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

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.

Study Overview

• Status: Completed
• Conditions: Fetal Acidemia
• Intervention / Treatment: Device: Optiflow high-flow nasal cannula system

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 Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100000
      • Beijing Tongren Hospital, Capital Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: 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.
Experimental: 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.	Device: Optiflow high-flow nasal cannula system; Using the Optiflow high-flow nasal cannula system to supply oxygen for maternal.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
umbilical artery lactate, mmol/L	mmol/L	the fetal delivery

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Beijing Tongren Hospital
• Investigators: Study Director: Guyan Wang, Beijing Tongren Hospital

Publications and helpful links

General Publications

• Qian G, Xu X, Chen L, Xia S, Wang A, Chuai Y, Jiang W. The effect of maternal low flow oxygen administration during the second stage of labour on umbilical cord artery pH: a randomised controlled trial. BJOG. 2017 Mar;124(4):678-685. doi: 10.1111/1471-0528.14418.
• Raghuraman N, Wan L, Temming LA, Woolfolk C, Macones GA, Tuuli MG, Cahill AG. Effect of Oxygen vs Room Air on Intrauterine Fetal Resuscitation: A Randomized Noninferiority Clinical Trial. JAMA Pediatr. 2018 Sep 1;172(9):818-823. doi: 10.1001/jamapediatrics.2018.1208.
• Raghuraman N, Temming LA, Doering MM, Stoll CR, Palanisamy A, Stout MJ, Colditz GA, Cahill AG, Tuuli MG. Maternal Oxygen Supplementation Compared With Room Air for Intrauterine Resuscitation: A Systematic Review and Meta-analysis. JAMA Pediatr. 2021 Apr 1;175(4):368-376. doi: 10.1001/jamapediatrics.2020.5351.
• Zhou S, Zhou Y, Cao X, Ni X, Du W, Xu Z, Liu Z. The efficacy of high flow nasal oxygenation for maintaining maternal oxygenation during rapid sequence induction in pregnancy: A prospective randomised clinical trial. Eur J Anaesthesiol. 2021 Oct 1;38(10):1052-1058. doi: 10.1097/EJA.0000000000001395.
• Zhou S, Cao X, Zhou Y, Xu Z, Liu Z. Ultrasound Assessment of Gastric Volume in Parturients After High-Flow Nasal Oxygen Therapy. Anesth Analg. 2023 Jul 1;137(1):176-181. doi: 10.1213/ANE.0000000000006340. Epub 2023 Jan 11.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2023
• Primary Completion (Actual): December 31, 2023
• Study Completion (Actual): December 31, 2023

Study Registration Dates

• First Submitted: June 15, 2023
• First Submitted That Met QC Criteria: June 25, 2023
• First Posted (Actual): June 27, 2023

Study Record Updates

• Last Update Posted (Estimated): January 26, 2024
• Last Update Submitted That Met QC Criteria: January 25, 2024
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: cesarean section; oxygen; high-flow nasal oxygen; umbilical artery; acidemia
• Additional Relevant MeSH Terms: Metabolic Diseases; Acid-Base Imbalance; Acidosis
• Other Study ID Numbers: TREC2023-KY021

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No