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- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT00686257
Evaluation Of The Total Face Mask For Emergency Application In Acute Respiratory Failure
Panoramica dello studio
Stato
Condizioni
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
-
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Massachusetts
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Boston, Massachusetts, Stati Uniti, 02111
- Tufts Medical Center
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Rhode Island
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Providence, Rhode Island, Stati Uniti, 02903
- Rhode Island Hospital
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-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: 1
Patients receiving NPPV by the 'Total Face Mask'
|
NPPV is applied by this mask, as long as NPPV is received.
Altri nomi:
|
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Comparatore attivo: 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.
Altri nomi:
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
|---|---|
|
Mask Comfort (as Determined by the Visual Analog Scores 1 Being Least, 10 Being Most)
Lasso di tempo: During the first 3 hours of recruitment
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During the first 3 hours of recruitment
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Time Required for Mask Placement
Lasso di tempo: at the initiation of NPPV
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at the initiation of NPPV
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Early NIV Discontinuation Rate
Lasso di tempo: 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
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During hospitalization period (after recruitment into the study)
|
|
Deterioration Vital Signs
Lasso di tempo: during the first 24 hours of the study
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during the first 24 hours of the study
|
|
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Deterioration in Gas Exchange
Lasso di tempo: during the first 24 hours of the study
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during the first 24 hours of the study
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|
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Total Length of Time Requiring NIV
Lasso di tempo: during hospitalization (after recruitment)
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during hospitalization (after recruitment)
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|
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Length of Hospital Stay
Lasso di tempo: during hospitalization (after recruitment)
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during hospitalization (after recruitment)
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|
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In-hospital Mortality Rate
Lasso di tempo: during hospitalization (after recruitment)
|
during hospitalization (after recruitment)
|
Collaboratori e investigatori
Sponsor
Collaboratori
Investigatori
- Cattedra di studio: Aylin Ozsancak, MD, research fellow
- Investigatore principale: Nicholas S. Hill, MD, Chair of Pulmonary, Critical Care and Sleep Division
- Direttore dello studio: Samy Sidhom, MD, MPH, Clinical Fellow
Pubblicazioni e link utili
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- IRB-6060
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .