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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04596215
Recruitment Status : Completed
First Posted : October 22, 2020
Last Update Posted : February 15, 2022
Sponsor:
Information provided by (Responsible Party):
Nina Pirlich, Dr. med., Johannes Gutenberg University Mainz

Study Description
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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
Preoxygenation

Detailed Description:
As mentioned above
Study Design
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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 : December 1, 2020
Actual Primary Completion Date : June 1, 2021
Actual Study Completion Date : July 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Oxygen Therapy

Groups and Cohorts
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Outcome Measures
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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 [ Time Frame: preoxygenation of 3 minutes ]
    As mentioned above


Secondary Outcome Measures :
  1. Patient characteristics [ Time Frame: 48 hours ]
    age, sex, weight, pre-existing conditions

  2. MAP [ Time Frame: preoxygenation of 3 minutes ]
    mean arterial pressure

  3. NIRS (Near-infrared spectroscopy) [ Time Frame: preoxygenation of 3 minutes ]
    cerebral O2 saturation in %, rSO2C

  4. PI [ Time Frame: preoxygenation of 3 minutes ]
    perfusion index


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Adult awake patients for elective surgery with indication for an invasive arterial blood pressure measurement
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04596215


Locations
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Germany
Johannes Gutenberg - Universität
Mainz, Rhineland Palatinate, Germany, 55131
Sponsors and Collaborators
Johannes Gutenberg University Mainz
More Information
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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: October 22, 2020    Key Record Dates
Last Update Posted: February 15, 2022
Last Verified: February 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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., Johannes Gutenberg University Mainz:
Anaesthesia
Preoxygenation
blood gas analysis
Oxygen Reserve Index
Decarboxylation