ClinicalTrials.gg
CompletedNCT05666908Updated Nov 13, 2026

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

An interventional study of HFNO in Lung Neoplasms and Pneumothorax, sponsored by Shenzhen Second People's Hospital. Completed at 1 site in China. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-11-13.

Sponsored by Shenzhen Second People's Hospital · Not applicable, Interventional, and Treatment

Updated Nov 13, 2026Now CompletedFirst site in China+5 moreGo to Updates ↓

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Phase
Not applicable
Study type
Interventional
Enrollment
112
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 844 studies in Lung Neoplasms with a site in China — 371 open to participants now, 418 under way, 34 of them phase 3. Lung Neoplasms · China.

Enrollment
243rd of 585
112 · median 90
Started
2023
with 72 others
No phase
212 of 844
91 open now
Registered
419th of 844
by date

Among the 844 studies in Lung Neoplasms with a site in China, this one is the 243rd largest by enrollment of the 585 interventional ones that give a count, is one of 73 that started in 2023, is one of 212 with no phase, and was the 419th registered.

Lung Neoplasms

5,423 studies on the registry are indexed under Lung Neoplasms; 1,345 are open to participants now.

Browse Lung Neoplasms studies →

Open to participants now

371 of the 844 studies in Lung Neoplasms with a site in China are open now. Recruiting first, the newest first:

366 more — sign in →

All 371 open studies →

A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →

Who these studies take

Of the 995 Lung Neoplasms studies recruiting now, 682 (69%) set no upper age limit and 142 (14%) stop at 75 or younger; 45 take children under 18; 142 take healthy volunteers.

This study: 18 Years to 60 Years · all sexes · no healthy volunteers.

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02

Study 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.

03

Conditions studied

  • Lung Neoplasms
  • Pneumothorax
04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • (ASA) classification > IV;
  • Patients with severe nasal obstruction; expected difficult intubation or difficulty with mask ventilation;
  • Morbid obesity [ (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.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ASA physical status

The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Outcomes assessor)
Enrollment
112 participants (actual)

Study arms

  • Experimental
    HFNO group

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

    Device: HFNO

  • No intervention
    Control group

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

Interventions

  • DeviceHFNO

    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

06

What researchers measure

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.

    Time frame: After the DLT intubation

Secondary outcomes

  1. 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.

    Time frame: After the DLT intubation

  2. 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.

    Time frame: After the DLT intubation

  3. 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.

    Time frame: After the DLT intubation

  4. 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.

    Time frame: After the DLT intubation

  5. 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.

    Time frame: After the DLT intubation

  6. The incidence of difficult airway

    Difficult airway was defined as failure of videolaryngoscope intubation, switch to fiberoptic bronchoscope-guided intubation.

    Time frame: After the DLT intubation

  7. The incidence of bronchial dislocation

    Left or right bronchial tube strayed into right or left bronchus.

    Time frame: After the DLT intubation

  8. 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.

    Time frame: After the DLT intubation

  9. Operator satisfaction with intubation

    Operator satisfaction rating for intubation (range 0-10, with 0 being very dissatisfied and 10 being very satisfied).

    Time frame: After the DLT intubation

  10. 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.

    Time frame: Up to 1 week

  11. The incidence of postoperative airway-related complications

    Postoperative airway-related complications include: sore throat, hoarseness, and nasopharyngeal dryness.

    Time frame: 1st, 2nd and 3rd day after surgery

  12. The incidence of nausea and vomiting

    Interview patients' subjective feelings, including nausea and vomiting.

    Time frame: 1st, 2nd and 3rd day after surgery

  13. Patient satisfaction with anesthesia

    Patient satisfaction with anesthesia(range 0-10, with 0 being very dissatisfied and 10 being very satisfied).

    Time frame: The first day after surgery

  14. Postoperative hospital stay

    The medical record system queries the number of days in hospital after surgery.

    Time frame: Through study completion, an average of 4 weeks

  15. The incidence of postoperative complication

    Postoperative complications included postoperative atelectasis, pneumothorax, pulmonary infection, pleural effusion, bronchopleural fistula and postoperative bleeding.

    Time frame: Through study completion, an average of 4 weeks

07

Study locations

1 site
  • Shenzhen Second People's Hospital
    Shenzhen, Guangdong 518000, China
08

References and documents

Publications

  • 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. PubMed 34105065 ↗
  • 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. PubMed 32925331 ↗
  • 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. PubMed 26556848 ↗
  • 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. PubMed 31163107 ↗
  • 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. PubMed 29397127 ↗
  • 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. PubMed 25388828 ↗
  • 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. PubMed 22050948 ↗
  • 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. PubMed 31533792 ↗
  • 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. PubMed 38485472 ↗

Individual participant data

Plan to share: No — The research protocol will be announced later in the plan.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it movedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Mar 2023 to primary completion in May 2024, 14 months.

Of 864 non-industry interventional studies with no phase under Lung Neoplasms, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 68. This study's 14 months is below that.

Counting every sponsor, half of 915 studies reached it within 34 months; a quarter within 15 and three quarters within 67.

Since we started tracking on Sep 25, 2026, the dates moved once, on Nov 13, 2026: start Jan 2023 → Mar 2023, primary completion Dec 2024 → May 2024 and completion Dec 2024 → May 2024.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
Sep 21, 2022
First posted
Dec 28, 2022
StartActual
Mar 20, 2023was Jan 2023
Primary completionActual
May 31, 2024was Dec 2024
CompletionActual
May 31, 2024was Dec 2024
Last update
Nov 13, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Status
Status unknown→Completed
changed Nov 13, 2026
Sites
1 site added — first site in China
Show site
  • Shenzhen Second People's Hospital · Shenzhen, China
Nov 13, 2026
Start date
Jan 2023→Mar 20, 2023 (actual)
Nov 13, 2026
Primary completion
Dec 2024→May 31, 2024 (actual)
Nov 13, 2026
Study completion
Dec 2024→May 31, 2024 (actual)
Nov 13, 2026
Publications
1 publication citing this study linked from PubMed, e.g. PubMed 38485472 ↗
Nov 13, 2026
Show all 1 update
  1. Nov 13, 2026
    Status unknown→Completed
    Publications 1 publication citing this study linked from PubMed, e.g. PubMed 38485472 ↗
    1 site added — first site in China
    Show site
    • Shenzhen Second People's Hospital · Shenzhen, China
    Start date Jan 2023→Mar 20, 2023 (now actual)
    Primary completion Dec 2024→May 31, 2024 (now actual)
    Study completion Dec 2024→May 31, 2024 (now actual)
    + 2 other changes: verification date and contact details

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT05666908
Lead sponsor
Shenzhen Second People's Hospital
Responsible party
Sponsor
First posted
Dec 28, 2022
Start date
Mar 20, 2023
Primary completion
May 31, 2024
Completion
May 31, 2024
Last update
Nov 13, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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