HyperoxiaNCT05807815
The Effectiveness of the Use of Oxygen Reserve Index in Preventing Hyperoxia in the Intensive Care Unit.
A study testing Titration of fraction of inspired oxygen (FiO2) guided by ORI and oxygen saturation in people with Hyperoxia and Complication, run by Tepecik Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Oxygen therapy is the most common treatment modality for patients with hypoxemia in intensive care units, but target values for normoxemia are not clearly defined. Therefore, iatrogenic hyperoxemia is a very common situation. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Hyperoxia, Complication, Mechanical Ventilation Complication
- What is being tested?
- Titration of fraction of inspired oxygen (FiO2) guided by ORI and oxygen saturation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2021to 13 Mar 2023
- Phase
- Interventional
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients older than 18 years,
- Patients whose oxygen saturation >97%
- Patients that have invasive arterial monitorization
Who cannot join
- Patients younger than 18
- Patients that need to be treated with high doses of vasopressors,
- Patients having peripheric hypoperfusion,
- Hemodynamically unstable patients,
- Patients with hemoglobinopathy,
- Pregnancy,
Show all 9Show fewer
- Morbid obesity (bmi>40 kg/m2),
- Patients with arrythmia that can result in hemodynamic instability, patients with acute coronary syndrome
- Acute respiratory failure or ARDS.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Tepecik Research and Training Hospital
Izmir, Konak, 35110
About this study
Official title: Determination of the Incidence of Hyperoxia and the Effectiveness of FiO2 Titration Guided by the Oxygen Reserve Index in Preventing Hyperoxia in Mechanically Ventilated Patients in the Intensive Care Unit.
Oxygen therapy is the most common treatment modality for patients with hypoxemia in intensive care units, but target values for normoxemia are not clearly defined. Therefore, iatrogenic hyperoxemia is a very common situation. In intensive care units, FiO2 is usually adjusted according to hypoxia and hyperoxia is ignored in patients under mechanical ventilator support. Even though there are many side effects reported related to hyperoxemia and hyperoxemia is shown to be related to worse outcome than expected; clinicians still observe hyperoxemia frequently.
Continuous ORi monitoring can be used for detecting and preventing hyperoxia. The ability to perform FiO2 titration with ORi may be an appropriate monitoring management to prevent the harmful effects of hyperoxia. In this study, it was aimed to investigate the effectiveness of ORi-guided FiO2 titration in preventing hyperoxia in patients undergoing mechanical ventilation in the intensive care unit and to determine the incidence of hyperoxia.
Read the detailed description
In intensive care units, FiO2 is usually adjusted according to hypoxia and hyperoxia is ignored in patients under mechanical ventilator support. Even though there are many side effects reported related to hyperoxemia and hyperoxemia is shown to be related to worse outcome than expected; clinicians still observe hyperoxemia frequently.
Oxygen reserve index (ORi™) (Masimo Corp., Irvine, USA) can guide clinicians in detection of hyperoxia. ORi is a parameter which can evaluate partial pressure of oxygen (PaO2) rating from 0 to 1. There are growing evidences in ORi that it might be helpful to reduce hyperoxia in general anesthesia. Continuous ORi monitoring can be used for detecting and preventing hyperoxia. The ability to perform FiO2 titration with ORi may be an appropriate monitoring management to prevent the harmful effects of hyperoxia.
In this study, it was aimed to investigate the effectiveness of ORi-guided FiO2 titration in preventing hyperoxia in patients undergoing mechanical ventilation in the intensive care unit and to determine the incidence of hyperoxia.
- Conditions
- Hyperoxia, Complication, Mechanical Ventilation Complication
- Being tested
- Titration of fraction of inspired oxygen (FiO2) guided by ORI and oxygen saturation
- Keywords
- Hyperoxia, Fraction of inspired oxygen, Intensive care unit
- Medical subject headings
- Hyperoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Titration of fraction of inspired oxygen (FiO2) guided by ORI and oxygen saturationProcedure or surgery
FiO2 will be titrated by reducing 10% if Ori>0.01 and oxygen saturation ≥ 98% until Ori is 0.00.
