Pressure InjuryNCT07691710
Arterial Blood Gas Levels, Oxygen Saturation, and Pressure Injury Risk in ICU Patients
An observational study of Pressure Injury and Intensive Care Unit (ICU), run by Istanbul University at 1 site in Turkey (Türkiye).
Trial summary
The purpose of this study is to examine the relationship between arterial blood gas (ABG) parameters and oxygen saturation (SpO₂) levels and the risk of pressure injury development in patients hospitalized in intensive care units, and to provide a scientific contribution to the processes for assessing pressure injury… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pressure Injury, Intensive Care Unit (ICU)
- How many people
- 122 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 26 Mar 2026to 15 Jan 2027
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Study population: Patients eligible for inclusion in the study are those aged 18 years and older who have been hospitalized in the intensive care unit for at least 72 hours, are conscious or sedated, and from whom an arterial blood gas sample can be obtained. In addition, patients themselves or their relatives must agree to participate in the study.
Who may be able to join
- Patients who have been hospitalized in the intensive care unit for at least 72 hours,
- Patients aged 18 years and older,
- Patients who are conscious or sedated and from whom an arterial blood gas sample can be obtained,
- Patients or their relatives who agree to participate in the study.
Who cannot join
- Patients with superficial skin lesions or existing pressure injuries, or a history of pressure injuries,
- Patients whose intensive care unit stay is shorter than 72 hours,
- Patients diagnosed with diabetes,
- Patients with circulatory problems.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Prof. Dr. Cemil Tascıoglu City Hospital
Istanbul, Istanbul, 34384
About this study
Official title: Investigation of the Relationship Between Arterial Blood Gas Parameters, Oxygen Saturation, and the Risk of Pressure Injury Development in Intensive Care Patients
The purpose of this study is to examine the relationship between arterial blood gas (ABG) parameters and oxygen saturation (SpO₂) levels and the risk of pressure injury development in patients hospitalized in intensive care units, and to provide a scientific contribution to the processes for assessing pressure injury risk based on the findings obtained.
Read the detailed description
Pressure injuries are defined as localized damage to the skin and/or underlying soft tissue caused by prolonged pressure and/or shear forces, and they most commonly occur over bony prominences (Han et al., 2025). In intensive care patients, these injuries lead to serious consequences such as pain, risk of infection, prolonged hospital stay, and mortality (Labeau et al., 2021). In critically ill patients, inadequate tissue perfusion and oxygenation are identified as one of the main pathophysiological mechanisms involved in the development of pressure injuries (Han et al., 2025). Hypoxia, which occurs when cells are unable to meet their metabolic needs, reduces tissue tolerance and adversely affects the healing process. While insufficient oxygen inhibits collagen synthesis and cellular regeneration, it also reduces blood flow by causing vasoconstriction (Lucchini et al., 2024). This causes tissues in areas exposed to pressure to be more easily damaged.
Therefore, monitoring oxygenation levels is critically important in predicting the risk of pressure injury development. Han et al. (2024) demonstrated that as PaO₂ levels decrease, the risk of pressure injury increases significantly, and that this relationship is supported by a nonlinear dose-response curve. On the other hand, it has been suggested that oxygen saturation may be a more reliable indicator than PaO₂, and that the risk may increase up to sixfold at low oxygen saturation levels (Rahimi-Bashar et al., 2025).
In this context, this study aims to evaluate the relationship between arterial blood gas parameters - pH, PaO₂, PaCO₂, and HCO₃- - and oxygen saturation (SpO₂) levels and the risk of pressure injury development in intensive care patients from the perspective of nursing care.
- Conditions
- Pressure Injury, Intensive Care Unit (ICU)
- Medical subject headings
- Pressure Ulcer
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 |
|---|---|---|
| Intensive Care Unit Patients | Patients admitted to the intensive care unit whose arterial blood gas parameters, including pH, PaO2, PaCO2, and HCO3-, and oxygen saturation levels will be evaluated in relation to the risk of pressure injury development. No intervention will be administered. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Risk of Pressure Injury Development
The risk of pressure injury development in intensive care unit patients will be assessed in relation to arterial blood gas parameters and oxygen saturation levels.
Measured: From intensive care unit admission until discharge from the intensive care unit or study completion, up to 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2026
- Study start26 Mar 2026
- Primary completion30 Dec 2026 (estimated)
- Study completion15 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pressure InjuryStudies of the same condition, open and under way.
- More trials run by Istanbul UniversityThe sponsor's other registered studies.
