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Prevention of Gastric Insufflation During Positive Pressure Ventilation ?

2017年12月14日 更新者:Jean François Brichant、University of Liege

Is Ultrasound-guided Left Paratracheal Esophagus Pressure More Effective Than Cricoid Pressure to Prevent Gastric Insufflation During Positive Pressure Ventilation ?

Evaluation of a new method to prevent gastric insufflation

研究概览

地位

未知

详细说明

After Ethics Committee approval of the University of Liège and written informed consent, 90 ASA 1-2 patients aged 18-65 years and scheduled for elective surgery under general anesthesia will be enrolled in the study. Exclusion criteria are body mass index (BMI) above 35; meeting criteria for difficult ventilation and/or intubation, such as oropharyngeal pathology or facial or cervical abnormalities; and risk for aspiration or previous gastric surgery. Patients will be randomly allocated 1:1:1 (30 patients/group) by the method of sealed envelopes to left low paratracheal esophageal compression (LPEC), cricoid pressure (CP), or no pressure intervention (Control). Neck circumference will be measured. No premedication will be given prior to the study interventions.

Part 1: Ultrasound assessment of the esophagus at the left lower paratracheal level

Esophageal examinations will be conducted by ultrasound with the patient supine and head in neutral position. Feasibility of imaging and compressing the esophagus approximately 2-3 cm above the clavicle was assessed as follows:

A linear ultrasound probe (Applio XG iStyle Toshiba with a 14-7 Mhz) was positioned in a transverse (axial) orientation over the left paratracheal area (Figure 1(A)), 2-3 cm above the clavicle. The position of the esophagus in relation to the trachea (left, right or not seen) will be recorded. Once the esophagus will be identified, the antero-posterior diameter (mm) will be measured and compared before and after applying an estimated pressure of 30 N (as described below) or until a bony contact will be established with the transducer. Esophageal compression will be re-assessed using a paramedian sagittal plane between the trachea and the sternocleidomastoid muscle with the esophagus in sagittal plane. The antero-posterior diameter (mm) measurements will be repeated before and after applying pressure with the transducer. Three consecutive measures for each probe position were recorded.

Part 2: Assessment of the presence of gastric (antral) air With the patients in supine position, a curvilinear transducer (Applio XG iStyle Toshiba with an 8-5 MHz) will be placed on the epigastrium in a paramedian sagittal orientation to identify the antrum. 9 The cross-sectional area of the antrum was measured at the level where both the aorta and upper mesenteric artery were visible. Three consecutive measures were taken (a) before the induction of anesthesia and (b) after 3 min of PPV via face mask. The presence of gastric air insufflation is defined as an increase in cross-sectional area and/or presence of artifacts in the antrum (comet tail, posterior acoustic shadow). 9 These assessments will be performed by a sonographer, blinded to group allocation by a surgical drape placed between the thorax and the abdomen.

Pressure maneuvers Two anesthesiology residents, not informed of the study outcome measurements, will be trained to apply sustained pressure of 30 ± 5 N using an electronic dynamometer (MicroFET2; Hoogan Industries, West Jordan, Utah), until 10 consecutive maneuvers will be measured successfully (30 ± 5 N). For cricoid pressure, the cartilage will be compressed with the thumb and index fingers toward the vertebral bodies (Sellick). For LPEC, the thumb will be placed over the base of the neck on the left side of the trachea 2-3 cm above the clavicle and medial to the sternocleidomastoid muscle (Figure 1(B)).

ASA monitoring will be applied, and anesthesia will be induced with propofol 2.5 mg/kg administered over 45 sec. Remifentanil will be administered with an infusion pump (2 to 3 μg/kg over 60 sec during induction, followed by continuous infusion of 0.05μg /kg/min). After general anesthesia will be induced, PPV was accomplished with a face-mask in pressure-control mode while maintaining a positive inspiratory pressure of 25 cm H2O, (Zeus ventilator, Dräger, Lübeck, Germany). The ventilator settings will be 100% oxygen, I:E ratio 1:2, 15 breaths/min, no positive end-expiratory pressure. Adequacy of ventilation will be documented by chest raise and capnography. Antral measurements will be taken after 3 min of face-mask ventilation by a sonographer blinded to group assignment. Thereafter, the management of anesthesia care will be continued as per institutional standards.

研究类型

观察性的

注册 (预期的)

90

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Liege
      • Liège、Liege、比利时、4000
        • 招聘中
        • CHU de Liège
        • 接触:
        • 接触:

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 65年 (成人、年长者)

接受健康志愿者

不适用

有资格学习的性别

全部

取样方法

概率样本

研究人群

patients undergoing anesthesia under general anesthesia

描述

Inclusion Criteria:

  • elective surgery under general anesthesia

Exclusion Criteria:

  • body mass index above 35 meeting criteria for difficult ventilation and /or intubation risk for aspiration or gastric surgery

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

队列和干预

团体/队列
control,
control normal ventilation
sellick,
ventilation while sellick manoeuvre is applied
low paratracheal esophagus compression
ventilation while low paratracheal esophagus compression is applied

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
gastric volume
大体时间:within 10 min of induction of anesthesia
With the patients in supine position, a curvilinear transducer (Applio XG iStyle Toshiba with an 8-5 MHz) will be placed on the epigastrium in a paramedian sagittal orientation to identify the antrum. The cross-sectional area of the antrum will be measured at the level where both the aorta and upper mesenteric artery will be visible
within 10 min of induction of anesthesia

次要结果测量

结果测量
措施说明
大体时间
diameter of the esophagus
大体时间:within 10 min of induction of anesthesia
A linear ultrasound probe (Applio XG iStyle Toshiba with a 14-7 Mhz) will be positioned in a transverse (axial) orientation over the left paratracheal area (Figure 1(A)), 2-3 cm above the clavicle. The position of the esophagus in relation to the trachea (left, right or not seen) will be recorded. When the esophagus will be identified, the antero-posterior diameter (mm) will be measured and compared before and after applying an estimated pressure of 30 N.
within 10 min of induction of anesthesia

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2017年3月22日

初级完成 (预期的)

2018年2月1日

研究完成 (预期的)

2018年2月1日

研究注册日期

首次提交

2017年12月14日

首先提交符合 QC 标准的

2017年12月14日

首次发布 (实际的)

2017年12月20日

研究记录更新

最后更新发布 (实际的)

2017年12月20日

上次提交的符合 QC 标准的更新

2017年12月14日

最后验证

2017年12月1日

更多信息

与本研究相关的术语

其他研究编号

  • ULGANESGAU001

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

药物和器械信息、研究文件

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