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Application of High-flow Nasal Oxygen in Cesarean Section

Effect of Maternal Oxygen Supplementation by High-flow Nasal Oxygen Compared With Room Air on Fetal Acidemia

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05921955
Enrollment
120
Registered
2023-06-27
Start date
2023-07-01
Completion date
2023-12-31
Last updated
2024-01-26

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

Conditions

Fetal Acidemia

Keywords

high-flow nasal oxygen, cesarean section, oxygen, umbilical artery, acidemia

Brief summary

The study propose that the using the high-flow nasl oxygen to provide oxygen for maternal can improve the fetal acidemia and the neonatal outcomes during cesarean section with combined spinal-epidural anesthesia.

Detailed description

Maternal oxygen supplementation is widely used intrauterine resuscitation technique in clinical, which can improve fetal oxygenation and prevent fetal acidemia. The incidence of hypotension is high in cesarean section with combined spinal-epidural anesthesia. Hypotension contributes to insufficient perfusion of uterus and placenta, resulting in decreased fetal oxygen supply and neonatal acidemia. High flow nasal oxygen have a better improvement oxygenation of patients by providing high flow oxygen airflow with heating and humidification through nasal cannula.

Interventions

DEVICEOptiflow high-flow nasal cannula system

Using the Optiflow high-flow nasal cannula system to supply oxygen for maternal.

Sponsors

Beijing Tongren Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes

Inclusion criteria

* An elective cesarean section in Beijing Tongren Hospital * ≥37 weeks' gestation * American society of Aneshesiologists(ASA) I-III * Aged 18 to 45 years old * The fasting time is 6-8h, and the water restriction time is ≥2h * Anesthesia: combined spinal-epidural anesthesia * Agree to the study and sign the informed consent

Exclusion criteria

* Fetal or placental abnormalities are known * Maternal has complications * Maternal BMI ≥40 kg/m2 * History of difficult intubation or known difficult airway * Contraindications for HFNO such as nasal lesions or structural changes * Gastric reflux disease

Design outcomes

Primary

MeasureTime frameDescription
umbilical artery lactate, mmol/Lthe fetal deliverymmol/L

Secondary

MeasureTime frameDescription
umbilical artery pH valuethe fetal deliveryunitless
umbilical artery oxygen partial pressure(PO2)the fetal deliverymmHg
umbilical artery partial pressure of carbon dioxide(PCO2)the fetal deliverymmHg
umbilical artery base excess(BE), mmol/Lthe fetal deliverymmol/L
the incidence of pH<7.20 and pH<7.10the fetal deliverypercentage

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 7, 2026