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ObesityNCT07843810

Effect of Different-Flow High-Flow Nasal Cannula Versus Traditional Face Mask Oxygenation on Safe Apnea Time in Obese Patients

A study testing Face Mask and High-Flow Nasal Cannula in people with Obesity, run by The First People's Hospital of Lianyungang at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

Obesity is a growing global health problem, and patients with obesity are at higher risk of hypoxemia during induction of general anesthesia. This is because excess body weight reduces the lungs' oxygen storage capacity, causing blood oxygen saturation to decline faster than in normal-weight individuals once breathing… Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Obesity
What is being tested?
Face Mask and High-Flow Nasal Cannula
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
147 participants
Where
1 siteChina
Study dates
1 Oct 2026to 1 Jul 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age 18 to 65 years
  • American Society of Anesthesiologists (ASA) physical status I ~ III
  • Scheduled for elective surgery under general anesthesia with endotracheal intubation
  • Body mass index (BMI) ≥ 28 kg/m²
  • Willing and able to provide written informed consent

Who cannot join

  • Cardiac disease including ischemic heart disease, heart failure (New York Heart Association class ≥ 2), current arrhythmia, or pulmonary hypertension
  • Severe asthma or moderate to severe chronic obstructive pulmonary disease
  • Pregnancy
  • Current smoker or former smoker who quit less than 1 year prior to enrollment
  • Baseline peripheral oxygen saturation (SpO₂) < 95%
  • Severe nasal obstructive disease that affects nasal ventilation or intubation
  • Known or anticipated difficult airway
  • Participation in another interventional clinical trial within 30 days prior to enrollment

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Xiaobao Zhang contact

18961322507

hotdog100@163.com

China1 site
  • The First People's Hospital of Lianyungang

    Lianyungang, Jiangsu, 222061

    Caifeng Wang, 15664709156, 15664709156@163.com

Other trials in China

About this study

Official title: Effect of Different-Flow High-Flow Nasal Cannula Versus Traditional Face Mask Oxygenation on Safe Apnea Time in Obese Patients: A Prospective Randomized Controlled Trial

Obesity is a growing global health problem, and patients with obesity are at higher risk of hypoxemia during induction of general anesthesia. This is because excess body weight reduces the lungs' oxygen storage capacity, causing blood oxygen saturation to decline faster than in normal-weight individuals once breathing stops. Currently, the most common preventive method is preoxygenation with a face mask delivering 100% oxygen for several minutes before anesthesia induction. However, face masks often fail to seal properly in obese patients, potentially compromising preoxygenation effectiveness.

High-flow nasal oxygen therapy is a newer technique that delivers heated and humidified oxygen at high flow rates through nasal cannulae. It not only provides effective preoxygenation but may also continue to supply oxygen during apnea (apneic oxygenation), thereby prolonging the safe apnea time. Nevertheless, it remains unclear which flow rate is most effective and whether high-flow nasal oxygen is truly superior to conventional face masks.

Read more

This prospective randomized controlled trial will enroll 147 obese patients (BMI ≥ 28kg/m²) scheduled for elective surgery at Lianyungang First People's Hospital. Participants will be randomly assigned to one of three groups: (1) traditional face mask preoxygenation at 15 L/min, (2) high-flow nasal oxygen at 45 L/min, or (3) high-flow nasal oxygen at 70 L/min. All patients will receive 100% oxygen for 3 minutes. The primary outcome is safe apnea time - the duration from cessation of breathing until SpO₂ drops to 93%. Secondary outcomes include arterial blood gas values, patient comfort during preoxygenation, tolerance rate, and hemodynamic stability.

The study hypothesis is that high-flow nasal oxygen at 70 L/min will provide a longer safe apnea time than both traditional face mask preoxygenation and high-flow nasal oxygen at 45 L/min in obese patients. The results will provide high-quality evidence for optimizing perioperative preoxygenation strategies in this population.

Read the detailed description

Obesity is a growing global health issue, and obese patients have higher rates of difficult airway and faster desaturation during apnea due to reduced functional residual capacity, decreased lung compliance, and increased oxygen consumption. Traditional face mask preoxygenation (FiO₂ = 1.0) is widely used but often compromised by poor mask seal and patient intolerance. High-flow nasal cannula (HFNC) delivers heated, humidified high-flow oxygen, maintains airway pressure, and enables apneic oxygenation, potentially prolonging safe apnea time. However, evidence remains limited due to small sample sizes, inconsistent desaturation thresholds, and non-standardized flow protocols. This study aims to compare three preoxygenation strategies in obese patients.

This is a prospective, randomized, open-label, three-arm parallel trial at a single center. Enrollment runs from July 2026 to May 2027. We plan to include 147 adults (18-65 years, ASA I-III, BMI ≥ 28) undergoing elective surgery with general anesthesia and tracheal intubation. Key exclusions are severe cardiac or pulmonary disease, pregnancy, current smoking, baseline SpO₂ < 95%, severe nasal obstruction, known difficult airway, or recent trial participation. All patients fast routinely and receive standard monitoring plus radial artery cannulation. Preoxygenation lasts 3 minutes with mouth closed: FM group - face mask 15 L/min; HF45 - nasal high-flow 45 L/min; HF70 - nasal high-flow 70 L/min. Anesthesia is induced with propofol, sufentanil, and rocuronium (dosed by predicted body weight). After loss of consciousness, an oropharyngeal airway and jaw thrust maintain patency. On confirmed apnea, oxygen is stopped. Intubation is performed with video laryngoscope within 45-60 seconds. After tube placement, patients remain apneic with tube open to air until SpO₂ reaches 93%, when mechanical ventilation starts.

The primary outcome is safe apnea time (seconds from apnea onset to SpO₂ = 93%). Secondary outcomes are arterial blood gases at multiple time points, VAS comfort score (0-10), tolerance rate, and hemodynamic variables (blood pressure, heart rate) at pre-induction, post-induction, and intubation. Sample size calculation: based on prior meta-analysis (mean difference ~60 sec, SD ~90 sec, effect size 0.67), with α = 0.05 (two-sided), power 0.80, and Bonferroni correction for two primary comparisons (α' = 0.025), ~44 per group are needed. With 10% dropout, total 147 (49 per group). Statistical analysis uses independent t-tests or Mann-Whitney U with Bonferroni correction for continuous variables, and Fisher's exact or chi-square for categorical variables, with multiple comparison adjustments as appropriate. Data are recorded, double-entered, and verified. Equipment is calibrated regularly. The ethics committee approved the protocol. Written informed consent is obtained from all participants, who may withdraw anytime. Results will be published irrespective of outcome.

Conditions
Obesity
Being tested
Face Mask, High-Flow Nasal Cannula
Keywords
Obesity, Preoxygenation, High-Flow Nasal Oxygen, Airway Management
Medical subject headings
Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Face MaskDevice

    Face mask preoxygenation delivered via a tight-fitting mask (appropriate size selected based on facial dimensions) with oxygen flow at 15 L/min, FiO₂ = 1.0 (100% oxygen), for 3 minutes during tidal breathing.

  • High-Flow Nasal CannulaDevice

    High-flow nasal oxygen delivered via a dedicated nasal cannula (size selected based on nostril size), with FiO₂ = 1.0 (100% oxygen), gas heated and humidified (37°C, 100% relative humidity), for 3 minutes with mouth closed and nasal breathing. Flow rates are 45 L/min for the HF45 group and 70 L/min for the HF70 group.

Study groups in NCT07843810
Study groupRoleWhat they receive
Face Mask 15 L/minActive comparatorParticipants receive preoxygenation via a tight-fitting face mask (appropriate size selected based on facial dimensions) with oxygen flow at 15 L/min, FiO₂ = 1.0 (100% oxygen), for 3 minutes during tidal breathing. Preoxygenation is followed by standardized anesthesia induction and endotracheal intubation.
Receives: Device: Face Mask
High-Flow Nasal Oxygen 45 L/minExperimentalParticipants receive preoxygenation via a high-flow nasal cannula device (nasal cannula size selected based on nostril size) with oxygen flow at 45 L/min, FiO₂ = 1.0 (100% oxygen), gas heated and humidified (37°C, 100% relative humidity), for 3 minutes with mouth closed and nasal breathing. Preoxygenation is followed by standardized anesthesia induction and endotracheal intubation.
Receives: Device: High-Flow Nasal Cannula
High-Flow Nasal Oxygen 70 L/minExperimentalParticipants receive preoxygenation via a high-flow nasal cannula device (nasal cannula size selected based on nostril size) with oxygen flow at 70 L/min, FiO₂ = 1.0 (100% oxygen), gas heated and humidified (37°C, 100% relative humidity), for 3 minutes with mouth closed and nasal breathing. Preoxygenation is followed by standardized anesthesia induction and endotracheal intubation.
Receives: Device: High-Flow Nasal Cannula

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safe Apnea Time

    Safe apnea time is defined as the duration from the onset of apnea (cessation of ventilation after complete neuromuscular blockade following rocuronium administration) to the first decline of peripheral oxygen saturation (SpO₂) to 93%, measured in seconds. Apnea is confirmed by visual assessment by a study team member. Oxygen delivery is discontinued upon confirmation of apnea. The patient remains apneic with the endotracheal tube open to atmosphere until the SpO₂ threshold is reached, at which point mechanical ventilation is initiated and the apnea period is terminated.

