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临床试验/NCT06274372
NCT06274372已完成不适用

The Effect of Flow-controlled Ventilation on Hemodynamic and Respiratory Parameters in Laparoscopic Surgeries, Prospective Randomized Study

Derince Training and Research Hospital2 个研究点 分布在 2 个国家目标入组 30 人开始时间: 2023年8月7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
30
试验地点
2
主要终点
effects of flow controlled ventilation on arterial pressure

研究概览

简要总结

It is aimed to investigate the effect of flow controlled ventilation on intraoperative respiratory parameters and hemodynamic parameters in laparoscopic operations.

详细描述

Study will begin after ethics committee approval and the patient's written and verbal consent .

Prospective observational studies will be conducted on patients over the age of 18 who will undergo laparoscopic surgery in the operating rooms. Patients who did not give verbal and written consent, emergency interventions, patients at risk of aspiration, patients with an ASA physical status above 3 and a diagnosis of COPD will be excluded.

Patients will be randomized and divided into two groups. Patients intraoperatively ventilated with a conventional ventilator (GE™ Avance™ CS2, VCV mode) Group 1, intraoperative ventilation Ventinova ( Evone®, Ventinova Medical, Eindhoven, the Netherlands, FCV mode) will be referred to as Group 2. Standard monitoring (ECG; SpO2, end tidal CO2,arterial blood pressure) will be applied to all patients. Anesthesia induction will be performed with propofol, fentanyl, rocuronium bromide as standard; In addition, anesthesia maintenance of the patients will be provided with propofol and remifentanil.

Respiratory parameters such as peripheral SpO2, PaCO2 value, peak airway pressure of each group will be recorded, and intraoperative hemodynamic parameters (systolic, diastolic, mean blood pressure, heart rate) of each group will be monitored and recorded.

Postoperative respiratory functions and length of hospital stay of all patients will be monitored and recorded.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Single (Participant)

入排标准

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

入选标准

  • patients who will undergo laparoscopic surgeries, ASA 1,2,3 physical status

排除标准

  • patients who do not give verbal and written consent, emergency interventions, patients at risk of aspiration, patients with an ASA physical status above 3 and a diagnosis of COPD

结局指标

主要结局

effects of flow controlled ventilation on arterial pressure

时间窗: intraoperatively

Arterial blood pressure in mmHg

effectcs of flow controlled ventiletion on endtidal CO2

时间窗: intraoperatively

endtidal CO2 in mmHg

effects of flow controlled ventilation on mean arterial pressure

时间窗: intraoperatively

mean arterial pressure change in percent

effectcs of flow controlled ventiletion on peak airway pressure

时间窗: intraoperatively

peak airway pressure in cmH2O

effects of flow controlled ventilation on heart rate

时间窗: intraoperatively

heart rate in bpm

次要结局

  • respiratory related complications(intraoperative period and postoperative first week)

研究者

发起方
Derince Training and Research Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Nurseda Dundar

Principal Investigator

Derince Training and Research Hospital

研究点 (2)

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