The ROTAtional-USE of Interface STUDY (ROTA-USE)
Pressure Ulcer, Noninvasive Positive Pressure Ventilation, Acute Hypercapnic Respiratory Failure
About this trial
This is an interventional treatment trial for Pressure Ulcer focused on measuring Rotational use of noninvasive interfaces
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;
Sites / Locations
- Ospedale Maggiore della CaritàRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Intervention group
Control group
In the intervention group the first mask will be randomly chosen between the two most used in that center among those available i.e., oro-nasal, total face or hybrid mask. Thereafter, NPPV mask will be changed every 6 hours, alternating the two different interfaces. Patients wearing oro-nasal masks will receive protective dressings on nasal bridge before starting NPPV.
In the control group, mask will be chosen according to the standard of care of the participating centers among the three types of masks available i.e., oro-nasal, total face or hybrid mask. Patients wearing oro-nasal masks will receive protective dressings on nasal bridge before starting NPPV. Interface will be changed in case of discomfort judged by the patient as unbearable or in case of the presence of a pressure sore.