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临床试验/CTRI/2025/08/093164
CTRI/2025/08/093164尚未招募2 期

Comparison of mechanical power between PCV vs VCV in children undergoing laparoscopic surgery under general anesthesia.

AIIMS New Delhi1 个研究点 分布在 1 个国家目标入组 132 人开始时间: 2025年8月28日最近更新:

试验速览

阶段
2 期
状态
尚未招募
发起方
入组人数
132
试验地点
1
主要终点
calculation of mechanical power on volume control mode in group V and pressure control mode in group P, derived by measuring the following Respiratory mechanics parameters: Following parameters will be measured

研究概览

简要总结

Pressure-limited mode’s adaptability to compliance changes: PCV delivers breaths at a set pressure, adjusting the tidal volume based on the lung’s compliance. In laparoscopic surgeries where pneumoperitoneum affects compliance due to increased intra-abdominal pressure, PCV might result in lower mechanical power as it adapts to these compliance changes more dynamically than VCV.

Tidal volume variability: VCV delivers a set tidal volume regardless of changes in lung compliance, potentially leading to higher delivered tidal volumes in situations with decreased lung compliance (as in laparoscopic surgeries with pneumoperitoneum). This could result in increased mechanical power in VCV due to higher tidal volumes against less compliant lungs.

Peak airway pressures: In laparoscopic surgeries, increased intra-abdominal pressure from insufflation of carbon dioxide can increase peak airway pressures. PCV, by limiting pressure, might lead to lower peak airway pressures compared to VCV. Lower peak pressures might contribute to reduced lung injury risk and subsequently lower mechanical power in PCV.

Intrinsic PEEP: VCV might generate higher intrinsic Positive End-Expiratory Pressure (PEEP) due to its fixed tidal volume delivery, especially in conditions like laparoscopic surgeries where dynamic changes in compliance occur. This increased PEEP can contribute to higher mechanical power compared to PCV, which may have lower or more adjustable PEEP levels.

Optimal distribution of ventilation: PCV may facilitate better distribution of ventilation in conditions like laparoscopic surgeries where there might be compromised lung compliance due to altered positioning, such as Trendelenburg or reverse Trendelenburg positions. Improved ventilation distribution might reduce the need for higher pressures, thus lowering mechanical power.

Respiratory system mechanics and energy expenditure: By adapting to changes in lung compliance, PCV might be more efficient in reducing energy expenditure and mechanical work on the respiratory system compared to VCV, particularly in conditions of altered lung mechanics during laparoscopic surgery.

These rationales suggest that PCV might offer advantages in adapting to changing compliance, providing more stable pressures, and potentially reducing mechanical power compared to VCV in the context of laparoscopic surgeries in pediatric patients. However, empirical research through controlled trials or retrospective studies comparing these ventilation modes in this specific surgical setting is necessary to validate these hypotheses.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant Blinded

入排标准

年龄范围
1.00 Year(s) 至 12.00 Year(s)(—)
性别
All

入选标准

  • age between 1 years and 12 years 2)ASA status I to III 3)elective laparoscopic surgery with a duration exceeding 1 hour.

排除标准

  • Parental refusal to participate 2) History of severe cardiac and neurological diseases 3) History of severe lung disease (Pneumothorax, Pulmonary TB, Pleural effusion ) 4) children with known deformities of chest wall or thoracic spine.

结局指标

主要结局

calculation of mechanical power on volume control mode in group V and pressure control mode in group P, derived by measuring the following Respiratory mechanics parameters: Following parameters will be measured

时间窗: after induction of anesthesia, before pneumoperitoneum,15 minutes after pneumoperitoneum,just after deflation of pneumoperitoneum

Driving pressure ,Peak airway pressure

时间窗: after induction of anesthesia, before pneumoperitoneum,15 minutes after pneumoperitoneum,just after deflation of pneumoperitoneum

Mean airway pressure, Plateau pressure

时间窗: after induction of anesthesia, before pneumoperitoneum,15 minutes after pneumoperitoneum,just after deflation of pneumoperitoneum

Static Lung compliance

时间窗: after induction of anesthesia, before pneumoperitoneum,15 minutes after pneumoperitoneum,just after deflation of pneumoperitoneum

次要结局

  • 1)Blood pressure- systolic blood pressure & Diastolic blood pressure(2)oxygen saturation (spo2))

研究者

发起方
AIIMS New Delhi
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Nishant Patel

All India Institute of Medical Science

研究点 (1)

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