- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00686257
Evaluation Of The Total Face Mask For Emergency Application In Acute Respiratory Failure
Studieoversikt
Status
Forhold
Intervensjon / Behandling
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
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
Massachusetts
-
Boston, Massachusetts, Forente stater, 02111
- Tufts Medical Center
-
-
Rhode Island
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Providence, Rhode Island, Forente stater, 02903
- Rhode Island Hospital
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
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
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:
|
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:
|
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
Sponsor
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
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- IRB-6060
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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