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临床试验/NCT07709039
NCT07709039进行中(未招募)不适用

"Comparison of the Effects of Volume-Controlled Ventilation and Pressure-Controlled Ventilation Modes on Compliance and End-Tidal CO2 In Patients Undergoing Laparoscopic Cholecystectomy"

Mehreen Mirza1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2026年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
60
试验地点
1
主要终点
Static Lung Compliance

研究概览

简要总结

This randomized controlled trial compares volume-controlled ventilation (VCV) and pressure-controlled ventilation (PCV) in adult patients undergoing elective laparoscopic cholecystectomy under general anesthesia. The study evaluates the effects of both ventilation modes on static lung compliance and end-tidal carbon dioxide (EtCO₂) at predefined intraoperative time points. The objective is to determine whether pressure-controlled ventilation provides improved respiratory mechanics and more effective ventilation compared with volume-controlled ventilation during laparoscopic surgery.

详细描述

Laparoscopic cholecystectomy is one of the most commonly performed surgical procedures under general anesthesia. Creation of carbon dioxide pneumoperitoneum during laparoscopic surgery increases intra-abdominal pressure, resulting in reduced functional residual capacity, decreased lung compliance, increased airway pressures, and alterations in carbon dioxide elimination. These physiological changes may impair respiratory mechanics and increase the risk of perioperative pulmonary complications. Therefore, selection of an appropriate mechanical ventilation strategy is essential to maintain adequate ventilation and optimize respiratory function during laparoscopic surgery. The objective of this randomized controlled trial is to compare the effects of volume-controlled ventilation and pressure-controlled ventilation on static lung compliance and end-tidal carbon dioxide (EtCO₂) in adult patients undergoing elective laparoscopic cholecystectomy under general anesthesia. The study aims to determine whether pressure-controlled ventilation provides superior intraoperative respiratory mechanics compared with volume-controlled ventilation while maintaining adequate ventilation throughout the surgical procedure.

This is a prospective, single-center, randomized controlled trial conducted in the Department of Anaesthesia, Nishtar Hospital, Multan. A total of 60 adult patients aged 25-50 years, of either sex, classified as American Society of Anesthesiologists (ASA) physical status I or II and scheduled for elective laparoscopic cholecystectomy, will be enrolled after obtaining written informed consent. Patients with uncontrolled cardiopulmonary disease, diabetes mellitus, significant renal or hepatic impairment, chronic systemic illness, body mass index below 18.5 kg/m² or above 24.9 kg/m², or recent respiratory tract infection within the preceding three weeks will be excluded.

Participants will be allocated in a 1:1 ratio using computer-generated randomization by an independent third party into one of two study groups. Group A will receive volume-controlled ventilation, while Group B will receive pressure-controlled ventilation. Allocation concealment will be maintained until initiation of mechanical ventilation. Baseline demographic variables including age, sex, and body mass index will be recorded before induction of anesthesia.

A standardized anesthetic technique will be used for all participants. Mechanical ventilation settings will include a tidal volume of 8 mL/kg (with inspiratory pressure adjusted in the PCV group to achieve the target tidal volume), respiratory rate initially set at 12 breaths per minute and subsequently adjusted to maintain an end-tidal carbon dioxide concentration between 32 and 38 mmHg, inspiratory-to-expiratory ratio of 1:2, fraction of inspired oxygen (FiO₂) of 0.40, positive end-expiratory pressure (PEEP) of 5 cmH₂O, and oxygen saturation maintained above 95%. Carbon dioxide pneumoperitoneum will be maintained with an intra-abdominal pressure of 12-15 mmHg throughout the procedure.

Static lung compliance and end-tidal carbon dioxide will be recorded at three predefined intraoperative time points: five minutes after induction of anesthesia, fifteen minutes after carbon dioxide insufflation in the reverse Trendelenburg position, and ten minutes after carbon dioxide desufflation. Measurements will be recorded using the integrated monitoring systems of the anesthesia workstation by a trained anesthesiologist who is not involved in group allocation. Blinding of the anesthesia provider is not feasible because of the nature of the interventions; however, the primary outcome measures are objective monitor-derived variables, minimizing the risk of measurement bias.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Double (Participant, Outcomes Assessor)

盲法说明

Participants are unaware of the assigned ventilation mode. Outcome measurements are objective monitor-derived parameters recorded using the anesthesia workstation, minimizing measurement bias. Care providers are not blinded because of the nature of the intervention.

入排标准

年龄范围
25 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Adult patients aged 25-50 years.
  • Either sex.
  • ASA physical status I or II.
  • Scheduled for elective laparoscopic cholecystectomy under general anaesthesia.
  • Written informed consent obtained.

排除标准

  • ASA physical status III or IV.
  • Body mass index (BMI) greater than 35 kg/m².
  • Significant pulmonary disease (e.g., COPD, asthma, restrictive lung disease).
  • Significant cardiovascular disease.
  • Pregnancy.
  • Previous upper abdominal surgery.
  • Conversion to open cholecystectomy.
  • Refusal to participate.

结局指标

主要结局

Static Lung Compliance

时间窗: Measured at three intraoperative time points: 5 minutes after induction of anesthesia, 15 minutes after carbon dioxide pneumoperitoneum in the reverse Trendelenburg position, and 10 minutes after carbon dioxide desufflation.

Comparison of static lung compliance between the volume-controlled ventilation (VCV) and pressure-controlled ventilation (PCV) groups during elective laparoscopic cholecystectomy under general anesthesia.

End-Tidal Carbon Dioxide (EtCO₂)

时间窗: Measured at three intraoperative time points: 5 minutes after induction of anesthesia, 15 minutes after carbon dioxide pneumoperitoneum in the reverse Trendelenburg position, and 10 minutes after carbon dioxide desufflation.

Comparison of end-tidal carbon dioxide (EtCO₂) levels between the VCV and PCV groups.

次要结局

  • Peak Inspiratory Pressure(Measured at three intraoperative time points: 5 minutes after induction of anesthesia, 15 minutes after carbon dioxide pneumoperitoneum in the reverse Trendelenburg position, and 10 minutes after carbon dioxide desufflation.)

研究者

发起方
Mehreen Mirza
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Mehreen Mirza

Postgraduate Resident, Department of Anaesthesia & Intensive Care, Nishtar Medical University and Hospital, Multan

Nishtar Medical University

研究点 (1)

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