FiO2 will not be changed if Ori is 0.00 and %95<oxygen saturation≤%98 FiO2 will be increased by 10% if oxygen saturation <95 or PaO2<60 mmHg
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | Patients with oxygen saturation > 97% will only be observed. ORi values will be recorded blindly from the clinician. Adjustments to be made in FiO2 will be determined by the intensive care doctor independently of the study, and only observation will be made in this group. |
| ORi+SpO2 (oxygen saturation) group | Active comparator | Fraction of inspired oxygen (FiO2) is titrated guided by oxygen saturation in that range; %95<oxygen saturation≤%98 Receives: Procedure: Titration of fraction of inspired oxygen (FiO2) guided by ORI and oxygen saturation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation of FiO2 and ORi value
Correlation of FiO2 value and ORi value. FiO2 adjusted until ORi reaches to zero and %95<oxygen saturation≤%98
Measured: Up to 24 weeks
Secondary outcomes (4)
Fraction of inspired oxygen (FiO2)
Fraction of inspired oxygen (FiO2) in every 4 hour intervals
Measured: Up to 48 hours
Mean arterial blood pressure (MAP)
Measurement of mean arteria blood pressure (SBP)
Measured: Up to 48 hours
Heart rate (HR)
Measurement of heart rate (HR)
Measured: Up to 48 hours
Positive end-expiratory pressure (PEEP)
Measurement of PEEP
Measured: Up to 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2023
- Study start1 Mar 2021
- Primary completion1 Mar 2023
- Study completion13 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for HyperoxiaStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tepecik Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aykut Saritas, Tepecik Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05807815
- Sponsor's protocol ID
- Health Sciences University
- Status last verified
- Mar 2023
- First submitted
- 15 Mar 2023
- Last updated
- 11 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
de Graaff AE, Dongelmans DA, Binnekade JM, de Jonge E. Clinicians' response to hyperoxia in ventilated patients in a Dutch ICU depends on the level of FiO2. Intensive Care Med. 2011 Jan;37(1):46-51. doi: 10.1007/s00134-010-2025-z. Epub 2010 Sep 28.
PubMed 20878146Rincon F, Kang J, Maltenfort M, Vibbert M, Urtecho J, Athar MK, Jallo J, Pineda CC, Tzeng D, McBride W, Bell R. Association between hyperoxia and mortality after stroke: a multicenter cohort study. Crit Care Med. 2014 Feb;42(2):387-96. doi: 10.1097/CCM.0b013e3182a27732.
PubMed 24164953Mach WJ, Thimmesch AR, Pierce JT, Pierce JD. Consequences of hyperoxia and the toxicity of oxygen in the lung. Nurs Res Pract. 2011;2011:260482. doi: 10.1155/2011/260482. Epub 2011 Jun 5.
PubMed 21994818Scheeren TWL, Belda FJ, Perel A. Correction to: The oxygen reserve index (ORI): a new tool to monitor oxygen therapy. J Clin Monit Comput. 2018 Jun;32(3):579-580. doi: 10.1007/s10877-018-0104-9.
PubMed 29445905Yoshida K, Isosu T, Noji Y, Ebana H, Honda J, Sanbe N, Obara S, Murakawa M. Adjustment of oxygen reserve index (ORi) to avoid excessive hyperoxia during general anesthesia. J Clin Monit Comput. 2020 Jun;34(3):509-514. doi: 10.1007/s10877-019-00341-9. Epub 2019 Jun 22.
PubMed 31227971
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of the Incidence of Hyperoxia and the Effectiveness of FiO2 Titration Guided by the Oxygen Reserve Index in Preventing Hyperoxia in Mechanically Ventilated Patients in the Intensive Care Unit.
- ClinicalTrials.gov ID
- NCT05807815
- Acronym / sponsor ID
- Health Sciences University
- Conditions
- Hyperoxia, Complication, Mechanical Ventilation Complication
- Keywords
- Hyperoxia, Fraction of inspired oxygen, Intensive care unit
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Tepecik Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 1 Mar 2023 (actual)
- Study completion
- 13 Mar 2023 (actual)
- First posted
- 11 Apr 2023 (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.
Oxygen therapy is the most common treatment modality for patients with hypoxemia in intensive care units, but target values for normoxemia are not clearly defined. Therefore, iatrogenic hyperoxemia is a very common situation. In intensive care units, FiO2 is usually adjusted according to hypoxia and hyperoxia is ignored in patients under mechanical ventilator support. Even though there are many side effects reported related to hyperoxemia and hyperoxemia is shown to be related to worse outcome than expected; clinicians still observe hyperoxemia frequently.
Continuous ORi monitoring can be used for detecting and preventing hyperoxia. The ability to perform FiO2 titration with ORi may be an appropriate monitoring management to prevent the harmful effects of hyperoxia. In this study, it was aimed to investigate the effectiveness of ORi-guided FiO2 titration in preventing hyperoxia in patients undergoing mechanical ventilation in the intensive care unit and to determine the incidence of hyperoxia.
Detailed description
In intensive care units, FiO2 is usually adjusted according to hypoxia and hyperoxia is ignored in patients under mechanical ventilator support. Even though there are many side effects reported related to hyperoxemia and hyperoxemia is shown to be related to worse outcome than expected; clinicians still observe hyperoxemia frequently.
