The ROTAtional-USE of Interface STUDY

Launched by AZIENDA OSPEDALIERO UNIVERSITARIA MAGGIORE DELLA CARITA · Aug 22, 2022

Keywords

ClinConnect Summary

The ROTAtional-USE of Interface STUDY is a clinical trial that aims to find out if changing the type of masks used during a treatment called noninvasive positive pressure ventilation (NPPV) can help reduce the occurrence of pressure sores in patients with serious breathing problems. This treatment is often given to patients with conditions like chronic obstructive pulmonary disease (COPD) or acute respiratory failure to help them breathe without needing a breathing tube. The trial will compare this rotating mask approach to standard care to see if it is both effective and cost-efficient.

To participate in this study, individuals must be at least 18 years old and have specific breathing issues that require NPPV for at least 24 hours. However, certain patients will not be eligible, such as those with skin problems where the mask would sit, or those who are pregnant. Participants can expect to follow the study protocol while receiving care in the hospital, and their involvement may help improve treatment approaches for others in the future. If you or a loved one is considering participation, it’s essential to discuss any questions or concerns with the healthcare team.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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.
• Exclusion Criteria:
• • 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);
• • Patients entering hospital with asthma, with cardiogenic pulmonary edema;
• • Patients with tracheostomy;
• • Patients needing NPPV only for palliation of symptoms (relief of dyspnea) i.e., category 3 defined by the Task Force on the Palliative Use of NPPV of the Society of Critical Care Medicine;
• • Use of high flow nasal cannula integrated with NPPV for weaning strategy;
• • Pre-existing skin erythematosus diseases;
• • Known hypersensitivity to skin protective devices (i.e., polyurethan films, colloids, foams);
• • More than 2 hours of NPPV application before randomization;
• • Patients already included in the study protocol at an earlier stage of the hospitalization;
• • Refuse to wear NPPV interface due to comfort;