HypoxiaNCT05395975
Different Preoxygenation Methods In Cesarean Section
An observational study of Hypoxia and Hyperoxia, run by Zonguldak Bulent Ecevit University at 1 site in Turkey (Türkiye).
Trial summary
The study aimed to evaluate different preoxygenation methods (tidal volume for 3 minutes and 4 deep breaths) in pregnant women with oxygen reserve index (ORI). After the routine monitoring of healthy ASA II pregnant patients between the ages of 18-45, different preoxygenation methods will be applied, and the oxygen… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- What is being tested?
- Oxygen Reserve Index
- Type of treatment
- Medical device
- How many people
- 1 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2020to 31 Dec 2021
- Phase
- Observational
- 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
Study population: Patients aged 18-45 who had cesarean section under general anesthesia
Who may be able to join
- The average operation time is 30 minutes-1.5 hours.
- ASA II risk class
- All pregnant women with a gestational week >36
Who cannot join
- preeclampsia
- eclampsia
- fetal distress
- morbid obesity
- a history of malignant hyperthermia
- opioid sensitivity
Show all 13Show fewer
- alcohol or drug addiction
- congestive heart failure
- chronic obstructive pulmonary disease
- coronary artery disease
- anemia, liver and kidney disease
- hypovolemia, hypotension, sepsis
- Those who are allergic to the drugs used in the study and who are suspected of difficult intubation
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Zonguldak Bülent Ecevit University Faculty of Medicine
Zonguldak, Kozlu, 67600
About this study
Official title: Assessment of Different Preoxygenation Methods With Oxygen Reserve Index In Cesarean Section
The study aimed to evaluate different preoxygenation methods (tidal volume for 3 minutes and 4 deep breaths) in pregnant women with oxygen reserve index (ORI).
After the routine monitoring of healthy ASA II pregnant patients between the ages of 18-45, different preoxygenation methods will be applied, and the oxygen status of the patients will be compared with ORI monitoring.
- Being tested
- Oxygen Reserve Index
- Keywords
- Oxygen Reserve Index, Preoxygenation, General Anesthesia, Cesarean Section
- Medical subject headings
- Hypoxia, Hyperoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oxygen Reserve IndexDevice
It is a new non-invasive and continuous measurement parameter that aims to provide information about the oxygen status of patients in the moderately hyperoxic range (100 mmHg< PaO2 ≤ 200 mmHg).
| Study group | Role | What they receive |
|---|---|---|
| Group I | Preoxygenation with 100% oxygen for 3 minutes Receives: Device: Oxygen Reserve Index | |
| Group II | 4 deep breaths with 100% oxygen in 30 seconds Receives: Device: Oxygen Reserve Index |
What is being measured
The primary outcome is the main question the study is designed to answer.
Preoxygenation Methods
Effects of Different Preoxygenation Methods on SaO2, FiO2 and FeO2 with Oxygen Reserve Index
Measured: During the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2022
- Study start1 Dec 2020
- Primary completion27 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypoxiaStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zonguldak Bulent Ecevit University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05395975
- Sponsor's protocol ID
- 2020/22-24
- Status last verified
- Nov 2020
- First submitted
- 12 May 2022
- Last updated
- 27 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Different Preoxygenation Methods With Oxygen Reserve Index In Cesarean Section
- ClinicalTrials.gov ID
- NCT05395975
- Acronym / sponsor ID
- 2020/22-24
- Keywords
- Oxygen Reserve Index, Preoxygenation, General Anesthesia, Cesarean Section
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Zonguldak Bulent Ecevit UniversityUniversity, hospital or other
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 27 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 27 May 2022 (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 aimed to evaluate different preoxygenation methods (tidal volume for 3 minutes and 4 deep breaths) in pregnant women with oxygen reserve index (ORI).
After the routine monitoring of healthy ASA II pregnant patients between the ages of 18-45, different preoxygenation methods will be applied, and the oxygen status of the patients will be compared with ORI monitoring.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I | – | Device: Oxygen Reserve IndexPreoxygenation with 100% oxygen for 3 minutes |
| Group II | – | Device: Oxygen Reserve Index4 deep breaths with 100% oxygen in 30 seconds |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Patients aged 18-45 who had cesarean section under general anesthesia
Key inclusion criteria (3 listed)
- The average operation time is 30 minutes-1.5 hours.
- ASA II risk class
- All pregnant women with a gestational week >36
Key exclusion criteria (13 listed)
- preeclampsia
- eclampsia
- fetal distress
- morbid obesity
- a history of malignant hyperthermia
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 |
|---|---|---|
| Oxygen Reserve IndexIt is a new non-invasive and continuous measurement parameter that aims to provide information about the oxygen status of patients in the moderately hyperoxic range (100 mmHg< PaO2 ≤ 200 mmHg). | Device | Group I, Group II |
Primary outcome
Preoxygenation Methods
Time frame: During the surgery
Effects of Different Preoxygenation Methods on SaO2, FiO2 and FeO2 with Oxygen Reserve Index
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 27 May 2022.
- Individual participant dataSharing planned: Yes
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypoxia and Hyperoxia, run by Zonguldak Bulent Ecevit University at 1 site in Turkey (Türkiye).
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 3 inclusion and 13 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 27 May 2022. 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 Turkey (Türkiye). 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?
Preoxygenation Methods (time frame: During the surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 May 2022.