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临床试验/NCT07680881
NCT07680881已完成不适用

Volume-Controlled Versus VCV With AutoFlow Assessed by a Modified Lung Ultrasound Score and the Alveolar-Arterial Oxygen Gradient in Adults Undergoing Prone-Position Surgery: A Prospective Single-Centre Observational Study

Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2024年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
90
试验地点
1
主要终点
Postoperative modified lung ultrasound score

研究概览

简要总结

This prospective single-centre observational study compared two intraoperative mechanical ventilation modes, volume-controlled ventilation (VCV) and VCV with AutoFlow/AF, in adults undergoing elective surgery in the prone position. The ventilation mode was selected by the attending anaesthesiologist as part of routine clinical care; the investigators did not assign it. Perioperative atelectasis was assessed using a modified bilateral 12-zone lung ultrasound score obtained before induction of anaesthesia and after extubation, and oxygenation was assessed using the alveolar-arterial oxygen gradient calculated from an intraoperative arterial blood gas sample. The study also examined whether the effect of ventilation mode on atelectasis differed according to obesity.

详细描述

Ninety adults (American Society of Anesthesiologists physical status I-II, body mass index below 35 kg/m2, aged 18 to 65 years) scheduled for elective prone-position surgery were grouped by the ventilation strategy chosen by the attending anaesthesiologist: VCV (n=45) or VCV-AF (n=45). Both groups received a tidal volume of 6 to 8 mL/kg and median positive end-expiratory pressure of 5 cmH2O, delivered with a Draeger Perseus A500 anaesthesia workstation. A modified lung ultrasound score was obtained in the supine position using a 2 to 5 MHz convex probe before induction and at least 30 minutes after extubation, with each hemithorax divided into anterior, lateral and posterior regions and each region scored for loss of aeration. The alveolar-arterial oxygen gradient was calculated from an arterial blood gas sample taken 15 minutes after prone positioning. Patients were stratified by body mass index (below 30 versus 30 kg/m2 or above).

The primary comparison was the postoperative lung ultrasound score between the two ventilation modes. Pre-specified analyses included adjustment for the baseline lung ultrasound score using analysis of covariance and a formal ventilation-mode by obesity interaction test. The correlation between the lung ultrasound score and the alveolar-arterial oxygen gradient was also assessed. Of 97 patients initially enrolled, seven were excluded because postoperative lung ultrasound data could not be completed owing to unavailability of the ultrasound device or operator, leaving 90 patients with complete data for analysis.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

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

入选标准

  • Consented adults aged 18 to 65 years American Society of Anesthesiologists (ASA) physical status I or II Body mass index below 35 kg/m2 Scheduled for elective surgery in the prone position Oriented and cooperative

排除标准

  • No consent Pre-existing pulmonary disease Any perioperative lung pathology Inability to complete postoperative lung ultrasound assessment

研究组 & 干预措施

VCV

Patients managed intraoperatively with volume-controlled ventilation, as chosen by the attending anaesthesiologist.

结局指标

主要结局

Postoperative modified lung ultrasound score

时间窗: At least 30 minutes after extubation

Modified bilateral 12-zone lung ultrasound score assessed after surgery and compared between ventilation modes. Each hemithorax was divided into anterior, lateral and posterior regions, and each region was scored for loss of aeration, with a higher total score indicating greater atelectasis.

次要结局

  • Alveolar-arterial oxygen gradient(15 minutes after prone positioning)
  • Ventilation-mode by obesity interaction on postoperative lung ultrasound score(At least 30 minutes after extubation)

研究者

发起方
Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
申办方类型
Other
责任方
Principal Investigator
主要研究者

Taylan Kırdan

MD

Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization

研究点 (1)

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