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HFNO 改善双腔气管插管肺部手术窒息期间的血氧饱和度

2026年11月12日 更新者:Shenzhen Second People's Hospital

经鼻高流量氧合改善双腔气管插管肺部手术窒息期间的血氧饱和度:一项随机对照研究

With the continuous strengthening of the concept of rapid rehabilitation, great progress has been made in minimally invasive thoracic surgery, and thoracoscopic surgery has developed rapidly. Double-lumen endotracheal(DLT) intubation is still the most reliable way of intubation in lung surgery. However, hypoxemia faced during double-lumen intubation still threatens the perioperative safety of thoracic surgery patients. In recent years, high-flow nasal oxygenation (HFNO) has great potential in the field of anesthesia, especially playing a new and important role in the prevention and treatment of short-term hypoxia and life-threatening airway emergencies. However, the use of HFNO in pulmonary surgery patients with poor pulmonary function lacks evidence-based basis, and there are few reliable clinical data.

This study adopted a prospective, randomized, controlled, single-blind design. A total of 100 patients aged 18-60 years who underwent elective thoracoscopy-assisted pulmonary surgery were included and randomly divided into the experimental group: HFNO was used in the process of double-lumen intubation asphyxia; the control group: according to the traditional intubation process, No oxygen therapy equipment was used during intubation asphyxiation. The lowest blood oxygen saturation during intubation, the incidence of hypoxemia during intubation, perioperative complications, and postoperative hospital stay were compared between the two groups.

This study explores the advantages of HFNO in complex endotracheal intubation, assuming that HFNO can improve the oxygen saturation of double-lumen intubation; optimize the intubation method of DLT, and tap its new potential to prevent and manage emergency airway crisis.

研究概览

地位

完全的

条件

干预/治疗

研究类型

介入性

注册 (实际的)

112

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Guangdong
      • Shenzhen、Guangdong、中国、518000
        • Shenzhen Second People's Hospital

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 60年 (成人)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Age 18-60;
  • Patients planning to undergo video-assisted thoracoscopic (VATS) lung surgery requiring DLT intubation;
  • Patients who agreed to participate in this study.

Exclusion Criteria:

  • American Society of Anesthesiologists (ASA) classification > IV;
  • Patients with severe nasal obstruction; expected difficult intubation or difficulty with mask ventilation;
  • Morbid obesity [Body Mass Index (BMI)>35kg/m2)];
  • Airway anatomical abnormalities;
  • Abnormal coagulation function;
  • Emergency surgery;
  • Patients at high risk of reflux aspiration, including ileus, full stomach, esophageal reflux disease;
  • Pregnant or breastfeeding women.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:三倍

武器和干预

参与者组/臂
干预/治疗
实验性的:HFNO group

Direct guidance and positioning of DLT intubation with FOB visualization, using HFNO during intubation asphyxia.

After the patient's mask-assisted ventilation makes the end-expiratory oxygen concentration (EtO2) > 90%, wear the HFNO device according to the pre-adjusted mode (temperature 34°C, oxygen concentration 100%, flow rate 50 litres per minute). The nasal cannula will remain in place until intubation is complete (including DLT intubation, direct FOB guidance, and DLT alignment with FOB). After securing the HFNO device, the glottis was exposed using a laryngoscope, and the DLT main tracheal cuff was passed through the glottis and paused under direct vision. Insert the DLT into the bronchial tube lumen of the DLT using the FOB, and then advance the DLT into the corresponding main bronchus under the guidance of the FOB. After confirming the appropriate depth of the catheter using the FOB, insert the DLT into the anesthesia machine to complete the intubation process. After the DLT was connected to the anesthesia machine and mechanical ventilation was started, the HFNO device was removed.

其他名称:
  • 高流量经鼻氧疗
无干预:Control group

The DLT cannula was directly guided and positioned under FOB visualization, and no oxygen therapy equipment was used during intubation.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Minimum blood oxygen saturation (SpO2)
大体时间:After the DLT intubation

Minimum SpO2 measured by capillary oximeter during DLT intubation. SpO2 was continuously monitored by the monitor every 1 second and recorded every 5 seconds, and the lowest SpO2 was recorded through the monitor by the recording personnel who were not involved in anesthesia management.

