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

Lung Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05666908
• Other study ID #: 20223357001
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 2023
• Est. completion date: December 2024

Study information

• Verified date: September 2022
• Source: Shenzhen Second People's Hospital
• Contact: Nanbo Luo, MD.
• Phone: +86-15112389303
• Email: 316916645[@]qq.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 112
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Asphyxia
• Lung Neoplasms
• Pneumothorax

Intervention

Device:
• HFNO
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Shenzhen Second People's Hospital

References & Publications (8)

Fong KM, Au SY, Ng GWY. Preoxygenation before intubation in adult patients with acute hypoxemic respiratory failure: a network meta-analysis of randomized trials. Crit Care. 2019 Sep 18;23(1):319. doi: 10.1186/s13054-019-2596-1. — View Citation

Frerk C, Mitchell VS, McNarry AF, Mendonca C, Bhagrath R, Patel A, O'Sullivan EP, Woodall NM, Ahmad I; Difficult Airway Society intubation guidelines working group. Difficult Airway Society 2015 guidelines for management of unanticipated difficult intubation in adults. Br J Anaesth. 2015 Dec;115(6):827-48. doi: 10.1093/bja/aev371. Epub 2015 Nov 10. — View Citation

Kim HJ, Asai T. High-flow nasal oxygenation for anesthetic management. Korean J Anesthesiol. 2019 Dec;72(6):527-547. doi: 10.4097/kja.19174. Epub 2019 Jun 5. — View Citation

Law JA, Duggan LV, Asselin M, Baker P, Crosby E, Downey A, Hung OR, Kovacs G, Lemay F, Noppens R, Parotto M, Preston R, Sowers N, Sparrow K, Turkstra TP, Wong DT, Jones PM; Canadian Airway Focus Group. Canadian Airway Focus Group updated consensus-based recommendations for management of the difficult airway: part 2. Planning and implementing safe management of the patient with an anticipated difficult airway. Can J Anaesth. 2021 Sep;68(9):1405-1436. doi: 10.1007/s12630-021-02008-z. Epub 2021 Jun 8. — View Citation

Patel A, Nouraei SA. Transnasal Humidified Rapid-Insufflation Ventilatory Exchange (THRIVE): a physiological method of increasing apnoea time in patients with difficult airways. Anaesthesia. 2015 Mar;70(3):323-9. doi: 10.1111/anae.12923. Epub 2014 Nov 10. — View Citation

Renda T, Corrado A, Iskandar G, Pelaia G, Abdalla K, Navalesi P. High-flow nasal oxygen therapy in intensive care and anaesthesia. Br J Anaesth. 2018 Jan;120(1):18-27. doi: 10.1016/j.bja.2017.11.010. Epub 2017 Nov 21. — View Citation

Spence EA, Rajaleelan W, Wong J, Chung F, Wong DT. The Effectiveness of High-Flow Nasal Oxygen During the Intraoperative Period: A Systematic Review and Meta-analysis. Anesth Analg. 2020 Oct;131(4):1102-1110. doi: 10.1213/ANE.0000000000005073. — View Citation

Weingart SD, Levitan RM. Preoxygenation and prevention of desaturation during emergency airway management. Ann Emerg Med. 2012 Mar;59(3):165-75.e1. doi: 10.1016/j.annemergmed.2011.10.002. Epub 2011 Nov 3. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	The incidence of difficult airway	Difficult airway was defined as failure of videolaryngoscope intubation, switch to fiberoptic bronchoscope-guided intubation.	After the DLT intubation
Secondary	The incidence of bronchial dislocation	Left or right bronchial tube strayed into right or left bronchus.	After the DLT intubation
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	The incidence of nausea and vomiting	Interview patients' subjective feelings, including nausea and vomiting.	1st, 2nd and 3rd day after surgery
Secondary	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
Secondary	Postoperative hospital stay	The medical record system queries the number of days in hospital after surgery.	Through study completion, an average of 4 weeks
Secondary	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