- 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
- Cross-sectional
- Enrolment
- 122 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Berna Bugan, Istanbul University
- Investigators
- Berna Bugan, Research Assistant, Principal investigator, Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07691710
- Sponsor's protocol ID
- IU-MSC-044
- Status last verified
- Jul 2026
- First submitted
- 2 Jul 2026
- Last updated
- 9 Jul 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 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Relationship Between Arterial Blood Gas Parameters, Oxygen Saturation, and the Risk of Pressure Injury Development in Intensive Care Patients
- ClinicalTrials.gov ID
- NCT07691710
- Acronym / sponsor ID
- IU-MSC-044
- Conditions
- Pressure Injury, Intensive Care Unit (ICU)
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 122 participants (estimated)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- 26 Mar 2026 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 15 Jan 2027 (estimated)
- First posted
- 9 Jul 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.
The purpose of this study is to examine the relationship between arterial blood gas (ABG) parameters and oxygen saturation (SpO₂) levels and the risk of pressure injury development in patients hospitalized in intensive care units, and to provide a scientific contribution to the processes for assessing pressure injury risk based on the findings obtained.
Detailed description
Pressure injuries are defined as localized damage to the skin and/or underlying soft tissue caused by prolonged pressure and/or shear forces, and they most commonly occur over bony prominences (Han et al., 2025). In intensive care patients, these injuries lead to serious consequences such as pain, risk of infection, prolonged hospital stay, and mortality (Labeau et al., 2021). In critically ill patients, inadequate tissue perfusion and oxygenation are identified as one of the main pathophysiological mechanisms involved in the development of pressure injuries (Han et al., 2025). Hypoxia, which occurs when cells are unable to meet their metabolic needs, reduces tissue tolerance and adversely affects the healing process. While insufficient oxygen inhibits collagen synthesis and cellular regeneration, it also reduces blood flow by causing vasoconstriction (Lucchini et al., 2024). This causes tissues in areas exposed to pressure to be more easily damaged.
Therefore, monitoring oxygenation levels is critically important in predicting the risk of pressure injury development. Han et al. (2024) demonstrated that as PaO₂ levels decrease, the risk of pressure injury increases significantly, and that this relationship is supported by a nonlinear dose-response curve. On the other hand, it has been suggested that oxygen saturation may be a more reliable indicator than PaO₂, and that the risk may increase up to sixfold at low oxygen saturation levels (Rahimi-Bashar et al., 2025).
In this context, this study aims to evaluate the relationship between arterial blood gas parameters - pH, PaO₂, PaCO₂, and HCO₃- - and oxygen saturation (SpO₂) levels and the risk of pressure injury development in intensive care patients from the perspective of nursing care.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intensive Care Unit Patients | – | –Patients admitted to the intensive care unit whose arterial blood gas parameters, including pH, PaO2, PaCO2, and HCO3-, and oxygen saturation levels will be evaluated in relation to the risk of pressure injury development. No intervention will be administered. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients eligible for inclusion in the study are those aged 18 years and older who have been hospitalized in the intensive care unit for at least 72 hours, are conscious or sedated, and from whom an arterial blood gas sample can be obtained. In addition, patients themselves or their relatives must agree to participate in the study.
Key inclusion criteria (4 listed)
- Patients who have been hospitalized in the intensive care unit for at least 72 hours,
- Patients aged 18 years and older,
- Patients who are conscious or sedated and from whom an arterial blood gas sample can be obtained,
- Patients or their relatives who agree to participate in the study.
Key exclusion criteria (4 listed)
- Patients with superficial skin lesions or existing pressure injuries, or a history of pressure injuries,
- Patients whose intensive care unit stay is shorter than 72 hours,
- Patients diagnosed with diabetes,
- Patients with circulatory problems.
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
Risk of Pressure Injury Development
Time frame: From intensive care unit admission until discharge from the intensive care unit or study completion, up to 12 months.
The risk of pressure injury development in intensive care unit patients will be assessed in relation to arterial blood gas parameters and oxygen saturation levels.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 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.
Berna Bugan, Research Assistant principal investigator
Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
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 Pressure Injury and Intensive Care Unit (ICU), run by Istanbul 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 4 inclusion and 4 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: enrolling by invitation, as of the sponsor's last update on 9 Jul 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?
This study is still under way. Results are not available in the source record yet.
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?
Risk of Pressure Injury Development (time frame: From intensive care unit admission until discharge from the intensive care unit or study completion, up to 12 months.). 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 9 Jul 2026.