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Comparison of Oxygenation Efficacy and Safety Between Facemask Combined with Nasopharyngeal Airway and High-Flow Nasal Oxygen Therapy During General Anesthesia Induction in Obese Parturients Undergoing Cesarean Delivery: A Dual-Center, Randomized Controlled Study

Comparison of Oxygenation Efficacy and Safety Between Facemask Combined with Nasopharyngeal Airway and High-Flow Nasal Oxygen Therapy During General Anesthesia Induction in Obese Parturients Undergoing Cesarean Delivery

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500105961
Enrollment
Unknown
Registered
2025-07-15
Start date
2025-07-31
Completion date
Unknown
Last updated
2025-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Preoxygenation before general anesthesia induction in obese parturients for cesarean delivery

Interventions

Face Mask with nasopharyngeal airway group:Standard preoxygenation was performed with 100% oxygen at 10 L/min via a tightly sealed facemask for 3 minutes before anesthesia induction. Following loss of
High-flow nasal oxygen group:Pre-induction high-flow nasal oxygen (HFNO) was administered at 50 L/min with FiO2 1.0 and 37°C for 3 minutes prior to anesthesia induction. The HFNO device was maintained

Sponsors

Shanghai First Maternity and Infant Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. ASA physical status ?-III; 2. Term pregnancy (gestational age >=37 weeks); 3. Age >=18 years; 4. Nulliparous women with singleton pregnancy; 5. BMI >=30 kg/m²; 6. Scheduled for elective cesarean delivery under general anesthesia.

Exclusion criteria

Exclusion criteria: 1. Parturients with difficult airway or gastroesophageal reflux disease (GERD); 2. Those with preexisting respiratory comorbidities that may affect ventilation/oxygenation; 3. Severe nasal pathology or obstruction (mouth-breathing only); 4. Systemic/chronic conditions (e.g., eclampsia/preeclampsia); 5. Fetal distress; 6. Inability to comply with study procedures; 7. Participation in other clinical trials within 2 weeks prior to enrollment.

Design outcomes

Primary

MeasureTime frame
FetO2 of the parturients immediately after the intubation;

Secondary

MeasureTime frame
lowest SpO2 during intubation;the times of difficult intubation;End-tidal carbon dioxide partial pressure immediately after intubation;Apneic oxygenation time;Anesthesia to skin incision time;incision-to-delivery interval (IDI);neonate Apgar score;neonate weight;

Countries

China

Contacts

Public ContactZhou Shuangqiong

Shanghai First Maternity and Infant Hospital

zsq628628@163.com+86 139 1617 4158

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026