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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02071550
Acronym
NIRS AND PEEP
Enrollment
44
Registered
2014-02-26
Start date
2013-08-31
Completion date
Unknown
Last updated
2014-02-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Laparoscopic Cholecystectomy

Keywords

laparoscopic cholecystectomy, near infrared spectroscopy, positive end expiratory pressure

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.

Interventions

DEVICEFORESİGHT cerebral oxygen monitor and INVOS cerebral oxygen monitor
DEVICEFORESIGHT and INVOS monitor

Sponsors

Turkiye Yuksek Ihtisas Education and Research Hospital
Lead SponsorOTHER_GOV

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
change in cerebral oxymetry during laparoscopy1 day

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 17, 2026