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

Completed

• Conditions: Laparoscopic Cholecystectomy
• Interventions: Device: FORESİGHT cerebral oxygen monitor and INVOS cerebral oxygen monitor; Device: FORESIGHT and INVOS monitor

• Registration Number: NCT02071550
• Lead Sponsor: Turkiye Yuksek Ihtisas Education and Research Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-08
• Primary Completion: 2013-12
• Status Verified: 2014-02
• Study First Submitted: 2014-02-18
• Study First Submitted QC: 2014-02-21
• Last Update Submitted: 2014-02-21
• Study First Posted: 2014-02-26
• Last Update Posted: 2014-02-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
zero PEEP	FORESİGHT cerebral oxygen monitor and INVOS cerebral oxygen monitor	Patients undergoing laparoscopic cholecystectomy and monitorized with FORESIGHT,INVOS monitor
zero PEEP	FORESIGHT and INVOS monitor	Patients undergoing laparoscopic cholecystectomy and monitorized with FORESIGHT,INVOS monitor
10 CM H2O PEEP	FORESİGHT cerebral oxygen monitor and INVOS cerebral oxygen monitor	Patients undergoing laparoscopic cholecystectomy and monitorized with FORESIGHT,INVOS monitor
10 CM H2O PEEP	FORESIGHT and INVOS monitor	Patients undergoing laparoscopic cholecystectomy and monitorized with FORESIGHT,INVOS monitor

Primary Outcome Measures

Name	Time	Method
change in cerebral oxymetry during laparoscopy	1 day

Trial Locations

Locations (1)

Turkey Yuksek Ihtisas Education and Research Hospital, Anesthesiology Clinic; 🇹🇷 Ankara, Turkey