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OpenTrials
Completed

NCT Number: NCT02071550

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Turkey Yuksek Ihtisas Education and Research Hospital, Anesthesiology Clinic

Ankara, 06550, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

FORESİGHT cerebral oxygen monitor and INVOS cerebral oxygen monitor

Device

FORESIGHT and INVOS monitor

Device

Primary outcomes

  1. change in cerebral oxymetry during laparoscopy

    Time frame: 1 day

Sponsors and collaborators

Lead sponsor

Turkiye Yuksek Ihtisas Education and Research Hospital

Other Gov

Registry information

Acronym: NIRS AND PEEP

Important dates

Study start
2013
Primary completion
2013
First posted
Feb 26, 2014
Registry last updated
Feb 26, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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