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).
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.
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);
Parallel
Protocolized rotational use of interfaces
Procedure/SurgeryThe NIV mask will be changed every 6 hours, alternating two different interfaces between the two most used in that center among those available i.e., oro-nasal, total face or hybrid mask.
Standard of care
Procedure/SurgeryMask 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. Interface will be changed in case of discomfort judged by the patient as unbearable or in case of the presence of a pressure sore.
Proportion of patients who develop new pressure sores
To determine if a protocolized rotational use of interfaces during NPPV compared to standard care is effective in reducing the development of new pressure sores in patients with AHRF treated continuously i.e., for more than 24 hours, with NIV (to avoid intubation, as alternative to invasive ventilation, and during early extubation and weaning).
Onset of pressure sores at different timepoints
To determine if a protocolized rotational use of interfaces during NPPV compared to standard care is effective in reducing the development of new pressure sores in patients with AHRF treated continuously i.e., for more than 24 hours, with NPPV (to avoid intubation, as alternative to invasive ventilation, and during early extubation and weaning).
Number, stage and location of pressure sores
Pressure sores will be counted, staged (Stage I, II, III, IV, Unstageable, Suspected Deep tissue Injury) and localized.
NPPV treatment interruption
The study will also monitor the number of patients that will interrupt NPPV treatment for discomfort, the presence of eyes irritation, the adherence to the protocol (duration of NPPV treatment/day, interface change, hygiene protocol application).
Cost-effectiveness analysis
The economic impact of the protocolized rotational use of interfaces will be assessed through a cost-effectiveness analysis evaluating the additional costs needed to avoid a pressure sore due to the planned intervention as well as the costs needed to actively treat skin ulcers due to failure of preventing measures in both groups of patients.
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Azienda Ospedaliero Universitaria Maggiore della Carita
Lead sponsor
Università degli Studi del Piemonte Orientale Amedeo Avogadro
Collaborator
