HFNO Improves Blood Oxygen Saturation During Asphyxia During Pulmonary Surgery With Double-lumen Endotracheal Intubation

Study Overview
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Brief Summary
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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.

Official Title
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High-flow Nasal Oxygenation Improves Blood Oxygen Saturation During Asphyxia During Pulmonary Surgery With Double-lumen Endotracheal Intubation: a Randomized Controlled Study

Conditions
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Lung Neoplasms, Pneumothorax

Intervention / Treatment
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* Device: HFNO


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HFNO group<br>Direct guidance and positioning of DLT intubation with FOB visualization, using HFNO during intubation asphyxia. | Device: HFNO<br>* 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.<br>* Other names: high flow nasal oxygen therapy;|
| No Intervention: Control group<br>The DLT cannula was directly guided and positioned under FOB visualization, and no oxygen therapy equipment was used during intubation. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Minimum blood oxygen saturation (SpO2) | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence of lowest SpO2<90% | 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% | 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 | 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 | 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 | 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 | Difficult airway was defined as failure of videolaryngoscope intubation, switch to fiberoptic bronchoscope-guided intubation. | After the DLT intubation | 
| The incidence of bronchial dislocation | Left or right bronchial tube strayed into right or left bronchus. | After the DLT intubation | 
| Incidence of related complications during 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 | 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) | 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 | Postoperative airway-related complications include: sore throat, hoarseness, and nasopharyngeal dryness. | 1st, 2nd and 3rd day after surgery | 
| The incidence of nausea and vomiting | Interview patients' subjective feelings, including nausea and vomiting. | 1st, 2nd and 3rd day after surgery | 
| Patient satisfaction with anesthesia | 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 | 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 | Postoperative complications included postoperative atelectasis, pneumothorax, pulmonary infection, pleural effusion, bronchopleural fistula and postoperative bleeding. | Through study completion, an average of 4 weeks |