Application of High-flow Nasal Oxygen in Cesarean Section

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-01

Study Completion Date

2023-12-31

Brief Summary

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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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Detailed Description

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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.

Conditions

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Fetal Acidemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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air group

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

HFNO group

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.

Group Type EXPERIMENTAL

Optiflow high-flow nasal cannula system

Intervention Type DEVICE

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

Interventions

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Optiflow high-flow nasal cannula system

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

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes