10cmH2O Peep Application and Cerebral Oxygenation in Laparoscopic Surgery: a Comparative Study With Invos and Foresight Devices (NIRS AND PEEP)

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.

Study Overview

• Status: Completed
• Conditions: Laparoscopic Cholecystectomy
• Intervention / Treatment: Device: FORESİGHT cerebral oxygen monitor and INVOS cerebral oxygen monitor; Device: FORESIGHT and INVOS monitor

• Study Type: Observational
• Enrollment (Actual): 44

Contacts and Locations

Study Locations

• Turkey
  • Ankara, Turkey, 06550
    • Turkey Yuksek Ihtisas Education and Research Hospital, Anesthesiology Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients undergoing laparoscopic cholecystectomy

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
zero PEEP; Patients undergoing laparoscopic cholecystectomy and monitorized with FORESIGHT,INVOS monitor	Device: FORESİGHT cerebral oxygen monitor and INVOS cerebral oxygen monitor; Device: FORESIGHT and INVOS monitor
10 CM H2O PEEP; Patients undergoing laparoscopic cholecystectomy and monitorized with FORESIGHT,INVOS monitor	Device: FORESİGHT cerebral oxygen monitor and INVOS cerebral oxygen monitor; Device: FORESIGHT and INVOS monitor

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
change in cerebral oxymetry during laparoscopy	1 day

Collaborators and Investigators

• Sponsor: Turkiye Yuksek Ihtisas Education and Research Hospital

Study record dates

Study Major Dates

• Study Start: August 1, 2013
• Primary Completion (Actual): December 1, 2013

Study Registration Dates

• First Submitted: February 18, 2014
• First Submitted That Met QC Criteria: February 21, 2014
• First Posted (Estimate): February 26, 2014

Study Record Updates

• Last Update Posted (Estimate): February 26, 2014
• Last Update Submitted That Met QC Criteria: February 21, 2014
• Last Verified: February 1, 2014

More Information

Terms related to this study

• Keywords: laparoscopic cholecystectomy, near infrared spectroscopy, positive end expiratory pressure
• Other Study ID Numbers: 10869