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临床试验/NCT07758517
NCT07758517已完成不适用

Evaluation of the Association Between Fresh Gas Flow Rate During Inhalational Anesthesia and Perioperative Pulmonary Aeration Assessed Using the Lung Ultrasound Score in Patients Undergoing Septoplasty: A Prospective Observational Study

Fatih Sultan Mehmet Training and Research Hospital1 个研究点 分布在 1 个国家目标入组 2 人开始时间: 2024年1月10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
发起方
入组人数
2
试验地点
1
主要终点
Perioperative Change in Modified Lung Ultrasound Score

研究概览

简要总结

This prospective, single-center observational cohort study evaluated the association between fresh gas flow rate during inhalational anesthesia and perioperative changes in lung aeration in adults undergoing elective surgery for nasal septal deviation.

Participants were classified into two cohorts according to the fresh gas flow rate used during routine anesthesia care: 1 L/min or 3 L/min. The flow rate was selected independently by the attending anesthesiologist as part of routine clinical practice and was not assigned by the research protocol.

Lung aeration was assessed using the modified lung ultrasound score before anesthesia, after tracheal intubation, before extubation, 15 minutes after admission to the post-anesthesia care unit, and before discharge from the post-anesthesia care unit. Perioperative oxygenation, hemodynamic variables, respiratory mechanics, and early postoperative recovery findings were also recorded.

详细描述

This was a prospective, single-center observational cohort study conducted at Fatih Sultan Mehmet Training and Research Hospital. Adult patients aged 18 to 65 years with American Society of Anesthesiologists physical status I or II who underwent elective surgery for nasal septal deviation under general anesthesia were evaluated.

All participants provided written informed consent before enrollment. Anesthetic management was performed according to routine institutional clinical practice. The fresh gas flow rate was determined independently by the attending anesthesiologist and was not assigned or modified by the research protocol. Participants were subsequently classified into two observational cohorts according to the documented fresh gas flow rate used during inhalational anesthesia: 1 L/min or 3 L/min. No randomization was performed.

Lung ultrasound examinations were performed at five perioperative time points: before induction of anesthesia, after tracheal intubation, before extubation, 15 minutes after admission to the post-anesthesia care unit, and approximately 30 minutes after admission or immediately before discharge from the post-anesthesia care unit.

Lung aeration was evaluated in 12 thoracic regions using a modified lung ultrasound score. Each region was scored from 0 to 3 according to the observed ultrasound pattern. A score of 0 represented normal aeration, while scores of 1, 2, and 3 represented mild, moderate, and severe loss of aeration, respectively. The total score ranged from 0 to 36, with higher scores indicating greater loss of lung aeration.

The primary objective was to compare perioperative changes in the lung ultrasound score between patients receiving fresh gas flow rates of 1 L/min and 3 L/min during routine anesthesia. Additional recorded variables included heart rate, systolic, diastolic, and mean arterial pressure, peripheral oxygen saturation, perfusion index, end-tidal carbon dioxide, inspired and expired oxygen concentrations, body temperature, peak airway pressure, airway resistance, and dynamic lung compliance. Early postoperative findings, including pain intensity, nausea, vomiting, and shivering, were also evaluated in the post-anesthesia care unit.

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
否

入选标准

  • •Adults aged 18 to 65 years
  • •Scheduled to undergo elective septoplasty for nasal septal deviation under general anesthesia
  • •American Society of Anesthesiologists physical status I or II
  • •Body mass index of 35 kg/m² or less
  • •Provided written informed consent to participate

排除标准

  • •Acute respiratory tract infection within the preceding 15 days
  • •Chronic pulmonary disease
  • •Malignancy
  • •Significant hepatic, renal, or cardiac disease
  • •Limited ability to cooperate with the study assessments
  • •Cerebrovascular or neuromuscular disease
  • •Previous thoracic surgery
  • •Chest wall deformity
  • •Emergency surgery
  • •History of clinically relevant allergy

研究组 & 干预措施

1 L/min Fresh Gas Flow Cohort

Participants who received inhalational general anesthesia with a fresh gas flow rate of 1 L/min as part of routine anesthetic care. The fresh gas flow rate was selected independently by the attending anesthesiologist and was not assigned by the research protocol. Perioperative lung aeration was evaluated using the modified lung ultrasound score.

干预措施: Fresh Gas Flow Rate of 1 L/min (Other)

3 L/min Fresh Gas Flow Cohort

Participants who received inhalational general anesthesia with a fresh gas flow rate of 3 L/min as part of routine anesthetic care. The fresh gas flow rate was selected independently by the attending anesthesiologist and was not assigned by the research protocol. Perioperative lung aeration was evaluated using the modified lung ultrasound score.

干预措施: Fresh Gas Flow Rate of 3 L/min (Other)

结局指标

主要结局

Perioperative Change in Modified Lung Ultrasound Score

时间窗: Preoperative baseline; after tracheal intubation; before extubation; 15 minutes after PACU admission; and approximately 30 minutes after PACU admission or before PACU discharge

Lung aeration was assessed in 12 thoracic regions, six regions in each hemithorax. Each region was scored from 0 to 3: 0 indicated normal aeration, 1 mild loss of aeration, 2 moderate loss of aeration, and 3 severe loss of aeration or consolidation. Regional scores were summed to obtain a total modified lung ultrasound score ranging from 0 to 36. Higher scores indicated greater loss of lung aeration. Changes in the total score across the perioperative time points were compared between the 1 L/min and 3 L/min fresh gas flow cohorts.

次要结局

  • Perioperative Peripheral Oxygen Saturation(Preoperative baseline; after tracheal intubation; before extubation; 15 minutes after PACU admission; and approximately 30 minutes after PACU admission or before PACU discharge)
  • Intraoperative Dynamic Lung Compliance(Approximately 5 minutes after tracheal intubation and immediately before extubation)
  • Intraoperative Peak Airway Pressure(Approximately 5 minutes after tracheal intubation and immediately before extubation)
  • Intraoperative Airway Resistance(Approximately 5 minutes after tracheal intubation and immediately before extubation)
  • Postoperative Pain Intensity(At 15 minutes and approximately 30 minutes after admission to the PACU)
  • Incidence of Nausea, Vomiting, and Shivering in the PACU(From admission to the PACU until PACU discharge, approximately 30 minutes)

研究者

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

Oznur Demiroluk

Associate Professor of Anesthesiology and Reanimation

Fatih Sultan Mehmet Training and Research Hospital

研究点 (1)

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Fresh Gas Flow Rate and Perioperative Lung Aeration... | 临床试验