NCT07549763

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
260

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2021

Typical duration 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2021

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

April 13, 2026

Completed
11 days until next milestone

First Posted

Study publicly available on registry

April 24, 2026

Completed
Last Updated

April 24, 2026

Status Verified

April 1, 2026

Enrollment Period

2.6 years

First QC Date

April 13, 2026

Last Update Submit

April 18, 2026

Conditions

Keywords

hyperoxemiaintensive care unit

Outcome Measures

Primary Outcomes (1)

  • 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.

    through study completion, an average of 2 year

Study Arms (2)

hyperoxemia group

SpO2 \> %96 , PaO2\>100 mmHg

normoxemia group

SpO2:% 92-96 , PaO2: 60-100 mmHg

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
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.

You may qualify if:

  • 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

You may not qualify if:

  • Patients who stayed in the intensive care unit for less than 24 hours
  • Patients suspected of brain death
  • Patients suspected of being pregnant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Trakya Üniversitesi Tip Fakültesi

Edirne, Merkez, 22100, Turkey (Türkiye)

Location

Study Officials

  • MEHMET TURAN İNAL

    Trakya University

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
RESEARCH ASSISTANT DOCTOR

Study Record Dates

First Submitted

April 13, 2026

First Posted

April 24, 2026

Study Start

June 1, 2021

Primary Completion

December 31, 2023

Study Completion

December 31, 2023

Last Updated

April 24, 2026

Record last verified: 2026-04

Locations