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

Not Applicable

Not yet recruiting

• Conditions: Pneumothorax; Lung Neoplasms
• Interventions: Device: HFNO

• Registration Number: NCT05666908
• Lead Sponsor: Shenzhen Second People's Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-09
• Study First Submitted: 2022-09-21
• Study First Submitted QC: 2022-12-23
• Last Update Submitted: 2022-12-23
• Study First Posted: 2022-12-28
• Last Update Posted: 2022-12-28
• Study Start: 2023-01
• Primary Completion: 2024-12
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 112

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Minimum blood oxygen saturation (SpO2)	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.

Secondary Outcome Measures

Name	Time	Method
Operator satisfaction with intubation	After the DLT intubation	Operator satisfaction rating for intubation (range 0-10, with 0 being very dissatisfied and 10 being very satisfied).
The incidence of low blood oxygen saturation (SpO2<90%) in the post-anaesthesia care unit (PACU)	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.
The incidence of lowest SpO2<90%	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.
Incidence of related complications during intubation	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.
The incidence of postoperative airway-related complications	1st, 2nd and 3rd day after surgery	Postoperative airway-related complications include: sore throat, hoarseness, and nasopharyngeal dryness.
The incidence of lowest SpO2<95%	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.
DLT intubation time	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.
End-tidal oxygen concentration after intubation	After the DLT intubation	When the tracheal intubation is completed, the monitor displays the end-expiratory oxygen concentration of the first mechanical ventilation.
End-tidal carbon dioxide partial pressure after intubation	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.
The incidence of difficult airway	After the DLT intubation	Difficult airway was defined as failure of videolaryngoscope intubation, switch to fiberoptic bronchoscope-guided intubation.
The incidence of bronchial dislocation	After the DLT intubation	Left or right bronchial tube strayed into right or left bronchus.
The incidence of nausea and vomiting	1st, 2nd and 3rd day after surgery	Interview patients' subjective feelings, including nausea and vomiting.
Patient satisfaction with anesthesia	The first day after surgery	Patient satisfaction with anesthesia(range 0-10, with 0 being very dissatisfied and 10 being very satisfied).
Postoperative hospital stay	Through study completion, an average of 4 weeks	The medical record system queries the number of days in hospital after surgery.
The incidence of postoperative complication	Through study completion, an average of 4 weeks	Postoperative complications included postoperative atelectasis, pneumothorax, pulmonary infection, pleural effusion, bronchopleural fistula and postoperative bleeding.