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

NCT ID: NCT02071550

Last Updated: 2014-02-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

44 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Laparoscopic Cholecystectomy

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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zero PEEP

Patients undergoing laparoscopic cholecystectomy and monitorized with FORESIGHT,INVOS monitor

FORESİGHT cerebral oxygen monitor and INVOS cerebral oxygen monitor

Intervention Type DEVICE

FORESIGHT and INVOS monitor

Intervention Type DEVICE

10 CM H2O PEEP

Patients undergoing laparoscopic cholecystectomy and monitorized with FORESIGHT,INVOS monitor

FORESİGHT cerebral oxygen monitor and INVOS cerebral oxygen monitor

Intervention Type DEVICE

FORESIGHT and INVOS monitor

Intervention Type DEVICE

Interventions

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FORESİGHT cerebral oxygen monitor and INVOS cerebral oxygen monitor

Intervention Type DEVICE

FORESIGHT and INVOS monitor

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Turkiye Yuksek Ihtisas Education and Research Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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aslı demir

Associated professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Turkey Yuksek Ihtisas Education and Research Hospital, Anesthesiology Clinic

Ankara, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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10869

Identifier Type: -

Identifier Source: org_study_id

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