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The ROTAtional-USE of Interface STUDY

Study acronym: ROTA-USE
StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Primary completion date: Sep 2024 to Sep 2027
    • Study completion date: Sep 2025 to Sep 2028
    v4
  2. Trial status: Not Yet Recruiting to Recruitingv3 Show 5 more changesShow less
    • Study sites: 0 to 1
    • Start date changed from estimate of Oct 2022 to Dec 8, 2022
    • Study description shortened, about 30 words
    • Study title revised
    • Eligibility criteria expanded, about 1 word
  3. Study description shortened, about 457 wordsv2
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
In this trial investigators will explore if a protocolized rotational use of interfaces i.e., masks, during noninvasive positive pressure ventilation (NPPV) compared to standard care is clinically effective and cost-effective in reducing the incidence of pressure sores in patients with hypercapnic acute respiratory failure (AHRF) treated continuously i.e., for more than 24 hours, with NPPV (to avoid intubation, as alternative to invasive ventilation and after early extubation and weaning).
Trial Details
NCT Number NCT05513508
Lead Sponsor Azienda Ospedaliero Universitaria Maggiore della Carita
Collaborators: Università degli Studi del Piemonte Orientale Amedeo Avogadro
Conditions
(from sponsor)		 Pressure Ulcer, Noninvasive Positive Pressure Ventilation, Acute Hypercapnic Respiratory Failure
Related terms Pressure Ulcer, Respiratory Insufficiency
Enrollment 478 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov