The ROTAtional-USE of Interface STUDY

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAzienda Ospedaliero Universitaria Maggiore della Carita

About this trial

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).

Eligibility criteria

Qualifiers

Age>18 years old

Patients with chronic obstructive pulmonary disease (COPD) exacerbation or with AHRF of a different etiology needing NPPV to avoid intubation (pH < 7.35 with PaCO2 > 45 mmHg and partial pressure of oxygen (PaO2) < 65 mmHg plus respiratory rate > 25 breath/min with clinical signs of respiratory muscle distress); or as alternative to invasive ventilation with a forecast of treatment of at least 24 hours admitted to the intensive care unit, intermediate respiratory care unit, respiratory medicine service or internal medicine service according to hospital organization; or patients with chronic pulmonary disease intubated for a COPD exacerbation or for pneumonia who are early extubated and weaned in the intensive care unit with NPPV with a forecast of treatment of at least 24 hours.

Disqualifiers

Patient with skin breakdown or non-blanchable erythema in one of the following areas i.e., nasal bridge, nasolabial fold, cheek or scalp at hospital entrance;

Patients who refuse to consent to the study protocol;

Patient known to be pregnant;

Patients with contraindication to NPPV (lack of spontaneous breathing; gasping; anatomical or functional airway obstruction; gastrointestinal bleeding or ileus; coma; massive agitation; massive retention of secretions despite bronchoscopy and aggressive physiotherapy; hemodynamic instability (cardiogenic shock, myocardial infarction); status post upper gastrointestinal surgery);

Trial design

Treatments tested in this trial

  • Protocolized rotational use of interfaces
  • Standard of care

Treatment groups

478 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Azienda Ospedaliero Universitaria Maggiore della Carita

Lead sponsor

Università degli Studi del Piemonte Orientale Amedeo Avogadro

Collaborator