Actively Recruiting
The ROTAtional-USE of Interface STUDY
Led by Azienda Ospedaliero Universitaria Maggiore della Carita · Updated on 2024-11-14
478
Participants Needed
1
Research Sites
299 weeks
Total Duration
On this page
Sponsors
A
Azienda Ospedaliero Universitaria Maggiore della Carita
Lead Sponsor
U
Università degli Studi del Piemonte Orientale Amedeo Avogadro
Collaborating Sponsor
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
The ROTAtional-USE of Interface STUDY
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age greater than 18 years
- Patients with COPD exacerbation or acute hypercapnic respiratory failure needing NPPV to avoid intubation or as an alternative to invasive ventilation with expected treatment of at least 24 hours
- Patients admitted to intensive care unit, intermediate respiratory care unit, respiratory medicine service, or internal medicine service
- Patients with chronic pulmonary disease intubated for COPD exacerbation or pneumonia who are early extubated and weaned with NPPV with expected treatment of at least 24 hours
You will not qualify if you...
- Skin breakdown or non-blanchable redness on nasal bridge, nasolabial fold, cheek, or scalp at hospital entry
- Refusal to consent to study
- Known pregnancy
- Contraindications to NPPV (lack of spontaneous breathing, gasping, airway obstruction, gastrointestinal bleeding or ileus, coma, severe agitation, retention of secretions despite bronchoscopy and physiotherapy, hemodynamic instability, status post upper gastrointestinal surgery)
- Hospital admission for asthma or cardiogenic pulmonary edema
- Presence of tracheostomy
- NPPV use only for symptom relief (palliation)
- Use of high flow nasal cannula integrated with NPPV for weaning
- Pre-existing skin erythematosus diseases
- Known allergy to skin protective devices
- More than 2 hours of NPPV before randomization
- Previous enrollment in this study during current hospitalization
- Refusal to wear NPPV interface due to comfort
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Ospedale Maggiore della Carità
Novara, Italy, 28100
Actively Recruiting
Research Team
R
Rosanna Vaschetto, Assoc
CONTACT
N
Nello De Vita, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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