Fetal AcidemiaNCT05921955
Application of High-flow Nasal Oxygen in Cesarean Section
A study testing Optiflow high-flow nasal cannula system in people with Fetal Acidemia, run by Beijing Tongren Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Fetal Acidemia
- What is being tested?
- Optiflow high-flow nasal cannula system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2023to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
Beijing tongren Hospital, Capital Medical University
Beijing, Beijing Municipality, 100000
About this study
Official title: 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.
Read the 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.
- Conditions
- Fetal Acidemia
- Being tested
- Optiflow high-flow nasal cannula system
- Keywords
- high-flow nasal oxygen, cesarean section, oxygen, umbilical artery, acidemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optiflow high-flow nasal cannula systemDevice
Using the Optiflow high-flow nasal cannula system to supply oxygen for maternal.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Optiflow high-flow nasal cannula system |
What is being measured
The primary outcome is the main question the study is designed to answer.
umbilical artery lactate, mmol/L
mmol/L
Measured: the fetal delivery
Secondary outcomes (5)
umbilical artery pH value
unitless
Measured: the fetal delivery
umbilical artery oxygen partial pressure(PO2)
mmHg
Measured: the fetal delivery
umbilical artery partial pressure of carbon dioxide(PCO2)
mmHg
Measured: the fetal delivery
umbilical artery base excess(BE), mmol/L
mmol/L
Measured: the fetal delivery
the incidence of pH<7.20 and pH<7.10
percentage
Measured: the fetal delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2023
- Study start1 Jul 2023
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Fetal AcidemiaStudies of the same condition, open and under way.
- More trials run by Beijing Tongren HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Tongren Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- guyan Wang, Study director, Beijing Tongren Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05921955
- Sponsor's protocol ID
- TREC2023-KY021
- Status last verified
- Apr 2023
- First submitted
- 15 Jun 2023
- Last updated
- 26 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 33394020Qian 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.
PubMed 28224745Raghuraman 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.
PubMed 30039159Zhou 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.
PubMed 36630297Zhou 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.
PubMed 33259452Lei G, Li Y, Guo J, Yi M, Fu Y, Wang G. Effect of maternal oxygen supplementation for parturients undergoing elective cesarean delivery by high-flow nasal oxygen compared with room air on fetal acid-base status: a randomized clinical trial. Int J Obstet Anesth. 2026 Aug;67:105207. doi: 10.1016/j.ijoa.2026.105207. Epub 2026 May 17.
PubMed 42361493Li 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.
PubMed 38254137
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Maternal Oxygen Supplementation by High-flow Nasal Oxygen Compared With Room Air on Fetal Acidemia
- ClinicalTrials.gov ID
- NCT05921955
- Acronym / sponsor ID
- TREC2023-KY021
- Conditions
- Fetal Acidemia
- Keywords
- high-flow nasal oxygen, cesarean section, oxygen, umbilical artery, acidemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Beijing Tongren HospitalUniversity, hospital or other
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 27 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Device: Optiflow high-flow nasal cannula systemFor 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Optiflow high-flow nasal cannula systemUsing the Optiflow high-flow nasal cannula system to supply oxygen for maternal. | Device | HFNO group |
Primary outcome
umbilical artery lactate, mmol/L
Time frame: the fetal delivery
mmol/L
5 secondary outcomes
umbilical artery pH value
Time frame: the fetal delivery
umbilical artery oxygen partial pressure(PO2)
Time frame: the fetal delivery
umbilical artery partial pressure of carbon dioxide(PCO2)
Time frame: the fetal delivery
umbilical artery base excess(BE), mmol/L
Time frame: the fetal delivery
the incidence of pH<7.20 and pH<7.10
Time frame: the fetal delivery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2024.
- Background: PubMed 33394020Raghuraman 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.
- Background: PubMed 28224745Qian 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.
- Background: PubMed 30039159Raghuraman 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.
- Background: PubMed 36630297Zhou 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.
- Background: PubMed 33259452Zhou 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.
- Derived from this study: PubMed 42361493Lei G, Li Y, Guo J, Yi M, Fu Y, Wang G. Effect of maternal oxygen supplementation for parturients undergoing elective cesarean delivery by high-flow nasal oxygen compared with room air on fetal acid-base status: a randomized clinical trial. Int J Obstet Anesth. 2026 Aug;67:105207. doi: 10.1016/j.ijoa.2026.105207. Epub 2026 May 17.
- Derived from this study: PubMed 38254137Li 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
guyan Wang study director
Beijing Tongren Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Optiflow high-flow nasal cannula system in people with Fetal Acidemia, run by Beijing Tongren Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
umbilical artery lactate, mmol/L (time frame: the fetal delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05921955, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2024.