Clinical trial NCT05921955: Application of High-flow Nasal Oxygen in Cesarean Section
Official title: Effect of Maternal Oxygen Supplementation by High-flow Nasal Oxygen Compared With Room Air on Fetal Acidemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fetal Acidemia
Keywords: high-flow nasal oxygen
cesarean section
oxygen
umbilical artery
acidemia
Lead sponsor: Beijing Tongren Hospital
Sponsor class: OTHER
First posted: 2023-06-27
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: umbilical artery lactate, mmol/L
timeFrame: the fetal delivery
Secondary outcomes:
measure: umbilical artery pH value
timeFrame: the fetal delivery
measure: umbilical artery oxygen partial pressure(PO2)
timeFrame: the fetal delivery
measure: umbilical artery partial pressure of carbon dioxide(PCO2)
timeFrame: the fetal delivery
measure: umbilical artery base excess(BE), mmol/L
timeFrame: the fetal delivery
measure: the incidence of pH<7.20 and pH<7.10
timeFrame: the fetal delivery
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing tongren Hospital, Capital Medical University
state: Beijing
Study officials:
affiliation: Beijing Tongren Hospital
name: guyan Wang
role: STUDY_DIRECTOR
References:
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.
citation: 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.
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.
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.
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.