HFCWO in Prolonged Mechanical Ventilation Patients
2. března 2014 aktualizováno: TCVGH, Taichung Veterans General Hospital
High-frequency Chest Wall Oscillation in Prolonged Mechanical Ventilation Patients-a Randomized Controlled Trial
The effectiveness, safety and tolerance/comfort of high-frequency chest wall oscillation (HFCWO) in prolonged mechanical ventilation patients remain unknown.
This study aimed to test the hypothesis that HFCWO could produce greater clearance volume of sputum, greater improvement rates in serial changes in the chest X-ray (CXR), and greater weaning success rates after extubation in Prolonged Mechanical Ventilation (PMV) patients with intra-tracheal intubation.
Přehled studie
Postavení
Dokončeno
Podmínky
Intervence / Léčba
Detailní popis
For over 20 years, studies have attempted to examine the effectiveness, safety and tolerance/comfort of HFCWO in the management of surgical and non-surgical patients who had impaired bronchial secretion clearance, including those with neuromuscular disorders, chronic obstructive pulmonary disease, cystic fibrosis, and blunt thoracic trauma, or those hospitalized for critical cardiac/abdominal/thoracic surgery. However, these outcomes of HFCWO on PMV patients remain unknown.
This parallel-design, randomized controlled trial aimed to test the hypothesis that HFCWO could produce greater clearance volume of sputum, greater improvement rates in serial changes in the chest X-ray (CXR), and greater weaning success rates after extubation in PMV patients with intra-tracheal intubation. Moreover, the safety and tolerance/comfort of HFCWO in PMV patients after removal of endotracheal tubes were also evaluated.
Typ studie
Intervenční
Zápis (Aktuální)
45
Fáze
- Nelze použít
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní místa
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Taichung, Tchaj-wan, 40705
- Taichung Veterans General Hospital
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Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
20 let a starší (Dospělý, Starší dospělý)
Přijímá zdravé dobrovolníky
Ne
Pohlaví způsobilá ke studiu
Všechno
Popis
Inclusion Criteria:
- continuous intra-tracheal intubation and mechanical ventilator support for at least 21 days
- age ≥20 year-old
- having an acute or chronic pulmonary condition requiring secretion mobilization as judged by the physician
- alert consciousness; completion of the Modified Borg Scale (MBS) and Hamilton Anxiety Scale (HAS)
- scheduled extubation within 24 hours after enrollment
- without any contraindication for HFCWO (i.e., recent spinal injuries which have not yet been stabilized and active hemorrhage with hemodynamic instability)
Exclusion Criteria:
1. those who had undergone tracheostomy
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Experimentální: HFCWO
HFCWO for 15 min twice a day
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study subjects in the HFCWO group received HFCWO for 15 min twice a day for 5 days after extubation
Ostatní jména:
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Komparátor placeba: placebo
not to receive high-frequency chest wall oscillation (HFCWO)
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Effectiveness as determined by weaning success rates
Časové okno: up to 5 days after extubation
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Successful weaning was defined as continuous liberation from mechanical ventilator support longer than 5 days.
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up to 5 days after extubation
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Effectiveness as determined by daily clearance volume of sputum
Časové okno: up to 5 days after extubation
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The daily clearance volume of sputum was determined by the numbers of sputum suction per day
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up to 5 days after extubation
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Effectiveness as determined by serial changes in sputum coloration
Časové okno: up to 5 days after extubation
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The sputum coloration was determined by the Color Card for Body Fluid (CCBF).
The CCBF was designed to have 27 different categories to describe the color of the body fluid.
Each category was assigned an Arabic numeral and the larger the Arabic numeral, the darker the color of the body fluid.
The scoring of sputum coloration was based on the perception of the interviewer who was blinded to the intervention.
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up to 5 days after extubation
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Effectiveness as determined by chest X-ray improvement rates
Časové okno: up to 5 days after extubation
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Baseline and follow-up CXRs were taken on the day of extubation and on the 5th day after extubation, respectively, in both groups.
Serial changes in CXR were graded as "improved", "no change", or "progressed", as determined by the severity of lung infiltrates, which were defined by two independent chest specialists blinded to the study groupings.
If no consistency between two specialists, the grading would be judged by the third chest specialist.
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up to 5 days after extubation
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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safety as determined by the changes of blood pressures before and after HFCWO
Časové okno: up to 5 days after extubation
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systolic blood pressure (SBP) and diastolic blood pressure (DBP) were recorded before and after each HFCWO treatment by nurses who were unblinded to the study groupings.
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up to 5 days after extubation
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safety as determined by the changes of heart rates before and after HFCWO
Časové okno: up to 5 days after extubation
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Heart rates (HR) was recorded before and after each HFCWO treatment by nurses who were unblinded to the study groupings.
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up to 5 days after extubation
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safety as determined by the changes of respiratory rates (RR) before and after HFCWO
Časové okno: up to 5 days after extubation
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Respiratory rates (RR) were recorded before and after each HFCWO treatment by nurses who were unblinded to the study groupings.
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up to 5 days after extubation
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safety as determined by the changes of oxyhemoglobin saturations by pulse oximetry (SpO2) before and after HFCWO
Časové okno: up to 5 days after extubation
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Oxyhemoglobin saturations by pulse oximetry (SpO2) were recorded before and after each HFCWO treatment by nurses who were unblinded to the study groupings.
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up to 5 days after extubation
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tolerance/comfort as determined by Modified Borg Scale (MBS)
Časové okno: up to 5 days after extubation
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MBS was measured before and after treatment in HFCWO group and at the same time in non-HFCWO group by the interviewer who was blinded to the intervention from the day of extubation to the 5th post-extubation day.
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up to 5 days after extubation
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tolerance/comfort as determined by Hamilton Anxiety Scale (HAS)
Časové okno: up to 5 days after extubation
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HAS was measured before and after treatment in HFCWO group and at the same time in non-HFCWO group by the interviewer who was blinded to the intervention from the day of extubation to the 5th post-extubation day.
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up to 5 days after extubation
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Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Vyšetřovatelé
- Vrchní vyšetřovatel: Chieh-Liang Wu, Ph.D., Taichung Veterans General Hospital
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia
1. ledna 2011
Primární dokončení (Aktuální)
1. prosince 2012
Dokončení studie (Aktuální)
1. prosince 2012
Termíny zápisu do studia
První předloženo
20. února 2014
První předloženo, které splnilo kritéria kontroly kvality
2. března 2014
První zveřejněno (Odhad)
4. března 2014
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Odhad)
4. března 2014
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
2. března 2014
Naposledy ověřeno
1. března 2014
Více informací
Termíny související s touto studií
Klíčová slova
Další identifikační čísla studie
- C10216
- huang5598 (Jiný identifikátor: Taichung VGH)
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .