跳至主要内容
临床试验/NCT07050979
NCT07050979已完成不适用

Goal-Directed Fluid Therapy Versus Conventional Fluid Therapy for Thoracoscopic Lobectomy in the ERAS Era: A Randomized Controlled Trial

Cukurova University1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2024年6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
已完成
入组人数
80
试验地点
1
主要终点
Change in PaO2/FiO2 Ratio During One-Lung Ventilation

研究概览

简要总结

The investigators aimed to examine the effect of goal-directed fluid therapy (GDFT) compared to conventional fluid therapy in thoracoscopic lobectomy surgery with ERAS protocol on intraoperative pulmonary oxygenation and 30-day patient outcomes including postoperative morbidity and mortality. The primary outcome measure of the study was the PaO2/FiO2 ratio (change in pulmonary oxygenation) during one-lung ventilation, and the secondary outcomes were postoperative morbidity, quality of recovery, 30-day re-admission, and mortality rate.

This randomized controlled study analyzed 80 adult patients who underwent thoracoscopic lobectomy surgery with the ERAS protocol. In addition to standard monitoring in the operating room, all participants underwent Pressure Recording Analytical Method (PRAM) monitoring with the help of intra-arterial pressure monitoring method. Participants were randomly assigned to GDFT and conventional fluid therapy groups. In the GDFT group, fluid, inotropic agent and/or vasopressor therapy was administered by targeting stroke volume variation (SVV) and cardiac index (CI). In the control group, fluid and/or vasopressor therapy was administered with the guidance of MAP 65-95 mmHg and urine output at least 0.5 mL/kg/hr. Intraoperative hemodynamic data, amount and types of fluid administered, inotropic and vasopressor agents were recorded. Vital signs, pulmonary, cardiac and other system morbidity, quality of recovery on days 1, 3 and 5 in the postoperative care unit and in the ward, and re-admission to hospital and mortality within 30 days were recorded.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Participant, Investigator, Outcomes Assessor)

盲法说明

The anesthesiologist responsible for intraoperative management was aware of the group assignments, but other members of the research team, other healthcare providers, and patients were unaware. Confidentiality of randomization to the investigators was maintained until the end of the study for statistical data analysis.

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Age 18-65 years.
  • •ASA Physical Status Classification I-II.
  • •Undergoing elective thoracoscopic lobectomy with the ERAS protocol.
  • •Provided informed consent.

排除标准

  • •Age < 18 or > 65 years.
  • •ASA Physical Status Classification III or higher.
  • •Patients not in sinus rhythm, and with recent oral beta-blocker use.
  • •Patients with cardiac/renal/hepatic insufficiency, valvular heart disease (aortic or mitral valve insufficiency or stenosis)
  • •Patients with abnormal preoperative lung function (forced expiratory volume in 1 second less than 50% of predicted values)
  • •Patients with severe obesity (BMI>35 kg/m2)
  • •Patients who cannot be applied to the ERAS protocol
  • •Emergency surgery.
  • •Refusal to provide informed consent.

研究组 & 干预措施

Goal-Directed Fluid Therapy (GDFT)

Experimental

Patients receive intraoperative fluid and vasopressor therapy guided by Stroke Volume Variation (SVV < 15%) and Cardiac Index (CI > 2.6 L/min/m²) using the Pressure Recording Analytical Method (PRAM). Basal fluid replacement is provided with 5 mL/kg/hour Lactated Ringer's solution.

干预措施: Goal-Directed Fluid Therapy (GDFT) (Other)

Conventional Fluid Therapy

Active Comparator

Patients receive intraoperative fluid and vasopressor therapy targeting Mean Arterial Pressure (MAP) of 65-95 mmHg and minimum hourly urine output of 0.5 mL/kg/hour. Basal fluid replacement is provided with 5 mL/kg/hour Lactated Ringer's solution.

干预措施: Conventional Fluid Therapy (Other)

结局指标

主要结局

Change in PaO2/FiO2 Ratio During One-Lung Ventilation

时间窗: Intraoperative period (from anesthesia induction to extubation).

Measurement of PaO2/FiO2 ratio at five time points intraoperatively to assess pulmonary oxygenation.

次要结局

  • Mortality Rate(Postoperative 30th day.)
  • Postoperative Pulmonary Complications(Up to postoperative day 5.)
  • Postoperative Cardiac Complications(Up to postoperative day 5.)
  • Postoperative Infectious Complications(Up to postoperative day 5.)
  • Postoperative Renal Complications(Up to postoperative day 5.)
  • Quality of Recovery (QoR-15 Score)(Postoperative 24th hour.)
  • Length of Hospital Stay(From date of surgery until the date of discharge.)
  • 30-Day Hospital Readmission Rate(From date of discharge until the postoperative 30th day.)

研究者

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

Demet Laflı Tunay

Associate Professor

Cukurova University

研究点 (1)

Loading locations...

相似试验