- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07549763
Hyperoxemia in the Intensive Care Unit(ICU) (ICU)
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.
Study Overview
Status
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Merkez
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Edirne, Merkez, Turkey (Türkiye), 22100
- Trakya Universitesi Tip Fakultesi
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Patients who stayed in the intensive care unit for less than 24 hours
- Patients suspected of brain death
- Patients suspected of being pregnant
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
|
hyperoxemia group
SpO2 > %96 , PaO2>100 mmHg
|
|
normoxemia group
SpO2:% 92-96 , PaO2: 60-100 mmHg
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
through study completion, an average of 2 year
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: MEHMET TURAN İNAL, Trakya University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- TÜTF-BAEK 2021/174
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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