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Clinical Trials/NCT02071550
NCT02071550
Completed
Not Applicable

10cmH2O Peep Application and Cerebral Oxygenation in Laparoscopic Surgery: a Comparative Study With Invos and Foresight Devices

Turkiye Yuksek Ihtisas Education and Research Hospital1 site in 1 country44 target enrollmentAugust 2013

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Laparoscopic Cholecystectomy
Sponsor
Turkiye Yuksek Ihtisas Education and Research Hospital
Enrollment
44
Locations
1
Primary Endpoint
change in cerebral oxymetry during laparoscopy
Status
Completed
Last Updated
12 years ago

Overview

Brief Summary

In this study the investigators investigated changes in hemodynamic parameters and cerebral oxygen saturation (rSO2) associated with 10 cmH2O PEEP, which is assumed beneficial for the respiratory functions and oxygenation during the laparoscopic cholecystectomy (LC) applied at the 30°head-up left side position, is compared with using two individual devices (INVOS-FORESIGHT).

Methods: Afterwards the ethics committee approval of the hospital and receiving the written patients' consents, patients to undergo ASA I-II group elective laparoscopic surgery were randomly divided into two groups. Sensors of INVOS and FORESIGHT devices were placed on the right side forehead region. Totally 11 evaluation periods were formed, respectively: Pre-induction (1st Period), post-induction (2nd period), abdominal insufflation outset (3rd period): post-insufflation 5-minute intervals (4th, 5th, 6th, 7th 8th period), end of insufflation (9th period), end of operation (10th period) and end of anaesthesia (11th period). While one of the groups was not applied PEEP(ZEEP), the other group was applied 10 cmH2O simultaneously with the abdominal insufflation proceeding. Demographic data, hemodynamic values and rSO2 values were recorded for both groups at all 11 periods.

Registry
clinicaltrials.gov
Start Date
August 2013
End Date
December 2013
Last Updated
12 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Turkiye Yuksek Ihtisas Education and Research Hospital
Responsible Party
Principal Investigator
Principal Investigator

aslı demir

Associated professor

Turkiye Yuksek Ihtisas Education and Research Hospital

Eligibility Criteria

Inclusion Criteria

  • ASA(American Society of Anesthesiologist) class I and II
  • Patients undergoing laparoscopic cholecystectomy

Exclusion Criteria

  • ASA class III and IV
  • Morbid obesity
  • Emergency cases
  • Cases returned to laparotomy

Outcomes

Primary Outcomes

change in cerebral oxymetry during laparoscopy

Time Frame: 1 day

Study Sites (1)

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