跳至主要内容
临床试验/NCT06612125
NCT06612125招募中不适用

Comparison of Positive Pressure Ventilation Strategies in Young Children Undergoing Laparoscopic Inguinal Hernia Repair With Laryngeal Mask Airway: A Prospective Randomized Study

Beni-Suef University1 个研究点 分布在 1 个国家目标入组 78 人开始时间: 2024年10月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
78
试验地点
1
主要终点
Pplat

研究概览

简要总结

The most basic modes of mechanical ventilation are volume-controlled ventilation (VCV) and pressure-controlled ventilation (PCV). VCV guarantees a target volume of ventilation using a constant flow, but may lead to high peak airway pressure (Ppeak) during the gas insufflation . In PCV mode, on the other hand,

详细描述

The laryngeal mask airway (LMA) provides a useful alternative for airway management during general anaesthesia. Inflation of the LMA cuff produces a low-pressure seal around the larynx, enabling positive pressure ventilation (PPV). The use of LMA as an airway management technique is common in the pediatric anesthesia because of its less irritating effect on the airways due to its location in the upper larynx. Now, the use of laryngeal mask instead of tracheal intubation for airway management has been achieved in day surgery, therefore, how to perform a respiratory management with a laryngeal mask is particularly important. In addition, mechanical ventilation is also a commonly used method of airway management in clinical practice. the ventilator will deliver a constant pressure by decelerating the flow. However, the ventilation volume varies according to the patient's respiratory mechanics . Pressure-controlled ventilation-volume guaranteed (PCV-VG) combines the advantages of both VCV and PCV, which delivers a stable ventilation volume using a decelerating flow pattern.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Sequential
主要目的
Other
盲法
Single (Participant)

入排标准

年龄范围
1 Year 至 5 Years(Child)
性别
All
接受健康志愿者
是

入选标准

  • •age between 1 and 5 years.
  • •patient scheduled for laparoscopic inguinal hernia repair.
  • •American Society of Anesthesiologists classification of physical status of I-II.

排除标准

  • •cardiopulmonary disease.
  • •severe hepatorenal dysfunction.
  • •history of upper respiratory tract infection 2 weeks before the operation.
  • •overweight [more than 20% of standard body weight].
  • •neuromuscular disease.
  • •anticipated difficult airway.
  • •hiatus hernia or gastroesophageal reflux disease.

研究组 & 干预措施

vCV group

Active Comparator

Pediatric patients in the PCV group(n=30) received pressure-controlled ventilation. The initial parameters will be as follows: the peak inspiratory pressure (PIP) will set to provide a tidal volume of 7 ml/kg , respiratory rate will be 16 breaths/min, inspiratory to expiratory ratio was 1:2 with an upper limit of PIP of 20 cm H2O.

干预措施: volume controlled ventilation (Other)

PCV group

Active Comparator

Pediatric patients in the PCV group(n=30) received pressure-controlled ventilation. The initial parameters will be as follows: the peak inspiratory pressure (PIP) will set to provide a tidal volume of 7 ml/kg , respiratory rate will be 16 breaths/min, inspiratory to expiratory ratio was 1:2 with an upper limit of PIP of 20 cm H2O.

干预措施: pressure controlled ventilation (Other)

PCV-VG group

Active Comparator

Pediatric patients in the PCV-VG group (n=30)will be conducted with pressure-controlled volume-guaranteed ventilation, target tidal volume will set at 7 mL/kg, with a respiratory rate of 16 breaths/min and a respiratory ratio of 1:2.

干预措施: pressure controlled volume grantanteed ventilation (Other)

结局指标

主要结局

Pplat

时间窗: within one hour

plateau airway pressure

(PIP)

时间窗: within one hour

peak inspiratory pressure

(Cdyn)

时间窗: within one hour

pulmonary dynamic compliance

(RAW

时间窗: within one hour

airway resistance

VT

时间窗: within one hour

exhaled tidal volume

EtCO2

时间窗: within one hour

end-expiratory carbon dioxide

Vd/VT

时间窗: within one hour

physiologic dead space over tidal volume

次要结局

  • (MAP)(within one hour)
  • (HR)(within one hour)
  • postoperative respiratory adverse events(within 24 hour)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mariana Soliman

egypt benisuef

Beni-Suef University

研究点 (1)

Loading locations...

相似试验