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The ROTAtional-USE of Interface STUDY

NCT05513508 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 478

Last updated 2024-11-14

No results posted yet for this study

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).

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.

Sponsors & Collaborators

  • Università degli Studi del Piemonte Orientale Amedeo Avogadro

    collaborator OTHER

  • Azienda Ospedaliero Universitaria Maggiore della Carita

    lead OTHER

Principal Investigators

  • Rosanna Vaschetto, Assoc · Università degli Studi del Piemonte Orientale Amedeo Avogadro

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-12-08
Primary Completion
2027-09-30
Completion
2028-09-30

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05513508 on ClinicalTrials.gov