Using different masks to prevent pressure sores in patients with respiratory failure

A Pragmatic Open Label, Multi-center, Spontaneous, No-profit, Randomized Controlled Clinical Trial With Non-significant Risk Medical Device on the Rotational Use of Interfaces Versus Standard of Care for Patients Treated With NPPV for AHRF.

This study tests if using different types of masks during breathing support can help prevent pressure sores in patients with severe breathing problems.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 478 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Azienda Ospedaliero Universitaria Maggiore della Carita (Academic / other)
• Locations: 1 site (Novara)
• Trial ID: NCT05513508 on ClinicalTrials.gov

What this trial studies

This trial investigates the effectiveness of a protocolized rotational use of masks during noninvasive positive pressure ventilation (NPPV) compared to standard care in reducing pressure sores in patients with acute hypercapnic respiratory failure. The study will monitor the incidence of new pressure sores at various time points and assess patient comfort and adherence to the protocol. Additionally, it will evaluate the economic impact of this approach on healthcare costs. The trial aims to provide evidence on whether this method can improve patient outcomes and reduce complications associated with prolonged NPPV.

Who should consider this trial

Good fit: Ideal candidates are adults over 18 with acute hypercapnic respiratory failure requiring noninvasive positive pressure ventilation for at least 24 hours.

Not a fit: Patients with existing skin breakdown or non-blanchable erythema in specific facial areas will not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly reduce the incidence of pressure sores in patients undergoing prolonged noninvasive ventilation.

How similar studies have performed: Other studies have shown promising results with similar approaches to pressure sore prevention in ventilated patients, suggesting potential for success.

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;

Where this trial is running

Novara

• Ospedale Maggiore della Carità — Novara, Italy (Recruiting)

Study contacts

• Study coordinator: Rosanna Vaschetto, Assoc

Conditions Pressure Ulcer; Noninvasive Positive Pressure Ventilation; Acute Hypercapnic Respiratory Failure; Rotational use of noninvasive interfaces