Application of High-flow Nasal Oxygen in Cesarean Section

Fetal Acidemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05921955
• Other study ID #: TREC2023-KY021
• Status: Completed
• Phase: N/A
• Start date: July 1, 2023
• Est. completion date: December 31, 2023

Study information

• Verified date: April 2023
• Source: Beijing Tongren Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Acidosis
• Fetal Acidemia

Intervention

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

Locations

Country	Name	City	State
China	Beijing tongren Hospital, Capital Medical University	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Tongren Hospital

Country where clinical trial is conducted

China, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	umbilical artery lactate, mmol/L	mmol/L	the fetal delivery
Secondary	umbilical artery pH value	unitless	the fetal delivery
Secondary	umbilical artery oxygen partial pressure(PO2)	mmHg	the fetal delivery
Secondary	umbilical artery partial pressure of carbon dioxide(PCO2)	mmHg	the fetal delivery
Secondary	umbilical artery base excess(BE), mmol/L	mmol/L	the fetal delivery
Secondary	the incidence of pH<7.20 and pH<7.10	percentage	the fetal delivery