Application of High-flow Nasal Oxygen in Cesarean Section

Capital Medical University

Status: Completed

Conditions: Fetal Acidemia

Treatments: Device: Optiflow high-flow nasal cannula system

Study type: Interventional

Funder types: Other

Identifiers

NCT05921955

TREC2023-KY021

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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120 participants in 2 patient groups

air group

No Intervention group

Description:

the patients of the air group receive the 2L/min with air pattern by the Optiflow high-flow nasal cannula system from anesthesia to fetal delivery.

HFNO group

Experimental group

Description:

For HFNO group, a flow rate of 40L/min, with 100% oxygen concentration and a temperature of 37℃ by the Optiflow high-flow nasal cannula system from anesthesia to fetal delivery.

Treatment:

Device: Optiflow high-flow nasal cannula system