Application of High-flow Nasal Oxygen in Cesarean Section

NCT05921955 | Completed

• 1 other identifier: TREC2023-KY021
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Fetal Acidemia

Keywords

high-flow nasal oxygen; cesarean section; oxygen; umbilical artery; acidemia

Outcome Measures

Primary Outcomes (1)

• umbilical artery lactate, mmol/L

  mmol/L

  the fetal delivery

Secondary Outcomes (5)

• umbilical artery pH value

  the fetal delivery

• umbilical artery oxygen partial pressure(PO2)

  the fetal delivery

• umbilical artery partial pressure of carbon dioxide(PCO2)

  the fetal delivery

• umbilical artery base excess(BE), mmol/L

  the fetal delivery

• the incidence of pH<7.20 and pH<7.10

  the fetal delivery

Study Arms (2)

air group

NO INTERVENTION

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.

HFNO group

EXPERIMENTAL

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

Interventions

Optiflow high-flow nasal cannula system DEVICE

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

HFNO group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Beijing Tongren Hospital: lead

Study Sites (1)

Beijing tongren Hospital, Capital Medical University

Beijing, Beijing Municipality, 100000, China

Location

Related Publications (6)

• 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.

  PMID: 33394020 BACKGROUND

• 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.

  PMID: 28224745 BACKGROUND

• 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.

  PMID: 30039159 BACKGROUND

• 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.

  PMID: 36630297 BACKGROUND

• 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.

  PMID: 33259452 BACKGROUND

• Li YH, Lei GY, Guo J, Yi M, Fu YJ, Wang GY. Effect of maternal oxygen supplementation for parturient undergoing elective cesarean section by high-flow nasal oxygen compared with room air on fetal acidemia: study protocol for a randomized controlled trial. Trials. 2024 Jan 22;25(1):73. doi: 10.1186/s13063-024-07927-y.

  PMID: 38254137 DERIVED

Study Officials

• guyan Wang

  Beijing Tongren Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2023
• First Posted: June 27, 2023
• Study Start: July 1, 2023
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: January 26, 2024

Record last verified: 2023-04

Locations

CN (1)