Tissue OxygenationNCT04187846
Postspinal Headache and Near Infrared Spectroscopy (NIRS)
An observational study of Tissue Oxygenation, run by Hakan Tapar at 1 site in Turkey (Türkiye).
Trial summary
Evaluation of the relationship between postspinal headache and near infrared spectroscopy in cesarean section patients Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Tissue Oxygenation
- How many people
- 200 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Mar 2019to 10 Mar 2020
- 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
- No healthy volunteers
- Adult
Study population: Patients with cesarean section under spinal anesthesia
Who may be able to join
- Elective cesarean section
Who cannot join
- Not willing to participate in the study
- Use of anti-psychotic or anti-depressant drugs
- Patients with headaches
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Gaziosmanpasa University
Tokat Province, 60200
Hakan Tapar, Assist.Prof., +905056844496, hakantapar@hotmail.com
About this study
Official title: Evaluation of the Relationship Between Postspinal Headache and Near Infrared Spectroscopy in Cesarean Section Patients
Evaluation of the relationship between postspinal headache and near infrared spectroscopy in cesarean section patients
Read the detailed description
Patients with cesarean section under spinal anesthesia were included in the study. Before the study, patients were moniterized with NIRS device in the preoperative waiting room.NIRS moniterization was continued intraoperatively at 1st, 4th, 7th, 10th, 15th, 30th minutes and 24th postoperative period.
Patients were divided into two groups as those with postspinal headache (Group A) and those with postspinal headache (Group B). In this study, NIRS values between two groups were compared.
- Conditions
- Tissue Oxygenation
- Keywords
- Cesarean section, post spinal headache, Near Infrared spectroscopy
- Medical subject headings
- Post-Dural Puncture Headache
What is being measured
The primary outcome is the main question the study is designed to answer.
Near Infrared spectroscopy
Tissue oxygenation
Measured: Up to 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2019
- Study start15 Mar 2019
- Primary completion30 Dec 2019 (estimated)
- Study completion10 Mar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tissue OxygenationStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hakan Tapar
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hakan Tapar, Tokat Gaziosmanpasa University
- Investigators
- Hakan Tapar, Principal investigator, Gaziosmanpasa University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04187846
- Sponsor's protocol ID
- 18-KAEK-167
- Status last verified
- Dec 2019
- First submitted
- 2 Dec 2019
- Last updated
- 5 Dec 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Relationship Between Postspinal Headache and Near Infrared Spectroscopy in Cesarean Section Patients
- ClinicalTrials.gov ID
- NCT04187846
- Acronym / sponsor ID
- 18-KAEK-167
- Conditions
- Tissue Oxygenation
- Keywords
- Cesarean section, post spinal headache, Near Infrared spectroscopy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Hakan TaparUniversity, hospital or other
- Study start
- 15 Mar 2019 (actual)
- Primary completion
- 30 Dec 2019 (estimated)
- Study completion
- 10 Mar 2020 (estimated)
- First posted
- 5 Dec 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.
Evaluation of the relationship between postspinal headache and near infrared spectroscopy in cesarean section patients
Detailed description
Patients with cesarean section under spinal anesthesia were included in the study. Before the study, patients were moniterized with NIRS device in the preoperative waiting room.NIRS moniterization was continued intraoperatively at 1st, 4th, 7th, 10th, 15th, 30th minutes and 24th postoperative period.
Patients were divided into two groups as those with postspinal headache (Group A) and those with postspinal headache (Group B). In this study, NIRS values between two groups were compared.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients with cesarean section under spinal anesthesia
Key inclusion criteria (1 listed)
- Elective cesarean section
Key exclusion criteria (3 listed)
- Not willing to participate in the study
- Use of anti-psychotic or anti-depressant drugs
- Patients with headaches
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Near Infrared spectroscopy
Time frame: Up to 20 weeks
Tissue oxygenation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2019.
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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.
Hakan Tapar principal investigator
Gaziosmanpasa University
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 Tissue Oxygenation, run by Hakan Tapar 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 1 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 5 Dec 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hakan Tapar (+905056844496, hakantapar@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Near Infrared spectroscopy (time frame: Up to 20 weeks). 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 5 Dec 2019.