Under the Nose Face Mask to Prevent Facial Pressure Ulcers During NIV for Acute Hypercapnic Respiratory Failure (AHRF) (UNDER PRESSURE)

March 14, 2022 updated by: Centre Hospitalier Arras

UNDER the Nose vs. Over the Nose Face Mask to Prevent Facial PRESSURE Ulcers During Face Mask-noninvasive Ventilation for Acute Hypercapnic Respiratory Failure

Noninvasive ventilation (NIV) is essential to treat acute hypercapnic respiratory failure. However, facial pressure ulcers appearing during facemask-delivered noninvasive ventilation are a source of NIV failure by interface intolerance.

A Philips facemask (model : AF541 SE Oro-Nasal mask) has the particularity to display two options for its positioning : a usually used "over-the-nose" positioning or an "under-the-nose" positioning that is supposed to reduce the incidence of facial pressure ulcers while keeping in the same time the qualities of a standard facemask.

The goal of this controlled randomized trial is to test the hypothesis that the "under-the-nose" positioning actually reduces the incidence of facial pressure ulcers, compared to the usually used "over-the-nose" positioning.

Results of this trial should lead to the proposition of a new interface strategy to prevent facial pressure ulcers and therefore to improve the tolerance of NIV via the use of facemasks displaying an "under-the-nose" positioning.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
108

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Arras, France
        • Centre Hospitalier ARRAS
      • Lens, France
        • Centre Hospitalier Lens

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Acute hypercapnic respiratory failure
  • Initiation of NIV
  • Estimated cumulative time of NIV upper than 12 hours for the first 48 hours of hospitalization

Exclusion Criteria:

  • Contraindication for NIV (respiratory arrest, impossibility to fit the mask)
  • Intubated patient
  • Patient with a tracheostomy
  • Post-extubation respiratory failure
  • Patient exhibiting facial ulcers or skin lesions located at the insertion points of the mask before its hospitalization
  • Person declining NIV
  • Pregnancy
  • Dying person

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
ACTIVE_COMPARATOR: Over-the-nose facemask
The AF541 oro-nasal mask is used with the over-the-nose mask cushion.
Device: Over-the-nose facemask
Patients with acute hypercapnic respiratory failure that need non-invasive ventilation and are randomized in the comparator group will receive the AF541 facemask used with the over-the-nose cushion.
EXPERIMENTAL: Under-the-nose facemask
The AF541 oro-nasal mask is used with the under-the-nose mask cushion.
Device: Under-the-nose facemask
Patients with acute hypercapnic respiratory failure that need noninvasive ventilation and are randomized in the experimental group will receive the AF541 facemask used with the under-the-nose cushion.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change of the incidence of facial pressure ulcers in the experimental arm compared to the control arm, within the first 3 days after NIV initiation.
Time Frame: 3 days after NIV initiation
The primary endpoint is the development of a facial pressure ulcer within the first 3 days after NIV initiation
3 days after NIV initiation

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change of the delay for facial pressure ulcers to appear in the experimental arm, compared to the control arm
Time Frame: 7 days after NIV initiation
This secondary endpoint is the delay (in hours) between NIV initiation and the development of a facial pressure ulcer.
7 days after NIV initiation
Change of the severity of facial pressure ulcers in the experimental arm, compared to the control arm
Time Frame: 7 days after NIV initiation
This secondary endpoint is the highest facial pressure ulcer severity score observed during patient hospitalization. This score is evaluated according to the National Pressure Ulcer Advisory Panel guidelines (Edsberg LE et al., 2016). Stage 1 pressure injury (the less severe score) corresponds to intact skin with a localized area of nonblanchable erythema. Stage 2 pressure injury corresponds to partial-thickness skin loss with exposed dermis. Stage 3 pressure injury corresponds to full-thickness skin loss. Stage 4 pressure injury (the most severe score) corresponds to full-thickness skin and tissue loss.
7 days after NIV initiation
Change of the patient comfort in the experimental arm, compared to the control arm
Time Frame: 24 hours after NIV initiation
This secondary endpoint is the comfort patient score at 24 hours after NIV initiation. This score is a numeric scale, validated for NIV (Lemyze M et al., 2013 ; Gregoretti C et al., 2002), going from 1 to 5 (1: very uncomfortable ; 2: uncomfortable ; 3: acceptable ; 4: quite comfortable ; 5: comfortable).
24 hours after NIV initiation
Change of the incidence of mask changes related to interface intolerance in the experimental arm, compared to the control arm
Time Frame: 7 days after NIV initiation
This secondary endpoint is the incidence of mask changes related to interface intolerance during patient hospitalization.
7 days after NIV initiation
Change of the incidence of NIV failure in the experimental arm, compared to the control arm
Time Frame: 7 days after NIV initiation
This secondary endpoint is the incidence of NIV failure defined as the need to resort to intubation or palliative care (in the case of a do-not-intubate order) during patient hospitalization. NIV failures may be caused by refractory respiratory acidosis, refractory hypoxemia, pressure ulcers, interface intolerance, excessive unintentional air leaks or shock.
7 days after NIV initiation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Centre Hospitalier Arras

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 21, 2018

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 3, 2021

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 3, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 17, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 24, 2019

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 25, 2019

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 15, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 14, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2017-02

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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