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

NCT02071550 | Completed

• 1 other identifier: 10869
• Study Type: observational
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Laparoscopic Cholecystectomy

Keywords

laparoscopic cholecystectomy, near infrared spectroscopy, positive end expiratory pressure

Outcome Measures

Primary Outcomes (1)

• change in cerebral oxymetry during laparoscopy

  1 day

Study Arms (2)

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

Interventions

FORESİGHT cerebral oxygen monitor and INVOS cerebral oxygen monitor DEVICE

10 CM H2O PEEP; zero PEEP

FORESIGHT and INVOS monitor DEVICE

10 CM H2O PEEP; zero PEEP

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients undergoing laparoscopic cholecystectomy

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Turkiye Yuksek Ihtisas Education and Research Hospital: lead

Study Sites (1)

Turkey Yuksek Ihtisas Education and Research Hospital, Anesthesiology Clinic

Ankara, 06550, Turkey (Türkiye)

Location

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associated professor

Study Record Dates

• First Submitted: February 18, 2014
• First Posted: February 26, 2014
• Study Start: August 1, 2013
• Primary Completion: December 1, 2013
• Last Updated: February 26, 2014

Record last verified: 2014-02

Locations

TU (1)