Benefit of the Oxygen Reserve Index for Control of Success NCT04596215

Updated 06/21/2024

Clinical Trial Details — Status: Completed

Administrative data
NCT number	NCT04596215
Other study ID #	PRIORI 1.0
Secondary ID
Status	Completed
Phase
First received
Last updated
Start date	December 1, 2020
Est. completion date	July 1, 2021

Study information
Verified date	February 2022
Source	Johannes Gutenberg University Mainz
Contact	n/a
Is FDA regulated	No
Health authority
Study type	Observational

Clinical Trial Summary

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

Description:

As mentioned above

Recruitment information / eligibility
Status	Completed
Enrollment	60
Est. completion date	July 1, 2021
Est. primary completion date	June 1, 2021
Accepts healthy volunteers
Gender	All
Age group	18 Years and older
Eligibility	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 Design

Related Conditions & MeSH terms

Preoxygenation

Locations
Country	Name	City	State
Germany	Johannes Gutenberg - Universität	Mainz	Rhineland Palatinate

Sponsors *(1)*
Lead Sponsor	Collaborator
Johannes Gutenberg University Mainz

Country where clinical trial is conducted

Germany,

Outcome
Type	Measure	Description	Time frame	Safety issue
Primary	Validation of the probability for a correct detection of paO2 < 100 mmHg and paO2 > 200 mmHg using the Oxygen Reserve Index	As mentioned above	preoxygenation of 3 minutes
Secondary	Patient characteristics	age, sex, weight, pre-existing conditions	48 hours
Secondary	MAP	mean arterial pressure	preoxygenation of 3 minutes
Secondary	NIRS (Near-infrared spectroscopy)	cerebral O2 saturation in %, rSO2C	preoxygenation of 3 minutes
Secondary	PI	perfusion index	preoxygenation of 3 minutes

See also
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