NCT07843810Not yet recruiting
Effect of Different-Flow High-Flow Nasal Cannula Versus Traditional Face Mask Oxygenation on Safe Apnea Time in Obese Patients
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
Source: ClinicalTrials.gov · Last updated 28 Sept 2026
Brief summary (registry, in English)
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. 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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 147 (estimated)
- First submitted
- 6 Sept 2026
- Start date
- 1 Oct 2026
- Primary completion date
- 31 May 2027
- Lead sponsor
- The First People's Hospital of Lianyungang
- Diseases
- Obesity
- NCT number
- NCT07843810
What you commit to
- Study type: Interventional
- Planned participants: 147
- From 1 Oct 2026 to the primary completion date, 31 May 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Current smoker or former smoker who quit less than 1 year prior to enrollment
- Participation in another interventional clinical trial within 30 days prior to enrollment
Other illness
- 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
- Severe nasal obstructive disease that affects nasal ventilation or intubation
Other
- Pregnancy
- Baseline peripheral oxygen saturation (SpO₂) \< 95%
- Known or anticipated difficult airway
Who the study is looking for
- 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
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The First People's Hospital of Lianyungang Coordinator of this site? Confirm its status | Lianyungang | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.