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NCT05094661: RUTIROX
Predictors of Non-invasive Respiratory Support Failure in COVID-19 Pneumonia
NA trial testing BiPAP in Noninvasive Ventilation in 135 participants. Completed in 7 November 2022.
7 November 2022
Quick facts
| Lead sponsor | Germans Trias i Pujol Hospital |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 135 |
| Start date | 18 February 2021 |
| Primary completion | 7 November 2022 |
| Estimated completion | 7 November 2022 |
| Sites | 1 location across Spain |
Drugs / interventions tested
- BiPAP
- CPAP
Conditions studied
- Noninvasive Ventilation — all drugs for Noninvasive Ventilation →
- Covid19 — all drugs for Covid19 →
- Distress; Respiratory Syndrome, Adult — all drugs for Distress; Respiratory Syndrome, Adult →
Sponsor
Germans Trias i Pujol Hospital
Who can join
18 and older, any sex, with Noninvasive Ventilation or Covid19. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The main objective of the current study is to search predictors of non-invasive respiratory support failure, like high -flow oxygen system (HFO) and pressure systems, Bilevel positive airway pressure (BiPAP) and continuous positive airway pressure (CPAP), in patients with acute hypoxemia produced by COVID-19 pneumonia. In the first phase, we will do a retrospective review of the intermediate respiratory care unit activity from March to May 2020 in the target population. In the second phase development an interventional study. At admission all patients will be treated with HFS monitoring clinical variables like respiratory frequency, oxygen saturation, gasometer results and oxygen inspiration fraction. In case of HFO failure, the patients will be randomized to treatment with CPAP or BIPAP. The same clinical variables will be monitoring to analysis their prediction capacity of failure therapy, defined as mortality or need to intubation. The results will be adjusted comorbidity grade, age and initial severity pneumonia. Secondary objectives of study are 90 days mortality, functional recovery at 90 days and to realise a cost-effectiveness valuation of non-invasive respiratory supports in this disease.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT05094661
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of BiPAP
Trials testing the same drug.
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- NCT04258020 — Postextubation Management in Patients at Risk for Extubation Failure · NA · terminated
- NCT03235661 — Bi-level Positive Airway Pressure for Respiratory Distress Syndrome in Twins Infants · NA · unknown
Other recruiting trials for Noninvasive Ventilation
Currently open trials in the same condition.
- NCT07298889 — High PEEP in Noninvasive Ventilation Patients With Pneumonia or ARDS · NA · recruiting
- NCT06795971 — Effects of Face Mask Continuous Positive Airway Pressure Vs. Noninvasive Ventilation Vs. High-flow Nasal Oxygen on Intub · NA · recruiting
- NCT06425107 — Point-of-Care Lung Ultrasound for Prognosis in Critically Ill Infants With Acute Lower Respiratory Tract Infection · recruiting
- NCT06582459 — Efficacy and Safety of High-Flow Nasal Cannula Versus Noninvasive Ventilation for Pulmonary Arterial Hypertension-Associ · active not recruiting
- NCT07275502 — Prospective Development and Validation of an Objective Classification for Difficult Facemask Ventilation: the MASCAN Sco · active not recruiting
Other Germans Trias i Pujol Hospital trials
Trials by the same sponsor.
- NCT07064447 — Spanish Registry of Direct Cholangiopancreatoscopy by Single Operator · not yet recruiting
- NCT06670547 — Spanish Registry of Quality Indicators and Adverse Events of Endoscopic Retrograde Cholangiopancreatography · not yet recruiting
- NCT06337539 — Precision Psychiatry for Depression: Immune Response and Affective Symptoms as Predictors of Response to Antidepressants · not yet recruiting
- NCT07009054 — Program for the Promotion of Physical Exercise and Healthy Eating Among Population of Pakistani Origin With Obesity · NA · completed
- NCT07386275 — Impact of the eSalut Program in Hospital-at-Home (HOMeSALUT) · NA · completed
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 NCT05094661 (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 Germans Trias i Pujol Hospital
- Last refreshed: 8 November 2022
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/NCT05094661.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing