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Completed

NCT Number: NCT05921955

Application of High-flow Nasal Oxygen in Cesarean Section

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.

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Key information

Conditions

Fetal Acidemia

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Beijing tongren Hospital, Capital Medical University

Beijing, Beijing Municipality, 100000, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Optiflow high-flow nasal cannula system

Device

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

Primary outcomes

  1. umbilical artery lactate, mmol/L

    Time frame: the fetal delivery

    mmol/L

Secondary outcomes

  1. umbilical artery pH value

    Time frame: the fetal delivery

    unitless

  2. umbilical artery oxygen partial pressure(PO2)

    Time frame: the fetal delivery

    mmHg

  3. umbilical artery partial pressure of carbon dioxide(PCO2)

    Time frame: the fetal delivery

    mmHg

  4. umbilical artery base excess(BE), mmol/L

    Time frame: the fetal delivery

    mmol/L

  5. the incidence of pH<7.20 and pH<7.10

    Time frame: the fetal delivery

    percentage

Sponsors and collaborators

Lead sponsor

Beijing Tongren Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jun 27, 2023
Registry last updated
Jan 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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