- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05392478
The Effects of Body Mass İndex On İntraabdominal Pressure And Regional Cerebral Oxygen Saturation İn Prone Position
May 23, 2022 updated by: Ozlem Sen, Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
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.
Study Overview
Status
Completed
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 Type
Observational
Enrollment (Actual)
40
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
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
Description
Inclusion Criteria:
- Age 18-70 years
- ASA physical status I - III patients undergoing lumbar disc hernia repair for two or less levels
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Other
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
İntraoperatif ( During surgery)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Özlem Şen, Trabzon Kanuni Training and Research Hospital
- Study Chair: Dilek Kalaycı, Dr.Abdurrahman Yurtaslan Oncology Training and Research Hospital
- Study Chair: Süheyla Ünver, Dr.Abdurrahman Yurtaslan Oncology Training and Research Hospita
- Study Chair: Tülay Dal, Dr.Abdurrahman Yurtaslan Oncology Training and Research Hospita
- Study Chair: Kübra Kutay, Bağcılar Training and Research Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 10, 2014
Primary Completion (Actual)
September 1, 2014
Study Completion (Actual)
October 1, 2014
Study Registration Dates
First Submitted
May 23, 2022
First Submitted That Met QC Criteria
May 23, 2022
First Posted (Actual)
May 26, 2022
Study Record Updates
Last Update Posted (Actual)
May 26, 2022
Last Update Submitted That Met QC Criteria
May 23, 2022
Last Verified
May 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2182NIRS
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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