Cerebral Hypoxia During and/or Resulting From A ProcedureNCT05392478
The Effects of Body Mass İndex On İntraabdominal Pressure And Regional Cerebral Oxygen Saturation İn Prone Position
An observational study of Cerebral Hypoxia During and/or Resulting From A Procedure, run by Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital.
Trial summary
A total of 40 ASA (American Society of Anesthesiology) physical status I-III who underwent lumbar disc hernia repair for one or two levels were included in this prospective study. A standard anesthesia protocol was performed in all patients. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Cerebral Hypoxia During and/or Resulting From A Procedure
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 10 Mar 2014to Oct 2014
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 40 ASA physical status I - III patients undergoing lumbar disc hernia repair for two or less levels. The ethical committee approval for the study was taken from the Abdurrahman Yurtaslan Oncology Training and Research Hospital (2014-2182). The informed consent was obtained for all the patients that were included in the study
Who may be able to join
- Age 18-70 years
- ASA physical status I - III patients undergoing lumbar disc hernia repair for two or less levels
Who cannot join
- Age smaller than 18 or older than 70 years,
- ASA physical status more than III,
- Patients with a history of carotid artery stenosis, prior neck surgery, cervical canal stenosis, stroke, neurological deficit, myocardial infarction, spinal cord injury and sudden vision loss
About this study
Official title: The Effects of Body Mass İndex On İntraabdominal Pressure And Regional Cerebral Oxygen Saturation İn Lumbar Spine Surgery İn Prone Position
A total of 40 ASA (American Society of Anesthesiology) physical status I-III who underwent lumbar disc hernia repair for one or two levels were included in this prospective study. A standard anesthesia protocol was performed in all patients. Routine intraoperative monitoring consisted of electrocardiography, automatic noninvasive arterial blood pressure, pulse oximetry, capnography, and cerebral tissue oxygen saturation through NIRS.Patients' demographics such as age, gender, height, weight, BMI, smoking status and pre-existing medical conditions were recorded.The patients were allocated equally to two groups according to BMI as Group I: BMI ≥30kg/m2,Group II <30 kg/m2.
Read the detailed description
Routine intraoperative monitoring consisted of electrocardiography, automatic noninvasive arterial blood pressure, pulse oximetry, capnography, and cerebral tissue oxygen saturation through NIRS.Frontal lobe oxygenation was monitored continuously and recorded every 5 minutes.Before positioning patients on the operating table, a Foley catheter was placed. IAP was measured in the following positions in all patients: 1) in the supine position after intubation 2) in the prone position before the skin incision.All patients were placed into the prone position on the silicone pads after general anesthesia.Before statistical analysis, the 40 patients were allocated equally to two groups according to the World Health Organization Guideline of BMI: Group I: BMI ≥30kg/m2, Group II <30 kg/m2
- Keywords
- cerebral oxygenation, prone position, obesity
- Medical subject headings
- Obesity
What is being measured
The primary outcome is the main question the study is designed to answer.
Cerebral tissue oxygen saturation with NIRS .Effect os boddy mass index on cerebral tissue oxygen saturation in prone position
Effects of boddy mass index and intraabdominal pressure on cerebral tissue oxygen saturation in prone position
Measured: İntraoperatif ( During surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2022
- Study start10 Mar 2014
- Primary completionSep 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral Hypoxia During and/or Resulting From A ProcedureStudies 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-control
- Time perspective
- Other
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ozlem Sen, Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
- Investigators
- Özlem Şen, Principal investigator, Trabzon Kanuni Training and Research HospitalDilek Kalaycı, Study chair, Dr.Abdurrahman Yurtaslan Oncology Training and Research HospitalSüheyla Ünver, Study chair, Dr.Abdurrahman Yurtaslan Oncology Training and Research HospitaTülay Dal, Study chair, Dr.Abdurrahman Yurtaslan Oncology Training and Research HospitaKübra Kutay, Study chair, Bağcılar Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05392478
- Sponsor's protocol ID
- 2182NIRS
- Status last verified
- May 2022
- First submitted
- 23 May 2022
- Last updated
- 26 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Body Mass İndex On İntraabdominal Pressure And Regional Cerebral Oxygen Saturation İn Lumbar Spine Surgery İn Prone Position
- ClinicalTrials.gov ID
- NCT05392478
- Acronym / sponsor ID
- 2182NIRS
- Keywords
- cerebral oxygenation, prone position, obesity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research HospitalUniversity, hospital or other
- Study start
- 10 Mar 2014 (actual)
- Primary completion
- Sep 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 26 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.
