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PRIORI: Benefit of the Oxygen Reserve Index for Control of Success of Preoxygenation in Adults

Sponsor
Johannes Gutenberg University Mainz (Other)
Overall Status
Completed
CT.gov ID
NCT04596215
Collaborator
(none)
60
Enrollment
1
Location
7
Actual Duration (Months)
8.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Valuation of the probability for a correct detection of paO2 < 100 mmHg and paO2 > 200 mmHg using the Oxygen Reserve Index

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    As mentioned above

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    60 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official Title:
    Benefit of the Oxygen Reserve Index for Control of Success of Preoxygenation in Adults
    Actual Study Start Date :
    Dec 1, 2020
    Actual Primary Completion Date :
    Jun 1, 2021
    Actual Study Completion Date :
    Jul 1, 2021

    Outcome Measures

    Primary Outcome Measures

    1. Validation of the probability for a correct detection of paO2 < 100 mmHg and paO2 > 200 mmHg using the Oxygen Reserve Index [preoxygenation of 3 minutes]

      As mentioned above

    Secondary Outcome Measures

    1. Patient characteristics [48 hours]

      age, sex, weight, pre-existing conditions

    2. MAP [preoxygenation of 3 minutes]

      mean arterial pressure

    3. NIRS (Near-infrared spectroscopy) [preoxygenation of 3 minutes]

      cerebral O2 saturation in %, rSO2C

    4. PI [preoxygenation of 3 minutes]

      perfusion index

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Inclusion Criteria:

    • Indication of an elective surgery with invasive arterial blood pressure measurement in awake patients

    • written informed consent

    Exclusion Criteria:

    • Emergency surgery

    • Patients with expected difficult airway and indication for an awake fiberoptic intubation and therefore no need of preoxygenation

    • no written informed consent

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Johannes Gutenberg - Universität Mainz Rhineland Palatinate Germany 55131

    Sponsors and Collaborators

    • Johannes Gutenberg University Mainz

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Nina Pirlich, Dr. med., Principal Investigator, Johannes Gutenberg University Mainz
    ClinicalTrials.gov Identifier:
    NCT04596215
    Other Study ID Numbers:
    • PRIORI 1.0
    First Posted:
    Oct 22, 2020
    Last Update Posted:
    Feb 15, 2022
    Last Verified:
    Feb 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Nina Pirlich, Dr. med., Principal Investigator, Johannes Gutenberg University Mainz
    Anaesthesia
    Preoxygenation
    blood gas analysis
    Oxygen Reserve Index
    Decarboxylation

    Study Results

    No Results Posted as of Feb 15, 2022