HyperoxemiaICUNCT07549763
Hyperoxemia in the Intensive Care Unit(ICU)
An observational study of Hyperoxemia and Intensive Care Unit (ICU), run by Trakya University at 1 site in Turkey (Türkiye).
Trial summary
In our study, to research the prevalence of hyperoxemia in adult patients treated in the intensive care unit (ICU) and its relationship with clinical outcomes. This single-center, observational study included 260 consecutive patients aged 18-85 years who received oxygen therapy in the ICU for respiratory failure. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Hyperoxemia, Intensive Care Unit (ICU), CPAP
- How many people
- 260 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2021to 31 Dec 2023
- 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 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study included 260 patients aged 18-85 years who received non-invasive or invasive oxygen therapy for respiratory failure as indicated in the Surgical, Reanimation and Postoperative intensive care units of Trakya University Faculty of Medicine Hospital and who were found to have hyperoxia within the first 24 hours of treatment.
Who may be able to join
- Patients between the ages of 18-85
- Patients in the intensive care unit receiving non-invasive or invasive oxygen therapy due to respiratory failure
- Patients who develop hyperoxia within the first 24 hours of treatment
Who cannot join
- Patients who stayed in the intensive care unit for less than 24 hours
- Patients suspected of brain death
- Patients suspected of being pregnant
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Trakya Üniversitesi Tip Fakültesi
Edirne, Merkez, 22100
About this study
Official title: Investigation of the Outcomes of Hyperoxemia in Patients Treated in the Intensive Care Unit
In our study, to research the prevalence of hyperoxemia in adult patients treated in the intensive care unit (ICU) and its relationship with clinical outcomes. This single-center, observational study included 260 consecutive patients aged 18-85 years who received oxygen therapy in the ICU for respiratory failure. Hyperoxia was defined as SpO₂>96% and PaO₂>100 mmHg in the first 24 hours. Patients were divided into normoxic and hyperoxic groups, and demographic characteristics, comorbidities, ICU admission scores, mechanical ventilation requirements, ICU and hospital length of stay, and in-hospital mortality were compared.The mean age of the patients was 69.9±15.4 years, and 55.8% were male. According to SpO₂-PaO₂ criteria, hyperoxia was detected in 59.6% (n=155) of patients and normoxia in 40.4% (n=105). The groups were similar in terms of age, gender, BMI, and APACHE II score. The SOFA score and admission GCS were lower in the hyperoxic group, and the duration of mechanical ventilation, ICU, and hospital stays were significantly longer (p<0.01 for all). In-hospital mortality was significantly higher in the hyperoxic group (82.5% vs. 50.4%; p<0.001).
In our study, hyperoxia developed in approximately two-thirds of the patients in the ICU, and hyperoxia was associated with increased mortality and length of stay. These results highlight the importance of avoiding hyperoxia when titrating oxygen therapy in critically ill patients.
Read the detailed description
In this study; It was aimed to examine the effects of non-invasive and invasive oxygen therapy on hyperoxemia in patients treated in the intensive care unit of Trakya University Hospital.Patients aged 18-85, who received non-invasive or invasive oxygen therapy as indicated due to respiratory failure and who were detected to have hyperoxia in the first 24 hours of treatment, were included in the study. SpO2 > 96% and PaO2 > 100 were considered hyperoxia. HFNO, CPAP and simple face mask oxygen therapy methods were used as noninvasive respiratory support methods. Patients who stayed in the intensive care unit for less than 24 hours, patients with suspected brain death, and patients with suspected pregnancy were excluded from the study. The patients' respiratory failure was treated as indicated. All patients were evaluated according to their age, gender, whether they were intubated during the ICU stay, mechanical ventilation duration if intubated, on which day they were extubated, duration of ICU stay, highest PaO2 values in the first 24 hours of ICU stay, hourly oxygen saturation levels and mortality rates. recorded from the patient file. The findings were compared with each other and it was aimed to determine which treatment methods caused more hyperoxia. In the study, it was found that 40.4% of all patients were normoxic, 59.6% were hyperoxic, 42.5% of those receiving oxygen mask therapy, 60% of those receiving HFNO therapy, 63.4% of those receiving CPAP therapy and It was found that 63.2% of those receiving IMV treatment were in the hyperoxic group. When the transition from respiratory therapy to IMV is examined; While the rate of switching from oxygen mask therapy to IMV was found to be similar in both groups, the rate of switching from HFNO and CPAP treatments to IMV was found to be statistically significantly higher in the Hyperoxia group than in the Normoxative group. In conclusion; The fact that hyperoxemia has both positive and negative aspects both in the literature and in our study necessitates the need for studies on this subject to be carried out in isolation and with a higher number of cases. Such studies will enable better evaluation of hyperoxemia in the future.
- Keywords
- hyperoxemia, intensive care unit
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| hyperoxemia group | SpO2 > %96 , PaO2>100 mmHg | |
| normoxemia group | SpO2:% 92-96 , PaO2: 60-100 mmHg |
What is being measured
The primary outcome is the main question the study is designed to answer.
In which treatment methods is more hyperoxia observed
The incidence of hyperoxemia was compared in oxygen support therapies such as simple face masks, HFNO, and CPAP.
