Chronic Ventilator DependencyNCT02077738
HFCWO in Prolonged Mechanical Ventilation Patients
A study testing HFCWO (Hill-Rom Vest™ Airway Clearance System) in people with Chronic Ventilator Dependency, run by Taichung Veterans General Hospital at 1 site in Taiwan.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Chronic Ventilator Dependency
- What is being tested?
- HFCWO (Hill-Rom Vest™ Airway Clearance System)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteTaiwan
- Study dates
- Jan 2011to Dec 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 1. those who had undergone tracheostomy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the detailed description
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.
- Conditions
- Chronic Ventilator Dependency
- Being tested
- HFCWO (Hill-Rom Vest™ Airway Clearance System)
- Keywords
- effectiveness, elderly, high frequency chest wall oscillation, mechanical ventilation, pneumonia, randomized controlled trial
- Medical subject headings
- Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HFCWO (Hill-Rom Vest™ Airway Clearance System)Device
Also called 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
| Study group | Role | What they receive |
|---|---|---|
| HFCWO | Experimental | HFCWO for 15 min twice a day Receives: Device: HFCWO (Hill-Rom Vest™ Airway Clearance System) |
| placebo | Placebo comparator | not to receive high-frequency chest wall oscillation (HFCWO) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness as determined by weaning success rates
Successful weaning was defined as continuous liberation from mechanical ventilator support longer than 5 days.
Measured: up to 5 days after extubation
Effectiveness as determined by daily clearance volume of sputum
The daily clearance volume of sputum was determined by the numbers of sputum suction per day
Measured: up to 5 days after extubation
Effectiveness as determined by serial changes in sputum coloration
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.
Measured: up to 5 days after extubation
Effectiveness as determined by chest X-ray improvement rates
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.
Measured: up to 5 days after extubation
Secondary outcomes (6)
safety as determined by the changes of blood pressures before and after HFCWO
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.
Measured: up to 5 days after extubation
safety as determined by the changes of heart rates before and after HFCWO
Heart rates (HR) was recorded before and after each HFCWO treatment by nurses who were unblinded to the study groupings.
Measured: up to 5 days after extubation
safety as determined by the changes of respiratory rates (RR) before and after HFCWO
Respiratory rates (RR) were recorded before and after each HFCWO treatment by nurses who were unblinded to the study groupings.
Measured: up to 5 days after extubation
safety as determined by the changes of oxyhemoglobin saturations by pulse oximetry (SpO2) before and after HFCWO
Oxyhemoglobin saturations by pulse oximetry (SpO2) were recorded before and after each HFCWO treatment by nurses who were unblinded to the study groupings.
Measured: up to 5 days after extubation
tolerance/comfort as determined by Modified Borg Scale (MBS)
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.
Measured: up to 5 days after extubation
tolerance/comfort as determined by Hamilton Anxiety Scale (HAS)
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.
Measured: up to 5 days after extubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2014 (estimated)
- Study startJan 2011
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Ventilator DependencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taichung Veterans General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, TCVGH, Taichung Veterans General Hospital
- Investigators
- Chieh-Liang Wu, Ph.D., Principal investigator, Taichung Veterans General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02077738
- Sponsor's protocol ID
- C10216
- Other IDs
- huang5598
- Status last verified
- Mar 2014
- First submitted
- 20 Feb 2014
- Last updated
- 4 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High-frequency Chest Wall Oscillation in Prolonged Mechanical Ventilation Patients-a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02077738
- Acronym / sponsor ID
- C10216
- Conditions
- Chronic Ventilator Dependency
- Keywords
- effectiveness, elderly, high frequency chest wall oscillation, mechanical ventilation, pneumonia, randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Taichung Veterans General HospitalUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 4 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HFCWO | Experimental | Device: HFCWO (Hill-Rom Vest™ Airway Clearance System)HFCWO for 15 min twice a day |
| placebo | Placebo comparator | –not to receive high-frequency chest wall oscillation (HFCWO) |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (1 listed)
- 1. those who had undergone tracheostomy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HFCWO (Hill-Rom Vest™ Airway Clearance System)Also: Hill-Rom Vest™ Airway Clearance Systemstudy subjects in the HFCWO group received HFCWO for 15 min twice a day for 5 days after extubation | Device | HFCWO |
Primary outcome
Effectiveness as determined by weaning success rates
Time frame: up to 5 days after extubation
Successful weaning was defined as continuous liberation from mechanical ventilator support longer than 5 days.
Effectiveness as determined by daily clearance volume of sputum
Time frame: up to 5 days after extubation
The daily clearance volume of sputum was determined by the numbers of sputum suction per day
Effectiveness as determined by serial changes in sputum coloration
Time frame: 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.
Effectiveness as determined by chest X-ray improvement rates
Time frame: 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.
6 secondary outcomes
safety as determined by the changes of blood pressures before and after HFCWO
Time frame: up to 5 days after extubation
safety as determined by the changes of heart rates before and after HFCWO
Time frame: up to 5 days after extubation
safety as determined by the changes of respiratory rates (RR) before and after HFCWO
Time frame: up to 5 days after extubation
safety as determined by the changes of oxyhemoglobin saturations by pulse oximetry (SpO2) before and after HFCWO
Time frame: up to 5 days after extubation
tolerance/comfort as determined by Modified Borg Scale (MBS)
Time frame: up to 5 days after extubation
tolerance/comfort as determined by Hamilton Anxiety Scale (HAS)
Time frame: up to 5 days after extubation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chieh-Liang Wu, Ph.D. principal investigator
Taichung Veterans General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HFCWO (Hill-Rom Vest™ Airway Clearance System) in people with Chronic Ventilator Dependency, run by Taichung Veterans General Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effectiveness as determined by weaning success rates (time frame: up to 5 days after extubation). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2014.