PreoxygenationPRIORINCT04596215
Benefit of the Oxygen Reserve Index for Control of Success of Preoxygenation in Adults
An observational study of Preoxygenation, run by Johannes Gutenberg University Mainz at 1 site in Germany.
Trial summary
Valuation of the probability for a correct detection of paO2 < 100 mmHg and paO2 > 200 mmHg using the Oxygen Reserve Index Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Preoxygenation
- How many people
- 60 participants
- Where
- 1 siteGermany
- Study dates
- 1 Dec 2020to 1 Jul 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Adult awake patients for elective surgery with indication for an invasive arterial blood pressure measurement
Who may be able to join
- Indication of an elective surgery with invasive arterial blood pressure measurement in awake patients
- written informed consent
Who cannot join
- Emergency surgery
- Patients with expected difficult airway and indication for an awake fiberoptic intubation and therefore no need of preoxygenation
- no written informed consent
Trial locations and contacts
1 site in 1 country.
Germany1 site
Johannes Gutenberg - Universität
Mainz, Rhineland-Palatinate, 55131
About this study
Valuation of the probability for a correct detection of paO2 < 100 mmHg and paO2 > 200 mmHg using the Oxygen Reserve Index
Read the detailed description
As mentioned above
- Conditions
- Preoxygenation
- Keywords
- Anaesthesia, Preoxygenation, blood gas analysis, Oxygen Reserve Index, Decarboxylation
What is being measured
The primary outcome is the main question the study is designed to answer.
Validation of the probability for a correct detection of paO2 < 100 mmHg and paO2 > 200 mmHg using the Oxygen Reserve Index
As mentioned above
Measured: preoxygenation of 3 minutes
Secondary outcomes (4)
Patient characteristics
age, sex, weight, pre-existing conditions
Measured: 48 hours
MAP
mean arterial pressure
Measured: preoxygenation of 3 minutes
NIRS (Near-infrared spectroscopy)
cerebral O2 saturation in %, rSO2C
Measured: preoxygenation of 3 minutes
PI
perfusion index
Measured: preoxygenation of 3 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2020
- Study start1 Dec 2020
- Primary completion1 Jun 2021
- Study completion1 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PreoxygenationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johannes Gutenberg University Mainz
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nina Pirlich, Dr. med., Johannes Gutenberg University Mainz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04596215
- Sponsor's protocol ID
- PRIORI 1.0
- Acronym
- PRIORI
- Status last verified
- Feb 2022
- First submitted
- 31 May 2019
- Last updated
- 15 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Benefit of the Oxygen Reserve Index for Control of Success of Preoxygenation in Adults
- ClinicalTrials.gov ID
- NCT04596215
- Acronym / sponsor ID
- PRIORI / PRIORI 1.0
- Conditions
- Preoxygenation
- Keywords
- Anaesthesia, Preoxygenation, blood gas analysis, Oxygen Reserve Index, Decarboxylation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Johannes Gutenberg University MainzUniversity, hospital or other
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 1 Jun 2021 (actual)
- Study completion
- 1 Jul 2021 (actual)
- First posted
- 22 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Valuation of the probability for a correct detection of paO2 < 100 mmHg and paO2 > 200 mmHg using the Oxygen Reserve Index
Detailed description
As mentioned above
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Adult awake patients for elective surgery with indication for an invasive arterial blood pressure measurement
Key inclusion criteria (2 listed)
- Indication of an elective surgery with invasive arterial blood pressure measurement in awake patients
- written informed consent
Key exclusion criteria (3 listed)
- Emergency surgery
- Patients with expected difficult airway and indication for an awake fiberoptic intubation and therefore no need of preoxygenation
- no written informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
4 secondary outcomes
Patient characteristics
Time frame: 48 hours
MAP
Time frame: preoxygenation of 3 minutes
NIRS (Near-infrared spectroscopy)
Time frame: preoxygenation of 3 minutes
PI
Time frame: preoxygenation of 3 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2022.
- Individual participant dataSharing planned: No
Related trials for Preoxygenation
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Patient's Experience of Receiving Preoxygenation With the TTIM (Tube Tip in Mouth) Versus the Face Mask
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Effect of Different-Flow High-Flow Nasal Cannula Versus Traditional Face Mask Oxygenation on Safe Apnea Time in Obese Patients
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Preoperative Performance Indicators, Preoxygenation and Oxygen Reserve Relationship
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Preoxygenation, run by Johannes Gutenberg University Mainz at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2022.