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NCT05807815
The Effectiveness of the Use of Oxygen Reserve Index in Preventing Hyperoxia in the Intensive Care Unit.
NA trial testing Titration of fraction of inspired oxygen (FiO2) guided by ORI and oxygen saturation in Hyperoxia in 60 participants. Completed in 13 March 2023.
1 March 2023
Quick facts
| Lead sponsor | Tepecik Training and Research Hospital |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | prevention |
| Enrollment | 60 |
| Start date | 1 March 2021 |
| Primary completion | 1 March 2023 |
| Estimated completion | 13 March 2023 |
| Sites | 1 location across Turkey (Türkiye) |
Drugs / interventions tested
- Titration of fraction of inspired oxygen (FiO2) guided by ORI and oxygen saturation
Conditions studied
- Hyperoxia — all drugs for Hyperoxia →
- Complication — all drugs for Complication →
- Mechanical Ventilation Complication — all drugs for Mechanical Ventilation Complication →
Sponsor
Tepecik Training and Research Hospital
Who can join
Adults 18 to 85, any sex, with Hyperoxia or Complication. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Effectiveness of the oxygen reserve index in detecting and preventing hyperoxia in critically ill patients on mechanical ventilation: a randomized controlled trial.
Sarıtaş A, Sarıtaş PU, Uzun U. · · 2023 · cited 1× · PMID 38168521
Verify or expand the search:
- PubMed search for NCT05807815
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Titration of fraction of inspired oxygen (FiO2) guided by ORI and oxygen saturation
Trials testing the same drug.
- NCT05770583 — The Effectiveness of FiO2 Titration Guided by the Oxygen Reserve Index in Preventing Hyperoxia. · NA · completed
Other recruiting trials for Hyperoxia
Currently open trials in the same condition.
- NCT05412810 — Oxidative Lipidomic Biomarkers During Mechanical Ventilation in Critically Ill Patients (OXY-BAL). · recruiting
- NCT04413097 — Delayed Cord Clamping With Oxygen In Extremely Low Gestation Infants · NA · active not recruiting
Other Tepecik Training and Research Hospital trials
Trials by the same sponsor.
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- NCT06563830 — Prevent Medical Device-Related Pressure Injury · NA · not yet recruiting
- NCT05946291 — Simulation Applications on the Level of Pressure Injury Knowledge and Evaluation · NA · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05807815 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Tepecik Training and Research Hospital
- Last refreshed: 11 April 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05807815.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing