of surgical patients when ventilated under an open lung approach (OLA) strategy. The investigators evaluate the impact of using EIP 10% versus 30% of the inspiratory time on a volume control model. The investigators also analyse the potential influence of these EIP on pulmonary gas distribution measured by electric impedance tomography.
详细描述
Prolonging the EIP while maintaining an adequate expiratory time has shown benefits in terms of improving alveolar effective ventilation and enhancing gas exchange in surgical and intensive care patients. However, there are no published studies addressing the effects of different EIP times on the respiratory mechanics and gas distribution of surgical patients when associated with OLA strategies for ventilation.
Assuming the benefits of OLA, these investigators hypothesized about the potential effects of increasing the EIP when ventilating patients in a volume control mode. In the present study the investigators evaluated the influence of two different EIP (10% and 30% of the inspiratory time) on the respiratory mechanics of patients submitted to scheduled abdominal surgery under general anesthesia and ventilated with a protective lung strategy. The investigators studied the influence of EIP on driving pressure (Pdriv), plateau pressure (Pplat), respiratory static compliance (Crs) and open lung PEEP (OL-PEEP). We also assessed gas distribution by means of electric impedance tomography and studied its influence on gas exchange measured by means of serial gasometries.
Study protocol. A forced spirometry was performed in all patients after accepting their inclusion.
On the day of surgery, standard monitoring was initiated on arrival in the theatre, including electrocardiography, pulse oximetry, and noninvasive blood pressure monitoring. After light sedation with 1-2 mg of midazolam, a thoracic epidural catheter was placed under local anesthesia on anesthesiologist's criteria. A remifentanil infusion 0.03 mcg/kg/min was started before left radial artery catheterization under local anesthesia. After recording basal data during full consciousness on 21% inspired oxygen, all participants were preoxygenated via a facial mask for 5 min on spontaneous ventilation with fraction of inspired oxygen (FiO2) of 0.7 and fresh gas flow of 6 L/min. After induction with propofol ((1-1.5 mg/kg of predicted body weight (PBW)), 0.8 mg/kg of PBW of rocuronium were administered and proceeded with tracheal intubation. Patients were ventilated via a Primus (Drager, Telford, PA, USA) using a tidal volume of 7 ml/kg of PBW; volume control mode comprised an inspiration: expiration ratio of 1:2 and a respiratory rate of 12-14 breaths per minute to maintain the etCO2 at 35-40 mmHg, with an initial PEEP of 5 cmH2O. EIP was programmed according to randomization group. Fresh gas flow of 2 L/min with FiO2 of 0.7 was used throughout the procedure. Anesthesia was maintained with remifentanil 0.03-0.1 mcg/kg/min and sevoflurane, with minimal alveolar concentration (MAC) of 0.7-1 adjusted for patient´s age. Bispectral Index monitoring was used throughout the entire procedure (BIS Quatro, Covidien Ilc, Mansfield, MA, USA). All ventilation parameters remained stable throughout the study except the EIP (diverted in function of study protocol assignation) and the PEEP, which was tailored according the principles of OLA ventilation previously published. A central venous line was inserted in all cases and continuous cardiac output monitoring, systemic vascular resistance and systolic volume variation were monitored throught out all procedure by means of FloTrac sensor (Edwards Lifesciences, Irvine, California, USA). Other monitoring included train of four (TOF) for neuromuscular relaxation.
Dräger Primus (Dräger Medical, Lübeck, Germany) was used for ventilation with continuous monitoring of peak pressure (Ppk), Pplat, PEEP, Crs, FiO2, fraction of expired oxygen (FeO2), end-tidal CO2 (etCO2). For blood gases an ABL90 FLEX PLUS analyzer (Radiometer Medical, Copenhagen, Denmark) was used. If hemodynamic instability occurred during the ARM (fall> 20% of the cardiac index or mean arterial pressure), maneuver was discontinued and ephedrine or phenylephrine was administered and registered, restoring ARM on haemodynamics recovering.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 99 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients older than 18 years proposed for major abdominal surgery under general anesthesia.
- •Written informed consent.
排除标准
- •Participation in another interventional study
- •American Society of Anesthesiologists (ASA) classification grade = IV
- •Patient in dialysis
- •Chronic obstructive pulmonary disease (COPD) grade GOLD (Global Initiative for Chronic Obstructive Lung Disease) > 2
- •Functional vital capacity < 60% or > 120% of the predicted
- •Body mass index (BMI) > 35 kg/m2
- •Relation PaO2/FiO2 <200 mmHg in the baseline sample
- •Presence of mechanical ventilation in the 72 hours prior to enrollment
- •New York Heart Association (NYHA) functional class ≥ 3
- •Clinically suspected heart failure
- •Cardiac Index (IC) < 2.5 ml/min/m2 and/or inotropics prior to surgery
- •Diagnosis or suspicion of intracranial hypertension
- •Presence of pneumothorax or giant bullae on preoperative imaging tests
- •Use of Continuous Positive Airway Pressure (CPAP).
研究组 & 干预措施
End-inspiratory pause (EIP) 10%
Once the patient is intubated and after initiating ventilation in a volume control mode using a tidal volume of 7 ml/kg of predicted body weight (PBW) with an inspiration: expiration ratio of 1:2; a respiratory rate of 12-14 breaths per minute to maintain the etCO2 at 35-40 mmHg and an initial PEEP of 5 cmH2O, the investigators will apply an alveolar recruitment maneuver (ARM) with estimation of the open lung PEEP using an end-inspiratory pause (EIP) corresponding with a of 10% of the total inspiratory time. Volume control ventilation will be restored after ARM maintaining the same ventilatory parameters except the EIP, which in this group will be of 10% of total inspiratory time.
干预措施: End-inspiratory pause 10% (Procedure)
End-inspiratory pause (EIP) 30%
Once the patient is intubated and after initiating ventilation in a volume control mode using a tidal volume of 7 ml/kg of predicted body weight (PBW) with an inspiration: expiration ratio of 1:2; a respiratory rate of 12-14 breaths per minute to maintain the etCO2 at 35-40 mmHg and an initial PEEP of 5 cmH2O, the investigators will apply an alveolar recruitment maneuver (ARM) with estimation of the open lung PEEP using an end-inspiratory pause (EIP) corresponding with a 30 % of the total inspiratory time. Volume control ventilation will be restored after ARM maintaining the same ventilatory parameters except the EIP, which in this group will be of 30 % of total inspiratory time.
干预措施: End-inspiratory pause 30% (Procedure)
结局指标
主要结局
Changes in Respiratory System Compliance (ml/cmH2O)
时间窗: Moment 0 (M0): 5 minutes (min) after tracheal intubation, with volume control and PEEP of 5 cmH2O; M1: 5 min after alveolar recruitment maneuver (ARM); M2: 5 min after crossing time of EIP; M3: 5 min after new ARM; M4: 5 min after crossing time EIP
Measurement of the respiratory system compliance (Crs; ml/cmH2O) when using an EIP of 10% versus 30% of the global inspiratory time.
次要结局
- Changes in Driving Pressure (Pdriv; cmH2O)(Moment 0 (M0): 5 minutes (min) after tracheal intubation, with volume control and PEEP of 5 cmH2O; M1: 5 min after alveolar recruitment maneuver (ARM); M2: 5 min after crossing time of EIP; M3: 5 min after new ARM; M4: 5 min after crossing time EIP)
