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NCT03156218
The Effect of FiO2 on PaO2/FiO2 Ratio
NA trial testing Modulation of FiO2 in PaO2/FiO2 Ratio in 20 participants. Status unknown.
1 January 2020
Quick facts
| Lead sponsor | Amsterdam UMC, location VUmc |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | diagnostic |
| Enrollment | 20 |
| Start date | 1 September 2017 |
| Primary completion | 1 January 2020 |
| Estimated completion | 1 August 2020 |
| Sites | 1 location across Netherlands |
Drugs / interventions tested
- Modulation of FiO2 — full drug profile →
Conditions studied
- PaO2/FiO2 Ratio — all drugs for PaO2/FiO2 Ratio →
Sponsor
Amsterdam UMC, location VUmc — full company profile →
Who can join
18 and older, any sex, with PaO2/FiO2 Ratio. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The PaO2/FiO2 ratio is frequently used to determine the severity of lung injury in mechanically ventilated patients. However, several mathematical models have shown that PaO2/FiO2 ratio depends on FiO2. The relationship is complex and depends on numerous physiological variables, including shunt fraction, and arterio-venous oxygen difference. The nonlinear relation between PaO2/FiO2 and FiO2 underlines the limitations describing the intensity of hypoxemia using PaO2/FiO2 and is thus of major importance for the clinician. Surprisingly, this relationship has only been assessed mathematically. Obviously, the accuracy of the mathematical relationship depends on the input variables used. The current study is designed to assess the PaO2/FiO2 vs FiO2 relation in mechanically ventilated patients without ARDS (n =10) and with mild or moderate ARDS (n =10). In order to explain the dependency of the PaO2/FiO2 on FiO2, shunt fraction and alveolar - arterial oxygen difference ((A-a)DO2) will be determined in these patients.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT03156218
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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 NCT03156218 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Amsterdam UMC, location VUmc
- Last refreshed: 26 April 2019
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/NCT03156218.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing