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New treatment option for Pressure Ulcer
Official title The ROTAtional-USE of Interface STUDY
ClinicalTrials.gov ID: NCT05513508
What this study is testing
- What it's testing
- 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).
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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 \...
You likely can't join if
- 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...
- 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...
- Patients entering hospital with asthma, with cardiogenic pulmonary edema;
- Patients with tracheostomy;
See the full eligibility 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 \ 45 mmHg and partial pressure of oxygen (PaO2) \ 25 breath/min with...
- 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...
- 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;
The study team makes the final eligibility decision.
Where it's taking place
- Novara, Italy
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Novara, Italy. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.