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NCT06113432
CPAP Therapy Through a Helmet or a Full Face Mask in Patients With Acute Hypoxemic Respiratory Failure: Cross-over Study
NA trial testing Arterial blood gases in Pneumonia, Bacterial in 30 participants. Completed in 30 May 2024.
30 May 2024
Quick facts
| Lead sponsor | I.M. Sechenov First Moscow State Medical University |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 30 |
| Start date | 19 September 2023 |
| Primary completion | 30 May 2024 |
| Estimated completion | 30 May 2024 |
| Sites | 1 location across Russia |
Drugs / interventions tested
- Arterial blood gases
- Respiratory rate (RR)
- Pulseoximeter
- Assessment of accessory respiratory muscles work
- Esophageal pressure measurement
- Discomfort Visual Analog Scale (VAS)
- Noninvasive blood pressure
- Heart rate
Conditions studied
- Pneumonia, Bacterial — all drugs for Pneumonia, Bacterial →
- Respiratory Failure — all drugs for Respiratory Failure →
- COVID-19 Pneumonia — all drugs for COVID-19 Pneumonia →
Sponsor
I.M. Sechenov First Moscow State Medical University
Who can join
18 and older, any sex, with Pneumonia, Bacterial or Respiratory Failure. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Observational and randomized trials have demonstrated the high effectiveness of non-invasive helmet ventilatory support, demonstrating a reduction in intubation rate mortality compared with high-flow and standard oxygen therapy. Some pilot physiological studies have shown physiological benefits of helmets compared to the oronasal mask for non-invasive ventilation. The purpose of the study is to compare markers of patient self-inflicted lung injury (P-SILI), patient's comfort, work of breathing, gas exchange, and hemodynamics in patients with acute hypoxemic respiratory failure (AHRF) during non-invasive ventilation (NIV) in continuous positive pressure (CPAP) mode during an oronasal mask ventilation or a combination of a helmet with high-flow oxygenation as an air flow generator.
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 NCT06113432
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Pneumonia, Bacterial
Currently open trials in the same condition.
- NCT07428759 — Trial to Evaluate Safety and Immune Response of an Investigational Pneumococcal Vaccine in Adults Aged 50 To 64 Years · Phase 1 · recruiting
- NCT07105722 — A Trial to Evaluate the Safety and Immune Response of an Investigational Pneumococcal Vaccine in Adults 50 To 64 Years o · Phase 1 · active not recruiting
- NCT06238297 — Rapid De-escalation of Anti-MRSA Therapy Guided by S. Aureus Nares Screening in Case of Pneumonia · NA · recruiting
- NCT05776004 — Blinded Efficacy and Safety Study of CAL02 IV Plus SOC in Subjects With Severe Community-Acquired Bacterial Pneumonia · Phase 2 · active not recruiting
Other I.M. Sechenov First Moscow State Medical University trials
Trials by the same sponsor.
- NCT07348991 — Predicting Severe Cardiac Arrhythmias in the Perioperative Period Using AI-ECG · not yet recruiting
- NCT07412457 — Guideline Adherence in Dyslipidemia With Clinical Decision Support · not yet recruiting
- NCT07396792 — Screening for Cardiac and Cardiac-associated Pathology Using Single-channel Electrocardiogram · not yet recruiting
- NCT07412418 — Screening for Pulmonary Embolism Using Single-channel Electrocardiogram · not yet recruiting
- NCT07518550 — Maternal and Fetal Electrocardiograms Separation Algorithm · NA · 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 NCT06113432 (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 I.M. Sechenov First Moscow State Medical University
- Last refreshed: 18 June 2024
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/NCT06113432.
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