The Effect of PEEP and Intraabdominal Pressure Levels on Cerebral Oxygenation Morbidly Obese.
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|ClinicalTrials.gov Identifier: NCT02920138|
Recruitment Status : Completed
First Posted : September 30, 2016
Last Update Posted : April 22, 2019
Background: Study was designed to determine the effect of zero (ZEEP) and 5 mmHg positive end expiratory pressure (5PEEP) on cerebral oximeter levels in morbid obese patients whose undergoing laparoscopic sleeve gastrectomy. Second outcome is to investigate the effect of intraabdominal pressure changes on cerebral oxygen values in LSG.
Method:18-65 yo, ASA2-3 status, 60 morbid obese patients which planned SLG under general anesthesia were included.Two patient in Group 5 PEEP were excluded because of the haemodynamic instability during procedure. Patients were divided into 2 groups which was ventilated with no PEEP (Group ZEEP)(n=30) and 5 cmH2O PEEP levels (Group5 PEEP)(n=28). All patients were use right hand dominant. Near infrared spectroscopy probes were applied to both frontal cerebral area of all patiens and measured rSO2 values. IAP were measured transvesically in all groups. Datas were recorded as basal, after induction of anesthesia, 5 minute before insufflation(5BI), 5 minute after insufflation(5BA), 15, 30, 45, 60 minute after induction, 5 minute before desufflation(5BD) and 5 minute after desufflation(5AD) time periods. Invasive arterial pressures, cerebral oxymeter values, 5 lead electrocardiography, peripheral oxygen saturation, end tidal carbondioxide, peak inspiratory pressures, intra abdominal pressure, were recorded time periods in all groups. Arterial blood sample analysed on 5BI,5AI, 5AD periods.
|Condition or disease|
|Unspecified Effect of Air Pressure|
|Study Type :||Observational|
|Actual Enrollment :||58 participants|
|Official Title:||The Effect of PEEP, Zero PEEP and Intraabdominal Pressure Levels on Cerebral Oxygenation (rso2) in the Morbidly Obese Undergoing Sleeve Gastrectomy|
|Study Start Date :||January 2014|
|Actual Primary Completion Date :||August 2016|
|Actual Study Completion Date :||August 2016|
Administered 5 cmH2O positive end expiratory pressure group( Group 5PEEP n=30).
no positive end expiratory pressure group (Group ZEEP n=30)
- cerebral oximeter [ Time Frame: 3 hours ]To determine the effect of zero PEEP (ZEEP) and 5 mmHg positive end expiratory pressure (5PEEP) on cerebral oximeter levels in morbid obese patients whose undergoing laporoscopic sleeve gastrectomy.
- IAP changes on cerebral oxygen values [ Time Frame: 3 hours ]Second outcome is to investigate the effect of intraabdominal pressure changes on cerebral oxygen values in LSG.
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02920138
|Duzce Univercity Medical Fauculty|
|Duzce, Turkey, 81600|
|Study Director:||İlknur S Şeker||Duzce University Faculty of Medicine Anesthesiology and Intensive Care Depth, Duzce, Turkey|
|Principal Investigator:||Yavuz Demiraran||Canakkale 18 Mart University, School of Medicine Department of Anesthesiology and Reanimation, Canakkale, Turkey|
|Principal Investigator:||Ziya Salihoğlu||Istanbul University Cerrahpaşa Medical Faculty, Anesthesiology and Intensive Care Depth, Istanbul, Turkey|
|Principal Investigator:||Tarık Umutoğlu||Bezmialem Vakif University, Faculty of Medicine, Anesthesiology and Intensive Care Depth, Istanbul, Turkey|
|Principal Investigator:||İsmet Özaydın||Duzce University Faculty of Medicine General Surgery Depth, Duzce, Turkey|
|Principal Investigator:||Sami Doğan||Duzce University Faculty of Medicine General Surgery Depth, Duzce, Turkey|