Back to resultsApplication of High-flow Nasal Oxygen in Cesarean Section
Primary Purpose
Fetal Acidemia
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Optiflow high-flow nasal cannula system
Sponsored by
About this trial
This is an interventional treatment trial for Fetal Acidemia focused on measuring high-flow nasal oxygen, cesarean section, oxygen, umbilical artery, acidemia
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
Sites / Locations
- Beijing tongren Hospital, Capital Medical UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
air group
HFNO group
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
umbilical artery lactate, mmol/L
mmol/L
Secondary Outcome Measures
umbilical artery pH value
unitless
umbilical artery oxygen partial pressure(PO2)
mmHg
umbilical artery partial pressure of carbon dioxide(PCO2)
mmHg
umbilical artery base excess(BE), mmol/L
mmol/L
the incidence of pH<7.20 and pH<7.10
percentage
Full Information
NCT ID
NCT05921955
First Posted
June 15, 2023
Last Updated
August 18, 2023
Sponsor
Beijing Tongren Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05921955
Brief Title
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
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2023 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Beijing Tongren Hospital
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fetal Acidemia
Keywords
high-flow nasal oxygen, cesarean section, oxygen, umbilical artery, acidemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
air group
Arm Type
No Intervention
Arm Description
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.
Arm Title
HFNO group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Optiflow high-flow nasal cannula system
Intervention Description
Using the Optiflow high-flow nasal cannula system to supply oxygen for maternal.
Primary Outcome Measure Information:
Title
umbilical artery lactate, mmol/L
Description
mmol/L
Time Frame
the fetal delivery
Secondary Outcome Measure Information:
Title
umbilical artery pH value
Description
unitless
Time Frame
the fetal delivery
Title
umbilical artery oxygen partial pressure(PO2)
Description
mmHg
Time Frame
the fetal delivery
Title
umbilical artery partial pressure of carbon dioxide(PCO2)
Description
mmHg
Time Frame
the fetal delivery
Title
umbilical artery base excess(BE), mmol/L
Description
mmol/L
Time Frame
the fetal delivery
Title
the incidence of pH<7.20 and pH<7.10
Description
percentage
Time Frame
the fetal delivery
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
yunhui Li
Phone
0086-15010607609
Email
yunhuil@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
guyan Wang
Organizational Affiliation
Beijing Tongren Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Beijing tongren Hospital, Capital Medical University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
yunhui Li
Phone
0086-15010607609
Email
yunhuil@126.com
12. IPD Sharing Statement
Citations:
PubMed Identifier
33394020
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.
Results Reference
background
PubMed Identifier
28224745
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.
Results Reference
background
PubMed Identifier
30039159
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.
Results Reference
background
PubMed Identifier
36630297
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.
Results Reference
background
PubMed Identifier
33259452
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.
Results Reference
background
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Application of High-flow Nasal Oxygen in Cesarean Section
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