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Evaluation Of The Total Face Mask For Emergency Application In Acute Respiratory Failure

25. maj 2018 opdateret af: Tufts Medical Center
The purpose of this study is to compare the Total Face Mask™ (Respironics, Inc., Pittsburgh, PA) (covering whole face) and the standard oronasal facemask (covering nose and mouth) for the emergency treatment of patients with acute respiratory failure with the machine blowing air into the mask placed on the face (noninvasive positive pressure ventilation) (NPPV).

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Despite its demonstrated efficacy in treating selected patients with acute respiratory failure, the application of NPPV is still plagued by a substantial failure rate, ranging from below 10% to above 40%. Mask intolerance ranks as one of the most common causes of failure. This is related to ill-fitting masks, mask discomfort (despite a properly fitted mask), excessively tightened straps, excessive air leaks around the mask or through the mouth, and claustrophobia.

The most commonly used masks in the acute care setting are either oronasal masks that cover the nose and mouth, or nasal masks that cover the nose alone. Both mask types usually consist of clear plastic dome-shaped mask with a soft silicon gasket to create an air seal with the skin. While this approach is usually successful, it may lead to patient discomfort and/or an air leak secondary to the difficulty in creating an effective seal over the bridge of the nose and over mobile structures such as the mandible. The Total Face Mask ™ (Respironics, Inc., Pittsburgh, PA) uses a different approach to avoid some of these limitations. Considerably larger than a standard oronasal mask, it covers the entire face and creates an air seal using a silicon gasket around the parameter of the face. In this way, gasket pressure is more evenly distributed, and discomfort over the bridge of the nose or chin is eliminated, and air leaking reduced. In addition, because one mask size fits virtually all patients, the Total Face Mask ™ facilitates the fitting process and permits more rapid initiation of ventilatory assistance. Clinical experience to date suggests that claustrophobia is not a common problem with the Total Face Mask ™ despite its size, and that its contribution to dead space is comparable to that of most oronasal masks.

The following protocol aims to compare use of the Total Face Mask ™ to the Comfort Full oronasal mask (also by Respironics, Inc., Pittsburgh, PA)or RT040 oronasal mask (Fisher&Paykel Inc., Wellington, NZ) in the acute care setting for patients meeting standard indications for NPPV.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

60

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Massachusetts
      • Boston, Massachusetts, Forenede Stater, 02111
        • Tufts Medical Center
    • Rhode Island
      • Providence, Rhode Island, Forenede Stater, 02903
        • Rhode Island Hospital

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Age>18
  • Either A or B

A. Clinical Criteria: Moderate to severe respiratory distress as evidenced by tachypnea, use of accessory muscles for breathing, or abdominal paradox.

B. Blood Gas and Physiologic Criteria: Gas exchange abnormalities including PaCO2>45 with a pH<7.35, or a PaO2/FiO2 ratio<200.

Exclusion Criteria:

  • The need for immediate intubation
  • Medical instability such as hypotensive shock, uncontrolled cardiac ischemia or arrythmias, unstable myocardial infarction, uncontrolled upper gastrointestinal bleeding
  • Agitation or uncooperativeness, unresponsive to small doses of sedatives
  • Excretions or inability to protect the airway
  • Inability to fit the mask
  • Facial trauma
  • Upper airway obstruction

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 1
Patients receiving NPPV by the 'Total Face Mask'
Enhed: Total face mask (interface for NPPV)
NPPV is applied by this mask, as long as NPPV is received.
Andre navne:
  • cephalic mask
Aktiv komparator: 2
Patients receiving NPPV by 'standard oronasal mask'
Enhed: Comfort full or RT040 oronasal mask (interface for NPPV)
NPPV is applied by one of these masks (Comfort full or RT040 masks used at Rhode Island Hospital and Tufts Medical Center respectively), as long as NPPV is received.
Andre navne:
  • Full face mask

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Mask Comfort (as Determined by the Visual Analog Scores 1 Being Least, 10 Being Most)
Tidsramme: During the first 3 hours of recruitment
During the first 3 hours of recruitment
Time Required for Mask Placement
Tidsramme: at the initiation of NPPV
at the initiation of NPPV

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Early NIV Discontinuation Rate
Tidsramme: During hospitalization period (after recruitment into the study)
Defined as the inability of the patient to be maintained on NPPV using the assigned mask while there was still an indication for ventilatory support
During hospitalization period (after recruitment into the study)
Deterioration Vital Signs
Tidsramme: during the first 24 hours of the study
during the first 24 hours of the study
Deterioration in Gas Exchange
Tidsramme: during the first 24 hours of the study
during the first 24 hours of the study
Total Length of Time Requiring NIV
Tidsramme: during hospitalization (after recruitment)
during hospitalization (after recruitment)
Length of Hospital Stay
Tidsramme: during hospitalization (after recruitment)
during hospitalization (after recruitment)
In-hospital Mortality Rate
Tidsramme: during hospitalization (after recruitment)
during hospitalization (after recruitment)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Tufts Medical Center

Samarbejdspartnere

Rhode Island Hospital

Efterforskere

  • Studiestol: Aylin Ozsancak, MD, research fellow
  • Ledende efterforsker: Nicholas S. Hill, MD, Chair of Pulmonary, Critical Care and Sleep Division
  • Studieleder: Samy Sidhom, MD, MPH, Clinical Fellow

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. januar 2003

Primær færdiggørelse (Faktiske)

1. juni 2008

Studieafslutning (Faktiske)

1. juni 2008

Datoer for studieregistrering

Først indsendt

27. maj 2008

Først indsendt, der opfyldte QC-kriterier

28. maj 2008

Først opslået (Skøn)

29. maj 2008

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

25. juni 2018

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

25. maj 2018

Sidst verificeret

1. maj 2018

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • IRB-6060

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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