Measured: through study completion, an average of 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2026
- Study start1 Jun 2021
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperoxemiaStudies 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 260 participants (actual)
Sponsor and investigators
- Lead sponsor
- Trakya University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gökhan Günbay, Trakya University
- Investigators
- MEHMET TURAN İNAL, Study chair, Trakya University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07549763
- Sponsor's protocol ID
- TÜTF-BAEK 2021/174
- Acronym
- ICU
- Status last verified
- Apr 2026
- First submitted
- 13 Apr 2026
- Last updated
- 24 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Outcomes of Hyperoxemia in Patients Treated in the Intensive Care Unit
- ClinicalTrials.gov ID
- NCT07549763
- Acronym / sponsor ID
- ICU / TÜTF-BAEK 2021/174
- Keywords
- hyperoxemia, intensive care unit
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 260 participants (actual)
- Lead sponsor
- Trakya UniversityUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 24 Apr 2026 (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.
In our study, to research the prevalence of hyperoxemia in adult patients treated in the intensive care unit (ICU) and its relationship with clinical outcomes. This single-center, observational study included 260 consecutive patients aged 18-85 years who received oxygen therapy in the ICU for respiratory failure. Hyperoxia was defined as SpO₂>96% and PaO₂>100 mmHg in the first 24 hours. Patients were divided into normoxic and hyperoxic groups, and demographic characteristics, comorbidities, ICU admission scores, mechanical ventilation requirements, ICU and hospital length of stay, and in-hospital mortality were compared.The mean age of the patients was 69.9±15.4 years, and 55.8% were male. According to SpO₂-PaO₂ criteria, hyperoxia was detected in 59.6% (n=155) of patients and normoxia in 40.4% (n=105). The groups were similar in terms of age, gender, BMI, and APACHE II score. The SOFA score and admission GCS were lower in the hyperoxic group, and the duration of mechanical ventilation, ICU, and hospital stays were significantly longer (p<0.01 for all). In-hospital mortality was significantly higher in the hyperoxic group (82.5% vs. 50.4%; p<0.001).
In our study, hyperoxia developed in approximately two-thirds of the patients in the ICU, and hyperoxia was associated with increased mortality and length of stay. These results highlight the importance of avoiding hyperoxia when titrating oxygen therapy in critically ill patients.
Detailed description
In this study; It was aimed to examine the effects of non-invasive and invasive oxygen therapy on hyperoxemia in patients treated in the intensive care unit of Trakya University Hospital.Patients aged 18-85, who received non-invasive or invasive oxygen therapy as indicated due to respiratory failure and who were detected to have hyperoxia in the first 24 hours of treatment, were included in the study. SpO2 > 96% and PaO2 > 100 were considered hyperoxia. HFNO, CPAP and simple face mask oxygen therapy methods were used as noninvasive respiratory support methods. Patients who stayed in the intensive care unit for less than 24 hours, patients with suspected brain death, and patients with suspected pregnancy were excluded from the study. The patients' respiratory failure was treated as indicated. All patients were evaluated according to their age, gender, whether they were intubated during the ICU stay, mechanical ventilation duration if intubated, on which day they were extubated, duration of ICU stay, highest PaO2 values in the first 24 hours of ICU stay, hourly oxygen saturation levels and mortality rates. recorded from the patient file. The findings were compared with each other and it was aimed to determine which treatment methods caused more hyperoxia. In the study, it was found that 40.4% of all patients were normoxic, 59.6% were hyperoxic, 42.5% of those receiving oxygen mask therapy, 60% of those receiving HFNO therapy, 63.4% of those receiving CPAP therapy and It was found that 63.2% of those receiving IMV treatment were in the hyperoxic group. When the transition from respiratory therapy to IMV is examined; While the rate of switching from oxygen mask therapy to IMV was found to be similar in both groups, the rate of switching from HFNO and CPAP treatments to IMV was found to be statistically significantly higher in the Hyperoxia group than in the Normoxative group. In conclusion; The fact that hyperoxemia has both positive and negative aspects both in the literature and in our study necessitates the need for studies on this subject to be carried out in isolation and with a higher number of cases. Such studies will enable better evaluation of hyperoxemia in the future.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| hyperoxemia group | – | –SpO2 > %96 , PaO2>100 mmHg |
| normoxemia group | – | –SpO2:% 92-96 , PaO2: 60-100 mmHg |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study included 260 patients aged 18-85 years who received non-invasive or invasive oxygen therapy for respiratory failure as indicated in the Surgical, Reanimation and Postoperative intensive care units of Trakya University Faculty of Medicine Hospital and who were found to have hyperoxia within the first 24 hours of treatment.
Key inclusion criteria (3 listed)
- Patients between the ages of 18-85
- Patients in the intensive care unit receiving non-invasive or invasive oxygen therapy due to respiratory failure
- Patients who develop hyperoxia within the first 24 hours of treatment
Key exclusion criteria (3 listed)
- Patients who stayed in the intensive care unit for less than 24 hours
- Patients suspected of brain death
- Patients suspected of being pregnant
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
In which treatment methods is more hyperoxia observed
Time frame: through study completion, an average of 2 year
The incidence of hyperoxemia was compared in oxygen support therapies such as simple face masks, HFNO, and CPAP.
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 24 Apr 2026.
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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.
MEHMET TURAN İNAL study chair
Trakya University
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 Hyperoxemia and Intensive Care Unit (ICU), run by Trakya University 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 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 24 Apr 2026. 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?
In which treatment methods is more hyperoxia observed (time frame: through study completion, an average of 2 year). 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 24 Apr 2026.