Cesarean Delivery Affecting NewbornNCT03903003
Preoperative Highflow Nasal Oxygen Application in Cesarean Under General Anesthesia and Its Effects on Newborn.
A study testing high flow nasal oxygen device (POİNT) and Face mask in people with Cesarean Delivery Affecting Newborn, run by Kocaeli Derince Education and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Preoperative Highflow Nasal Oxygen Application in Cesarean Under General Anesthesia and Its Effects on Newborn. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cesarean Delivery Affecting Newborn
- What is being tested?
- high flow nasal oxygen device (POİNT) and Face mask
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2019to 31 Dec 2019
- 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 80 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- over 18 years old;
- Patients undergoing elective ceserian operation
Who cannot join
- Patients who refuse to participate in the study;
- Patients under emergency conditions.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kocaeli Derince Education and Research Hospital
Kocaeli, 41400
About this study
Official title: In the Study; Preoperative Highflow Nasal Oxygen Application in Cesarean Under General Anesthesia and Its Effects on Newborn.
Preoperative Highflow Nasal Oxygen Application in Cesarean Under General Anesthesia and Its Effects on Newborn.
Read the detailed description
Patients who will undergo caesarean section under general anesthesia will be included in the study.
In the study; preoxygenation is applied to the caesarean sections under general anesthesia in two ways. Group1 includes preoxygenation masked patients.
- Conditions
- Cesarean Delivery Affecting Newborn
- Being tested
- high flow nasal oxygen device (POİNT), Face mask
- Keywords
- high flow nasal oxygen (POİNT)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
high flow nasal oxygen device (POİNT)Device
With POINT device (peri-operative insufflatory nasal therapy); patients are heated at higher flow and applied to humidified oxygen.
Face maskDevice
In order to protect the mother from hypoxia, preoxygenation is performed with face mask before induction of anesthesia.
| Study group | Role | What they receive |
|---|---|---|
| preoxygenation mask applied to the cesarean | Active comparator | In order to protect the mother from hypoxia, preoxygenation is performed with face mask before induction of anesthesia. Receives: Device: Face mask |
| high flow nasal oxygenation applied to the ceserian | Active comparator | In order to protect the mother from hypoxia, preoxygenation is performed with high flow nasal oxygenation mask before induction of anesthesia. Receives: Device: high flow nasal oxygen device (POİNT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
durations of stay
compare the durations of stay in the intensive care unit and in hospital
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2019
- Study start1 Jan 2019
- Primary completion8 Mar 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cesarean Delivery Affecting NewbornStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kocaeli Derince Education and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, EMİNE YURT, Kocaeli Derince Education and Research Hospital
- Investigators
- Mehmet Yılmaz, Study director, HEALTH AND SCİENCE UNIVERSITY MEDICAL SCHOOL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03903003
- Sponsor's protocol ID
- KIA 2018/506
- Status last verified
- Mar 2021
- First submitted
- 3 Apr 2019
- Last updated
- 16 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In the Study; Preoperative Highflow Nasal Oxygen Application in Cesarean Under General Anesthesia and Its Effects on Newborn.
- ClinicalTrials.gov ID
- NCT03903003
- Acronym / sponsor ID
- KIA 2018/506
- Conditions
- Cesarean Delivery Affecting Newborn
- Keywords
- high flow nasal oxygen (POİNT)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Kocaeli Derince Education and Research HospitalUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 8 Mar 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 4 Apr 2019 (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.
Preoperative Highflow Nasal Oxygen Application in Cesarean Under General Anesthesia and Its Effects on Newborn.
Detailed description
Patients who will undergo caesarean section under general anesthesia will be included in the study.
In the study; preoxygenation is applied to the caesarean sections under general anesthesia in two ways. Group1 includes preoxygenation masked patients.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| preoxygenation mask applied to the cesarean | Active comparator | Device: Face maskIn order to protect the mother from hypoxia, preoxygenation is performed with face mask before induction of anesthesia. |
| high flow nasal oxygenation applied to the ceserian | Active comparator | Device: high flow nasal oxygen device (POİNT)In order to protect the mother from hypoxia, preoxygenation is performed with high flow nasal oxygenation mask before induction of anesthesia. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- over 18 years old;
- Patients undergoing elective ceserian operation
Key exclusion criteria (2 listed)
- Patients who refuse to participate in the study;
- Patients under emergency conditions.
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 |
|---|---|---|
| high flow nasal oxygen device (POİNT)With POINT device (peri-operative insufflatory nasal therapy); patients are heated at higher flow and applied to humidified oxygen. | Device | high flow nasal oxygenation applied to the ceserian |
| Face maskIn order to protect the mother from hypoxia, preoxygenation is performed with face mask before induction of anesthesia. | Device | preoxygenation mask applied to the cesarean |
Primary outcome
durations of stay
Time frame: 24 hours
compare the durations of stay in the intensive care unit and in hospital
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 16 Mar 2021.
- Individual participant dataSharing planned: Undecided
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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.
Mehmet Yılmaz study director
HEALTH AND SCİENCE UNIVERSITY MEDICAL SCHOOL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing high flow nasal oxygen device (POİNT) and Face mask in people with Cesarean Delivery Affecting Newborn, run by Kocaeli Derince Education and Research Hospital 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 2 inclusion and 2 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 16 Mar 2021. 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?
durations of stay (time frame: 24 hours). 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 16 Mar 2021.