HFCWO in Prolonged Mechanical Ventilation Patients

Study Overview
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Brief Summary
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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
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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.

Official Title
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High-frequency Chest Wall Oscillation in Prolonged Mechanical Ventilation Patients-a Randomized Controlled Trial

Conditions
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Chronic Ventilator Dependency

Intervention / Treatment
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* Device: HFCWO (Hill-Rom Vest™ Airway Clearance System)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HFCWO<br>HFCWO for 15 min twice a day | Device: HFCWO (Hill-Rom Vest™ Airway Clearance System)<br>* study subjects in the HFCWO group received HFCWO for 15 min twice a day for 5 days after extubation<br>* Other names: Hill-Rom Vest™ Airway Clearance System;|
| Placebo Comparator: placebo<br>not to receive high-frequency chest wall oscillation (HFCWO) | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effectiveness as determined by weaning success rates | 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 | 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 | 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 | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 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. | 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. | up to 5 days after extubation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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effectiveness, elderly, high frequency chest wall oscillation, mechanical ventilation, pneumonia, randomized controlled trial