Comparison of INVOS and FORE SIGHT Cerebral Oximeter

NCT ID: NCT01275898

Last Updated: 2011-08-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

35 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-04-30

Brief Summary

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Cerebral oxygenation can be monitored using near infrared spectroscopy. Different devices are available to assess cerebral oxygenation noninvasively. Beach chair position is assumed to influence cerebral oxygenation. Litte is known about the influence of prone position and head down position on cerebral oxygenation. The investigators hypothesize that these positions influence cerebral oxygenation. Further the investigators presume that the two cerebral oximeters INVOS and ForeSight provide comparable oxygenation data.

Detailed Description

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Conditions

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Changes in Cerebral Oxygenation During Different Patient Positioning Coparison of Two Cerebral Oximeters

Study Design

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Observational Model Type

COHORT

Study Groups

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Beach chair

Patients scheduled for surgical procedure in beach chair position (Shoulder surgery)

No interventions assigned to this group

Sitting position

Patients scheduled for surgical procedure in sitting position (Neurosurgery)

No interventions assigned to this group

Head down position

Patients scheduled for surgical procedure in head down position (daVinci robotic surgery)

No interventions assigned to this group

Prone position

Patients scheduled for surgical procedure in prone position

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

age \>18 and \<80 years written informed consent

Exclusion Criteria

cerebrovascular disease coronary heart disease severe organ failure hemoglobin \< 10mg/dl injury of forehead pregnancy
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Johannes Gutenberg University Mainz

OTHER

Sponsor Role lead

Locations

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Klinik für Anaesthesiologie Universitätsmedizin Mainz

Mainz, , Germany

Site Status RECRUITING

Countries

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Germany

Facility Contacts

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Closhen

Role: primary

References

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Schramm P, Tzanova I, Hagen F, Berres M, Closhen D, Pestel G, Engelhard K. Cerebral oxygen saturation and cardiac output during anaesthesia in sitting position for neurosurgical procedures: a prospective observational study. Br J Anaesth. 2016 Oct;117(4):482-488. doi: 10.1093/bja/aew250. Epub 2016 Oct 17.

Reference Type DERIVED
PMID: 28077536 (View on PubMed)

Closhen D, Engelhard K, Dette F, Werner C, Schramm P. Changes in cerebral oxygen saturation following prone positioning for orthopaedic surgery under general anaesthesia: a prospective observational study. Eur J Anaesthesiol. 2015 Jun;32(6):381-6. doi: 10.1097/EJA.0000000000000259.

Reference Type DERIVED
PMID: 25828385 (View on PubMed)

Closhen D, Treiber AH, Berres M, Sebastiani A, Werner C, Engelhard K, Schramm P. Robotic assisted prostatic surgery in the Trendelenburg position does not impair cerebral oxygenation measured using two different monitors: A clinical observational study. Eur J Anaesthesiol. 2014 Feb;31(2):104-9. doi: 10.1097/EJA.0000000000000000.

Reference Type DERIVED
PMID: 24225725 (View on PubMed)

Other Identifiers

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CLS_001

Identifier Type: -

Identifier Source: org_study_id

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