Application of High-flow Nasal Oxygen in Cesarean Section

Not Applicable

Completed

• Conditions: Fetal Acidemia

• Registration Number: NCT05921955
• Lead Sponsor: Beijing Tongren Hospital

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.

Study Timeline

• Status Verified: 2023-04
• Study First Submitted: 2023-06-15
• Study First Submitted QC: 2023-06-25
• Study First Posted: 2023-06-27
• Study Start: 2023-07-01
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31
• Last Update Submitted: 2024-01-25
• Last Update Posted: 2024-01-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
umbilical artery lactate, mmol/L	the fetal delivery	mmol/L

Secondary Outcome Measures

Name	Time	Method
umbilical artery pH value	the fetal delivery	unitless
umbilical artery partial pressure of carbon dioxide(PCO2)	the fetal delivery	mmHg
umbilical artery base excess(BE), mmol/L	the fetal delivery	mmol/L
the incidence of pH<7.20 and pH<7.10	the fetal delivery	percentage
umbilical artery oxygen partial pressure(PO2)	the fetal delivery	mmHg

Trial Locations

Locations (1)

Beijing tongren Hospital, Capital Medical University; 🇨🇳 Beijing, Beijing, China