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RECRUITING

NCT05513508

The ROTAtional-USE of Interface STUDY

Sponsor: Azienda Ospedaliero Universitaria Maggiore della Carita

View on ClinicalTrials.gov

Summary

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).

Official title: 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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

478

Start Date

2022-12-08

Completion Date

2028-09

Last Updated

2024-11-14

Healthy Volunteers

Conditions

Pressure Ulcer Noninvasive Positive Pressure Ventilation Acute Hypercapnic Respiratory Failure

Interventions

PROCEDURE

Protocolized rotational use of interfaces

The 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.

PROCEDURE

Standard of care

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. Interface will be changed in case of discomfort judged by the patient as unbearable or in case of the presence of a pressure sore.

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;

Locations (1)

Ospedale Maggiore della Carità

Novara, Italy