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HFCWO in Prolonged Mechanical Ventilation Patients

2 marzo 2014 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

45

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Taiwan
      • Taichung, Taiwan, 40705
        • Taichung Veterans General Hospital

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

20 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion Criteria:

  1. continuous intra-tracheal intubation and mechanical ventilator support for at least 21 days
  2. age ≥20 year-old
  3. having an acute or chronic pulmonary condition requiring secretion mobilization as judged by the physician
  4. alert consciousness; completion of the Modified Borg Scale (MBS) and Hamilton Anxiety Scale (HAS)
  5. scheduled extubation within 24 hours after enrollment
  6. 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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

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: HFCWO
HFCWO for 15 min twice a day
Dispositivo: HFCWO (Hill-Rom Vest™ Airway Clearance System)
study subjects in the HFCWO group received HFCWO for 15 min twice a day for 5 days after extubation
Altri nomi:
  • Hill-Rom Vest™ Airway Clearance System
Comparatore placebo: placebo
not to receive high-frequency chest wall oscillation (HFCWO)

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Effectiveness as determined by weaning success rates
Lasso di tempo: up to 5 days after extubation
Successful weaning was defined as continuous liberation from mechanical ventilator support longer than 5 days.
up to 5 days after extubation
Effectiveness as determined by daily clearance volume of sputum
Lasso di tempo: up to 5 days after extubation
The daily clearance volume of sputum was determined by the numbers of sputum suction per day
up to 5 days after extubation
Effectiveness as determined by serial changes in sputum coloration
Lasso di tempo: up to 5 days after extubation
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.
up to 5 days after extubation
Effectiveness as determined by chest X-ray improvement rates
Lasso di tempo: up to 5 days after extubation
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.
up to 5 days after extubation

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
safety as determined by the changes of blood pressures before and after HFCWO
Lasso di tempo: up to 5 days after extubation
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.
up to 5 days after extubation
safety as determined by the changes of heart rates before and after HFCWO
Lasso di tempo: up to 5 days after extubation
Heart rates (HR) was recorded before and after each HFCWO treatment by nurses who were unblinded to the study groupings.
up to 5 days after extubation
safety as determined by the changes of respiratory rates (RR) before and after HFCWO
Lasso di tempo: up to 5 days after extubation
Respiratory rates (RR) were recorded before and after each HFCWO treatment by nurses who were unblinded to the study groupings.
up to 5 days after extubation
safety as determined by the changes of oxyhemoglobin saturations by pulse oximetry (SpO2) before and after HFCWO
Lasso di tempo: up to 5 days after extubation
Oxyhemoglobin saturations by pulse oximetry (SpO2) were recorded before and after each HFCWO treatment by nurses who were unblinded to the study groupings.
up to 5 days after extubation
tolerance/comfort as determined by Modified Borg Scale (MBS)
Lasso di tempo: up to 5 days after extubation
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.
up to 5 days after extubation
tolerance/comfort as determined by Hamilton Anxiety Scale (HAS)
Lasso di tempo: up to 5 days after extubation
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.
up to 5 days after extubation

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Taichung Veterans General Hospital

Investigatori

  • Investigatore principale: Chieh-Liang Wu, Ph.D., Taichung Veterans General Hospital

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 gennaio 2011

Completamento primario (Effettivo)

1 dicembre 2012

Completamento dello studio (Effettivo)

1 dicembre 2012

Date di iscrizione allo studio

Primo inviato

20 febbraio 2014

Primo inviato che soddisfa i criteri di controllo qualità

2 marzo 2014

Primo Inserito (Stima)

4 marzo 2014

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

4 marzo 2014

Ultimo aggiornamento inviato che soddisfa i criteri QC

2 marzo 2014

Ultimo verificato

1 marzo 2014

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Altri numeri di identificazione dello studio

  • C10216
  • huang5598 (Altro identificatore: Taichung VGH)

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 .

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