Clinical trial NCT05666908: HFNO Improves Blood Oxygen Saturation During Asphyxia During Pulmonary Surgery With Double-lumen Endotracheal Intubation
Official title: High-flow Nasal Oxygenation Improves Blood Oxygen Saturation During Asphyxia During Pulmonary Surgery With Double-lumen Endotracheal Intubation: a Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Lung Neoplasms
Pneumothorax
Lead sponsor: Shenzhen Second People's Hospital
Sponsor class: OTHER
First posted: 2022-12-28
Enrollment: 112
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Minimum blood oxygen saturation (SpO2)
timeFrame: After the DLT intubation
Secondary outcomes:
measure: The incidence of lowest SpO2<90%
timeFrame: After the DLT intubation
measure: The incidence of lowest SpO2<95%
timeFrame: After the DLT intubation
measure: DLT intubation time
timeFrame: After the DLT intubation
measure: End-tidal carbon dioxide partial pressure after intubation
timeFrame: After the DLT intubation
measure: End-tidal oxygen concentration after intubation
timeFrame: After the DLT intubation
measure: The incidence of difficult airway
timeFrame: After the DLT intubation
measure: The incidence of bronchial dislocation
timeFrame: After the DLT intubation
measure: Incidence of related complications during intubation
timeFrame: After the DLT intubation
measure: Operator satisfaction with intubation
timeFrame: After the DLT intubation
measure: The incidence of low blood oxygen saturation (SpO2<90%) in the post-anaesthesia care unit (PACU)
timeFrame: Up to 1 week
measure: The incidence of postoperative airway-related complications
timeFrame: 1st, 2nd and 3rd day after surgery
measure: The incidence of nausea and vomiting
timeFrame: 1st, 2nd and 3rd day after surgery
measure: Patient satisfaction with anesthesia
timeFrame: The first day after surgery
measure: Postoperative hospital stay
timeFrame: Through study completion, an average of 4 weeks
measure: The incidence of postoperative complication
timeFrame: Through study completion, an average of 4 weeks
Other outcomes:
Locations:
Study officials:
References:
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