Denna sida har översatts automatiskt och översättningens korrekthet kan inte garanteras. Vänligen se engelsk version för en källtext.

HFCWO in Prolonged Mechanical Ventilation Patients

2 mars 2014 uppdaterad av: 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.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Faktisk)

45

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

20 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: HFCWO
HFCWO for 15 min twice a day
Enhet: 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
Andra namn:
  • Hill-Rom Vest™ Airway Clearance System
Placebo-jämförare: placebo
not to receive high-frequency chest wall oscillation (HFCWO)

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Effectiveness as determined by weaning success rates
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
safety as determined by the changes of blood pressures before and after HFCWO
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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)
Tidsram: 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)
Tidsram: 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Taichung Veterans General Hospital

Utredare

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

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 januari 2011

Primärt slutförande (Faktisk)

1 december 2012

Avslutad studie (Faktisk)

1 december 2012

Studieregistreringsdatum

Först inskickad

20 februari 2014

Först inskickad som uppfyllde QC-kriterierna

2 mars 2014

Första postat (Uppskatta)

4 mars 2014

Uppdateringar av studier

Senaste uppdatering publicerad (Uppskatta)

4 mars 2014

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

2 mars 2014

Senast verifierad

1 mars 2014

Mer information

Termer relaterade till denna studie

Nyckelord

Andra studie-ID-nummer

  • C10216
  • huang5598 (Annan identifierare: Taichung VGH)

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

Kliniska prövningar på Chronic Ventilator Dependency

Kliniska prövningar på HFCWO (Hill-Rom Vest™ Airway Clearance System)

Sök liknande försök

Sponsorer och medarbetare

Medicinska tillstånd

Läkemedelsinterventioner

CROs by country

CROs in Austria

Betingelser

Sällsynta sjukdomar

Läkemedelsinterventioner

Kosttillskott

Sponsor / medarbetare

Platser

3
Prenumerera