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

NCT05666908 | Unknown

• 1 other identifier: 20223357001
• Study Type: interventional
• Target: 112
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Lung Neoplasms; Pneumothorax

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (15)

• The incidence of lowest SpO2<90%

  After the DLT intubation

• The incidence of lowest SpO2<95%

  After the DLT intubation

• DLT intubation time

  After the DLT intubation

• End-tidal carbon dioxide partial pressure after intubation

  After the DLT intubation

• End-tidal oxygen concentration after intubation

  After the DLT intubation

Study Arms (2)

HFNO group

EXPERIMENTAL

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

Device: HFNO

Control group

NO INTERVENTION

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

Interventions

HFNO DEVICE

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.

Also known as: high flow nasal oxygen therapy

HFNO group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age 18-60;
• Patients planning to undergo video-assisted thoracoscopic (VATS) lung surgery requiring DLT intubation;
• Patients who agreed to participate in this study.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shenzhen Second People's Hospital: lead

Related Publications (9)

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  PMID: 34105065 BACKGROUND

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  PMID: 32925331 BACKGROUND

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  PMID: 26556848 BACKGROUND

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  PMID: 31163107 BACKGROUND

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  PMID: 29397127 BACKGROUND

• 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.

  PMID: 25388828 BACKGROUND

• 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.

  PMID: 22050948 BACKGROUND

• 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.

  PMID: 31533792 BACKGROUND

• He R, Fang Y, Jiang Y, Yao D, Li Z, Zheng W, Liu Z, Luo N. High-flow nasal oxygenation versus face mask oxygenation for preoxygenation in patients undergoing double-lumen endobronchial intubation: protocol of a randomised controlled trial. BMJ Open. 2024 Mar 14;14(3):e080422. doi: 10.1136/bmjopen-2023-080422.

  PMID: 38485472 DERIVED

MeSH Terms

Conditions

Lung Neoplasms; Pneumothorax

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Pleural Diseases

Central Study Contacts

Nanbo Luo, MD.

CONTACT

+86-15112389303; 316916645@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2022
• First Posted: December 28, 2022
• Study Start: January 1, 2023
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: December 28, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share