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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Ospedale Maggiore della Carità
  Novara, Italy Recruiting

Study contacts

• Study coordinator: Rosanna Vaschetto, Assoc
• Email: rosanna.vaschetto@med.uniupo.it
• Phone: +393342724811

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.