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

Laparoscopic Cholecystectomy Clinical Trial

— NIRS AND PEEP  

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02071550
• Other study ID #: 10869
• Status: Completed
• Phase: N/A
• First received: February 18, 2014
• Last updated: February 21, 2014
• Start date: August 2013

Study information

• Verified date: February 2014
• Source: Turkiye Yuksek Ihtisas Education and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ministry of Health
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Laparoscopic Cholecystectomy

Intervention

Device:
• FORESIGHT cerebral oxygen monitor and INVOS cerebral oxygen monitor

• FORESIGHT and INVOS monitor

Locations

Country	Name	City	State
Turkey	Turkey Yuksek Ihtisas Education and Research Hospital, Anesthesiology Clinic	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Turkiye Yuksek Ihtisas Education and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in cerebral oxymetry during laparoscopy		1 day	Yes