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临床试验/NCT06203665
NCT06203665已完成不适用

Restoration of Pulmonary Compliance After Laparoscopic Gynaecologic Surgery Using a Recruitment Maneuver

Panagiota Griva2 个研究点 分布在 1 个国家目标入组 31 人开始时间: 2023年6月7日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
31
试验地点
2
主要终点
Delta (Δ) Compliance (T1 -T8)

研究概览

简要总结

To investigate the hypothesis that an alveolar recruitment maneuver after the release of pneumoperitoneum would restore the lung compliance to the baseline values after a laparoscopic gynaecologic surgery.

详细描述

In recent years, laparoscopic surgery is a common minimal invasive technique which ensures the avoidance of prolong hospital stay, long duration surgery, postoperative pain, operation scars. However, laparoscopic surgery has a negative impact on respiratory mechanics because of the pneumoperitoneum, the changes in position and the appliance of positive pressure ventilation. The increase in abdominal pressure as a result of carbon dioxide insufflation and the typical head-down body position have been shown to impair respiratory function. Application of a pneumoperitoneum-induced elevation of intraabdominal pressure elevates the diaphragm and results in a compression of the dependent ventral lung regions. As a consequence, the amount of atelectasis is increased. The insufflation of CO2 reduced respiratory system compliance, and increased peak inspiratory and mean airway pressures. Additionally, changes to the lithotomy and Trendelenburg position during gynaecologic surgery reduce lung compliance by altering the location of intestinal contents and diaphragm. Especially the Trendelenburg position potentiates the effects of abdominal pressure via gravity and relaxation of the diaphragm; thereby, increasing the airway pressure and reducing the functional residual capacity, which results in further changes in the respiratory system. Therefore, we evaluated the effect of an alveolar recruitment maneuver during gynaecologic laparoscopic surgery by determining the changes in lung compliance.

Design: Prospective study. Setting: Operating room of a hospital. Patients: 31 ASA physical status I and II patients scheduled to undergo gynaecologic laparoscopic surgery in the dorsal lithotomy position.

Interventions: The surgery would be performed under general anaesthesia according to the common practice using protective lung ventilation ( Vt= 6 ml /Kg ideal body weight , RR to maintain end-expiratory CO2 35-45 cmH2O and PEEP= 6- 8 cm H20). An incremental and decremental positive end-expiratory pressure alveolar recruitment maneuver would be performed after release of pneumoperitoneum.

Measurements: Respiratory mechanics including dynamic compliance were measured continuously. Respiratory measures were recorded together with arterial blood gases after induction (T1), with the patient placed in the dorsal lithotomy position (T2), 10 and 90 minutes after CO2 insufflation (T3 and T4), immediately after desufflation in the lithotomy and supine positions (T5 and T6), and 10 minutes after a pulmonary recruitment maneuver at the conclusion of surgery (T7).

Inclusion criteria:

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
Female
接受健康志愿者

入选标准

  • >18 years old patients
  • A gynaecologic laparoscopic surgery would be performed
  • Duration of the surgery over 90 minutes

排除标准

  • Chronic Obstructive Lung Disease with FEV1 < 60 of predicted value
  • Lung Emphysema
  • BMI > 30
  • Hemodynamic instability during the operation
  • Acute cor pulmonle

研究组 & 干预措施

Patients enrolled in the protocol

Experimental

An alveolar recruitment nameuver will be performed after the release of pneumoperitoneum

干预措施: Recruitment Maneuver (Diagnostic Test)

结局指标

主要结局

Delta (Δ) Compliance (T1 -T8)

时间窗: intraoperative, after anesthesia induction and after the recruitment maneuver

The compliance difference between T1 and T8, where T8 is the time of the recruitment maneuver.

Delta (Δ) Compliance (T7 -T8)

时间窗: intraoperative, after the release of pneumoperitoneum and after the recruitment maneuver

The different compliance between T7 and T8

Delta (Δ) Compliance (T1 -T7)

时间窗: intraoperative, after anesthesia induction and after the release of pneumoperitoneum

The compliance difference between T1 and T7, where T1 denotes the time of induction to anaesthesia and T7 is the release of pneumoperitoneum time.

次要结局

  • Compliance (in mL/cmH2O)(intraoperative (T1-T8))
  • Pplateau (in cmH2O)(intraoperative (T1-T8))
  • MAP (in mmHg)(intraoperative (T1-T8))
  • Intraoperative administration of vasoactive agents(intraoperative, after alveolar recruitment maneuver)

研究者

发起方
Panagiota Griva
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Panagiota Griva

Resident Doctor

National and Kapodistrian University of Athens

研究点 (2)

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