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

25. mai 2018 oppdatert av: 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).

Studieoversikt

Detaljert 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.

Studietype

Intervensjonell

Registrering (Faktiske)

60

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

    • Massachusetts
      • Boston, Massachusetts, Forente stater, 02111
        • Tufts Medical Center
    • Rhode Island
      • Providence, Rhode Island, Forente stater, 02903
        • Rhode Island Hospital

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 1
Patients receiving NPPV by the 'Total Face Mask'
NPPV is applied by this mask, as long as NPPV is received.
Andre navn:
  • cephalic mask
Aktiv komparator: 2
Patients receiving NPPV by 'standard oronasal mask'
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 navn:
  • Full face mask

Hva måler studien?

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
Tiltaksbeskrivelse
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)

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Samarbeidspartnere

Etterforskere

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

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. januar 2003

Primær fullføring (Faktiske)

1. juni 2008

Studiet fullført (Faktiske)

1. juni 2008

Datoer for studieregistrering

Først innsendt

27. mai 2008

Først innsendt som oppfylte QC-kriteriene

28. mai 2008

Først lagt ut (Anslag)

29. mai 2008

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

25. juni 2018

Siste oppdatering sendt inn som oppfylte QC-kriteriene

25. mai 2018

Sist bekreftet

1. mai 2018

Mer informasjon

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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