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HFCWO in Prolonged Mechanical Ventilation Patients

2. marts 2014 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

45

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

20 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: HFCWO
HFCWO for 15 min twice a day
Enhed: 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
Andre navne:
  • Hill-Rom Vest™ Airway Clearance System
Placebo komparator: placebo
not to receive high-frequency chest wall oscillation (HFCWO)

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Effectiveness as determined by weaning success rates
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
safety as determined by the changes of blood pressures before and after HFCWO
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Taichung Veterans General Hospital

Efterforskere

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

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. januar 2011

Primær færdiggørelse (Faktiske)

1. december 2012

Studieafslutning (Faktiske)

1. december 2012

Datoer for studieregistrering

Først indsendt

20. februar 2014

Først indsendt, der opfyldte QC-kriterier

2. marts 2014

Først opslået (Skøn)

4. marts 2014

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

4. marts 2014

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

2. marts 2014

Sidst verificeret

1. marts 2014

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

  • C10216
  • huang5598 (Anden identifikator: Taichung VGH)

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