NCT04596215

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 31, 2019

Completed
1.4 years until next milestone

First Posted

Study publicly available on registry

October 22, 2020

Completed
1 month until next milestone

Study Start

First participant enrolled

December 1, 2020

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2021

Completed
Last Updated

February 15, 2022

Status Verified

February 1, 2022

Enrollment Period

6 months

First QC Date

May 31, 2019

Last Update Submit

February 13, 2022

Conditions

Preoxygenation

Keywords

AnaesthesiaPreoxygenationblood gas analysisOxygen Reserve IndexDecarboxylation

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Patient characteristics

    48 hours

  • MAP

    preoxygenation of 3 minutes

  • NIRS (Near-infrared spectroscopy)

    preoxygenation of 3 minutes

  • PI

    preoxygenation of 3 minutes

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult awake patients for elective surgery with indication for an invasive arterial blood pressure measurement

You may qualify if:

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

You may not qualify if:

  • Emergency surgery
  • Patients with expected difficult airway and indication for an awake fiberoptic intubation and therefore no need of preoxygenation
  • no written informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johannes Gutenberg - Universität

Mainz, Rhineland-Palatinate, 55131, Germany

Location

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 31, 2019

First Posted

October 22, 2020

Study Start

December 1, 2020

Primary Completion

June 1, 2021

Study Completion

July 1, 2021

Last Updated

February 15, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)