Oxygen reserve index (ORi™) (Masimo Corp., Irvine, USA) can guide clinicians in detection of hyperoxia. ORi is a parameter which can evaluate partial pressure of oxygen (PaO2) rating from 0 to 1. There are growing evidences in ORi that it might be helpful to reduce hyperoxia in general anesthesia. Continuous ORi monitoring can be used for detecting and preventing hyperoxia. The ability to perform FiO2 titration with ORi may be an appropriate monitoring management to prevent the harmful effects of hyperoxia.
In this study, it was aimed to investigate the effectiveness of ORi-guided FiO2 titration in preventing hyperoxia in patients undergoing mechanical ventilation in the intensive care unit and to determine the incidence of hyperoxia.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –Patients with oxygen saturation > 97% will only be observed. ORi values will be recorded blindly from the clinician. Adjustments to be made in FiO2 will be determined by the intensive care doctor independently of the study, and only observation will be made in this group. |
| ORi+SpO2 (oxygen saturation) group | Active comparator | Procedure: Titration of fraction of inspired oxygen (FiO2) guided by ORI and oxygen saturationFraction of inspired oxygen (FiO2) is titrated guided by oxygen saturation in that range; %95<oxygen saturation≤%98 |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients older than 18 years,
- Patients whose oxygen saturation >97%
- Patients that have invasive arterial monitorization
Key exclusion criteria (9 listed)
- Patients younger than 18
- Patients that need to be treated with high doses of vasopressors,
- Patients having peripheric hypoperfusion,
- Hemodynamically unstable patients,
- Patients with hemoglobinopathy,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Titration of fraction of inspired oxygen (FiO2) guided by ORI and oxygen saturationFiO2 will be titrated by reducing 10% if Ori>0.01 and oxygen saturation ≥ 98% until Ori is 0.00. FiO2 will not be changed if Ori is 0.00 and %95<oxygen saturation≤%98 FiO2 will be increased by 10% if oxygen saturation <95 or PaO2<60 mmHg | Procedure or surgery | ORi+SpO2 (oxygen saturation) group |
Primary outcome
Correlation of FiO2 and ORi value
Time frame: Up to 24 weeks
Correlation of FiO2 value and ORi value. FiO2 adjusted until ORi reaches to zero and %95<oxygen saturation≤%98
4 secondary outcomes
Fraction of inspired oxygen (FiO2)
Time frame: Up to 48 hours
Mean arterial blood pressure (MAP)
Time frame: Up to 48 hours
Heart rate (HR)
Time frame: Up to 48 hours
Positive end-expiratory pressure (PEEP)
Time frame: Up to 48 hours
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 11 Apr 2023.
- Background: PubMed 20878146de Graaff AE, Dongelmans DA, Binnekade JM, de Jonge E. Clinicians' response to hyperoxia in ventilated patients in a Dutch ICU depends on the level of FiO2. Intensive Care Med. 2011 Jan;37(1):46-51. doi: 10.1007/s00134-010-2025-z. Epub 2010 Sep 28.
- Background: PubMed 24164953Rincon F, Kang J, Maltenfort M, Vibbert M, Urtecho J, Athar MK, Jallo J, Pineda CC, Tzeng D, McBride W, Bell R. Association between hyperoxia and mortality after stroke: a multicenter cohort study. Crit Care Med. 2014 Feb;42(2):387-96. doi: 10.1097/CCM.0b013e3182a27732.
- Background: PubMed 21994818Mach WJ, Thimmesch AR, Pierce JT, Pierce JD. Consequences of hyperoxia and the toxicity of oxygen in the lung. Nurs Res Pract. 2011;2011:260482. doi: 10.1155/2011/260482. Epub 2011 Jun 5.
- Background: PubMed 29445905Scheeren TWL, Belda FJ, Perel A. Correction to: The oxygen reserve index (ORI): a new tool to monitor oxygen therapy. J Clin Monit Comput. 2018 Jun;32(3):579-580. doi: 10.1007/s10877-018-0104-9.
- Background: PubMed 31227971Yoshida K, Isosu T, Noji Y, Ebana H, Honda J, Sanbe N, Obara S, Murakawa M. Adjustment of oxygen reserve index (ORi) to avoid excessive hyperoxia during general anesthesia. J Clin Monit Comput. 2020 Jun;34(3):509-514. doi: 10.1007/s10877-019-00341-9. Epub 2019 Jun 22.
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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?
A study testing Titration of fraction of inspired oxygen (FiO2) guided by ORI and oxygen saturation in people with Hyperoxia and Complication, run by Tepecik Training and Research Hospital at 1 site in Turkey (Türkiye).
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 3 inclusion and 9 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 11 Apr 2023. 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 Turkey (Türkiye). 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?
Correlation of FiO2 and ORi value (time frame: Up to 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05807815, which also lists 5 linked publications.
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 11 Apr 2023.