    Measured: From apnea onset to first SpO2 decrease to 93%, assessed up to 10 minutes (600 seconds) after apnea onset; censored if ventilation resumes before SpO2 reaches 93%.

Secondary outcomes (7)
  1. Arterial Blood Gas Measurements During Preoxygenation and Apnea

    Arterial blood gases are measured at the following time points: (1) at baseline (before preoxygenation), (2) during preoxygenation (at 1 minute and 2 minutes and 3 minutes), (3) immediately at the onset of apnea, (4) during apnea (at 1-minute intervals), and (5) immediately at termination of apnea when SpO₂ reaches 93%. Parameters measured include PaO₂, PaCO₂, pH, and other standard blood gas variables.

    Measured: From baseline (before preoxygenation) to apnea termination (first SpO2 decrease to 93% or ventilation resumption), assessed up to approximately 13 min (780 sec; preoxygenation up to 3 min + apnea up to 10 min).

  2. Preoxygenation Comfort Visual Analog Scale Score

    Patient comfort during the 3-minute preoxygenation period is assessed using a visual analog scale (VAS) ranging from 0 to 10, where 0 represents no discomfort and 10 represents extreme discomfort. Patients are asked to indicate their score using a finger marker at approximately 2.5 minutes after the start of preoxygenation.

    Measured: Single assessment at 2.5 minutes after start of preoxygenation, during the 3-minute preoxygenation period.

  3. Preoxygenation Tolerance Rate

    Preoxygenation tolerance rate is defined as the proportion of patients who complete the full 3-minute preoxygenation period without refusal or requiring adjustment of the intervention. Patients who discontinue or request modification of the preoxygenation method during the 3-minute period are recorded as intolerance events.

    Measured: From start of preoxygenation to end of preoxygenation, assessed up to 3 minutes.

  4. Systolic blood pressure (SBP)

    Systolic blood pressure measured by invasive radial artery monitoring at three time points: (1) baseline before anesthesia induction; (2) immediately after induction (after loss of consciousness following propofol and sufentanil); and (3) immediately after endotracheal intubation.

    Measured: Baseline (before induction), immediately after induction, and immediately after intubation; assessed up to immediately after intubation.

  5. Diastolic blood pressure (DBP)

    Diastolic blood pressure measured by invasive radial artery monitoring at three time points: (1) baseline before anesthesia induction; (2) immediately after induction (after loss of consciousness following propofol and sufentanil); and (3) immediately after endotracheal intubation.

    Measured: Baseline (before induction), immediately after induction, and immediately after intubation; assessed up to immediately after intubation.

  6. Mean arterial pressure (MAP)

    Mean arterial pressure measured by invasive radial artery monitoring at three time points: (1) baseline before anesthesia induction; (2) immediately after induction (after loss of consciousness following propofol and sufentanil); and (3) immediately after endotracheal intubation.

    Measured: Baseline (before induction), immediately after induction, and immediately after intubation; assessed up to immediately after intubation.

  7. Heart rate (HR)

    Heart rate measured by invasive radial artery monitoring at three time points: (1) baseline before anesthesia induction; (2) immediately after induction (after loss of consciousness following propofol and sufentanil); and (3) immediately after endotracheal intubation.

    Measured: Baseline (before induction), immediately after induction, and immediately after intubation; assessed up to immediately after intubation.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Sep 2026
  2. Study start1 Oct 2026 (estimated)
  3. Primary completion31 May 2027 (estimated)
  4. Study completion1 Jul 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
147 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07843810
Sponsor's protocol ID
KY-20260701002-01
Status last verified
Sep 2026
First submitted
6 Sep 2026
Last updated
28 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Face Mask and High-Flow Nasal Cannula in people with Obesity, run by The First People's Hospital of Lianyungang at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 28 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Xiaobao Zhang (18961322507, hotdog100@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safe Apnea Time (time frame: From apnea onset to first SpO2 decrease to 93%, assessed up to 10 minutes (600 seconds) after apnea onset; censored if ventilation resumes before SpO2 reaches 93%.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2026.

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