After the DLT intubation

次要结果测量

结果测量
措施说明
大体时间
The incidence of lowest SpO2<90%
大体时间:After the DLT intubation

Minimum SpO2 measured by capillary oximeter during DLT intubation. SpO2 was continuously monitored by the monitor every 1 second and recorded every 5 seconds, and the lowest SpO2 was recorded through the monitor by the recording personnel who were not involved in anesthesia management.

After the DLT intubation
The incidence of lowest SpO2<95%
大体时间:After the DLT intubation

Minimum SpO2 measured by capillary oximeter during DLT intubation. SpO2 was continuously monitored by the monitor every 1 second and recorded every 5 seconds, and the lowest SpO2 was recorded through the monitor by the recording personnel who were not involved in anesthesia management.

After the DLT intubation
DLT intubation time
大体时间:After the DLT intubation

The DLT intubation period was defined as: from the time the video laryngoscope was placed in the oral cavity, to the confirmation of the correct position of the DLT by the FOB, and the end of the insertion of the anesthesia machine.

After the DLT intubation
End-tidal carbon dioxide partial pressure after intubation
大体时间:After the DLT intubation

When the tracheal intubation is completed, the monitor displays the partial pressure of carbon dioxide at the end of the first mechanical ventilation.

After the DLT intubation
End-tidal oxygen concentration after intubation
大体时间:After the DLT intubation

When the tracheal intubation is completed, the monitor displays the end-expiratory oxygen concentration of the first mechanical ventilation.

After the DLT intubation
The incidence of difficult airway
大体时间:After the DLT intubation

Difficult airway was defined as failure of videolaryngoscope intubation, switch to fiberoptic bronchoscope-guided intubation.

After the DLT intubation
The incidence of bronchial dislocation
大体时间:After the DLT intubation

Left or right bronchial tube strayed into right or left bronchus.

After the DLT intubation
Incidence of related complications during intubation
大体时间:After the DLT intubation

Associated complications during intubation include: reflux aspiration, laryngospasm or bronchospasm, tracheal or bronchial tear, barotrauma, systolic blood pressure < 90 mmHg or initiation of vasoactive drugs, systolic blood pressure > 180 mmHg, severe arrhythmias, and lips or tooth damage.

After the DLT intubation
Operator satisfaction with intubation
大体时间:After the DLT intubation

Operator satisfaction rating for intubation (range 0-10, with 0 being very dissatisfied and 10 being very satisfied).

After the DLT intubation
The incidence of low blood oxygen saturation (SpO2<90%) in the post-anaesthesia care unit (PACU)
大体时间:Up to 1 week

After the patient entered the PACU, the blood oxygen saturation was continuously monitored and the lowest blood oxygen saturation value was recorded.

Up to 1 week
The incidence of postoperative airway-related complications
大体时间:1st, 2nd and 3rd day after surgery

Postoperative airway-related complications include: sore throat, hoarseness, and nasopharyngeal dryness.

1st, 2nd and 3rd day after surgery
The incidence of nausea and vomiting
大体时间:1st, 2nd and 3rd day after surgery

Interview patients' subjective feelings, including nausea and vomiting.

1st, 2nd and 3rd day after surgery
Patient satisfaction with anesthesia
大体时间:The first day after surgery

Patient satisfaction with anesthesia(range 0-10, with 0 being very dissatisfied and 10 being very satisfied).

The first day after surgery
Postoperative hospital stay
大体时间:Through study completion, an average of 4 weeks

The medical record system queries the number of days in hospital after surgery.

Through study completion, an average of 4 weeks
The incidence of postoperative complication
大体时间:Through study completion, an average of 4 weeks

Postoperative complications included postoperative atelectasis, pneumothorax, pulmonary infection, pleural effusion, bronchopleural fistula and postoperative bleeding.

Through study completion, an average of 4 weeks

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2023年3月20日

初级完成 (实际的)

2024年5月31日

研究完成 (实际的)

2024年5月31日

研究注册日期

首次提交

2022年9月21日

首先提交符合 QC 标准的

2022年12月23日

首次发布 (实际的)

2022年12月28日

研究记录更新

最后更新发布 (实际的)

2026年11月13日

上次提交的符合 QC 标准的更新

2026年11月12日

最后验证

2026年11月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

IPD 计划说明

The research protocol will be announced later in the plan.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

在美国制造并从美国出口的产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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