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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
Sponsor:
Collaborator:
Bezmialem Vakif University
Information provided by (Responsible Party):
Duzce University

Brief Summary:

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

  Show Detailed Description

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Study Type : Observational
Actual Enrollment : 58 participants
Observational Model: Case-Control
Time Perspective: Prospective
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

Group/Cohort
Group 5PEEP
Administered 5 cmH2O positive end expiratory pressure group( Group 5PEEP n=30).
Group ZEEP
no positive end expiratory pressure group (Group ZEEP n=30)



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
60 morbidly obese patients which planned sleeve gastrectomy procedures under general anesthesia (ASA 2-3 status) were included in this study. Patients were devided into 2 groups which was ventileted with no positive end expiratory pressure(Group 5PEEP n=30), and 5 cmH2O positive and expiratory pressure (Group ZEEP n=30). All the patients were right hand dominate.
Criteria

Inclusion Criteria:

  • morbidly obese patients
  • planned sleeve gastrectomy procedures under general anesthesia
  • ASA 2-3 status
  • 18-60 years old

Exclusion Criteria:

  • Documented coronary or periferal arterial disease,
  • Unregulated diabetes mellitus,
  • History of smoking,
  • Symptoms of bowel or urinary bladder obstruction,
  • Preoperative systolic pressure grater than 170 mmHg,
  • Diastolic arterial pressure grater than 90mmHg,
  • Pregnancy,
  • Anemia (haematocrit levels under %30),
  • Symptoms of increased intracranial pressure,
  • Significant stenosis of the carotid arteries.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02920138


Locations
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Turkey
Duzce Univercity Medical Fauculty
Duzce, Turkey, 81600
Sponsors and Collaborators
Duzce University
Bezmialem Vakif University
Investigators
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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