A total of 40 ASA (American Society of Anesthesiology) physical status I-III who underwent lumbar disc hernia repair for one or two levels were included in this prospective study. A standard anesthesia protocol was performed in all patients. Routine intraoperative monitoring consisted of electrocardiography, automatic noninvasive arterial blood pressure, pulse oximetry, capnography, and cerebral tissue oxygen saturation through NIRS.Patients' demographics such as age, gender, height, weight, BMI, smoking status and pre-existing medical conditions were recorded.The patients were allocated equally to two groups according to BMI as Group I: BMI ≥30kg/m2,Group II <30 kg/m2.
Detailed description
Routine intraoperative monitoring consisted of electrocardiography, automatic noninvasive arterial blood pressure, pulse oximetry, capnography, and cerebral tissue oxygen saturation through NIRS.Frontal lobe oxygenation was monitored continuously and recorded every 5 minutes.Before positioning patients on the operating table, a Foley catheter was placed. IAP was measured in the following positions in all patients: 1) in the supine position after intubation 2) in the prone position before the skin incision.All patients were placed into the prone position on the silicone pads after general anesthesia.Before statistical analysis, the 40 patients were allocated equally to two groups according to the World Health Organization Guideline of BMI: Group I: BMI ≥30kg/m2, Group II <30 kg/m2
Study design
- Observational model
- Case-control
- Time perspective
- Other
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 40 ASA physical status I - III patients undergoing lumbar disc hernia repair for two or less levels. The ethical committee approval for the study was taken from the Abdurrahman Yurtaslan Oncology Training and Research Hospital (2014-2182). The informed consent was obtained for all the patients that were included in the study
Key inclusion criteria (2 listed)
- Age 18-70 years
- ASA physical status I - III patients undergoing lumbar disc hernia repair for two or less levels
Key exclusion criteria (3 listed)
- Age smaller than 18 or older than 70 years,
- ASA physical status more than III,
- Patients with a history of carotid artery stenosis, prior neck surgery, cervical canal stenosis, stroke, neurological deficit, myocardial infarction, spinal cord injury and sudden vision loss
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
Cerebral tissue oxygen saturation with NIRS .Effect os boddy mass index on cerebral tissue oxygen saturation in prone position
Time frame: İntraoperatif ( During surgery)
Effects of boddy mass index and intraabdominal pressure on cerebral tissue oxygen saturation in prone position
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 May 2022.
Related trials for Cerebral Hypoxia During and/or Resulting From A Procedure
Active, not recruitingObservational study
Complications and Antiplatelet and Anticoagulant Therapy in Vascular Surgery.
Thrombosis, Bleeding
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.
Özlem Şen principal investigator
Trabzon Kanuni Training and Research Hospital
Dilek Kalaycı study chair
Dr.Abdurrahman Yurtaslan Oncology Training and Research Hospital
Süheyla Ünver study chair
Dr.Abdurrahman Yurtaslan Oncology Training and Research Hospita
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebral Hypoxia During and/or Resulting From A Procedure, run by Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital.
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 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: finished, as of the sponsor's last update on 26 May 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Cerebral tissue oxygen saturation with NIRS .Effect os boddy mass index on cerebral tissue oxygen saturation in prone position (time frame: İntraoperatif ( During 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 26 May 2022.