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HFNO, 이중 루멘 기관내 삽관으로 폐 수술 중 질식 중 혈중 산소 포화도 개선

2026년 11월 12일 업데이트: Shenzhen Second People's Hospital

고유량 비강 산소화는 이중 내강 기관내 삽관으로 폐 수술 중 질식 중 혈중 산소 포화도를 개선합니다: 무작위 통제 연구

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.

연구 개요

상태

완전한

개입 / 치료

연구 유형

중재적

등록 (실제)

112

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

    • Guangdong
      • Shenzhen, Guangdong, 중국, 518000
        • Shenzhen Second People's Hospital

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 (성인)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 삼루타

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: 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.

다른 이름들:
  • 고유량 비강 산소 요법
간섭 없음: Control group

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

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Minimum blood oxygen saturation (SpO2)
기간: 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

2차 결과 측정

결과 측정
측정값 설명
기간
The incidence of lowest SpO2<90%
기간: 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%
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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)
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2023년 3월 20일

기본 완료 (실제)

2024년 5월 31일

연구 완료 (실제)

2024년 5월 31일

연구 등록 날짜

최초 제출

2022년 9월 21일

QC 기준을 충족하는 최초 제출

2022년 12월 23일

처음 게시됨 (실제)

2022년 12월 28일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 11월 13일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 11월 12일

마지막으로 확인됨

2026년 11월 1일

추가 정보

이 연구와 관련된 용어

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

IPD 계획 설명

The research protocol will be announced later in the plan.

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

미국에서 제조되어 미국에서 수출되는 제품

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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