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

February 13, 2022 updated by: Nina Pirlich, Dr. med., Johannes Gutenberg University Mainz
Valuation of the probability for a correct detection of paO2 < 100 mmHg and paO2 > 200 mmHg using the Oxygen Reserve Index

Study Overview

Status

Completed

Conditions

Detailed Description

As mentioned above

Study Type

Observational

Enrollment (Actual)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Rhineland Palatinate
      • Mainz, Rhineland Palatinate, Germany, 55131
        • Johannes Gutenberg - Universität

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders 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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
preoxygenation of 3 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient characteristics
Time Frame: 48 hours
age, sex, weight, pre-existing conditions
48 hours
MAP
Time Frame: preoxygenation of 3 minutes
mean arterial pressure
preoxygenation of 3 minutes
NIRS (Near-infrared spectroscopy)
Time Frame: preoxygenation of 3 minutes
cerebral O2 saturation in %, rSO2C
preoxygenation of 3 minutes
PI
Time Frame: preoxygenation of 3 minutes
perfusion index
preoxygenation of 3 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johannes Gutenberg University Mainz

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2020

Primary Completion (Actual)

June 1, 2021

Study Completion (Actual)

July 1, 2021

Study Registration Dates

First Submitted

May 31, 2019

First Submitted That Met QC Criteria

October 16, 2020

First Posted (Actual)

October 22, 2020

Study Record Updates

Last Update Posted (Actual)

February 15, 2022

Last Update Submitted That Met QC Criteria

February 13, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • PRIORI 1.0

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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