Chronic Ventilator Dependency
Conditions
Keywords
effectiveness, elderly, high frequency chest wall oscillation, mechanical ventilation, pneumonia, randomized controlled trial
Brief 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 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.
Interventions
DEVICEHFCWO (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
Sponsors
Taichung Veterans General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effectiveness as determined by weaning success rates | 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 | 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 | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| tolerance/comfort as determined by Modified Borg Scale (MBS) | 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. |
| safety as determined by the changes of blood pressures before and after HFCWO | 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. |
| tolerance/comfort as determined by Hamilton Anxiety Scale (HAS) | 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. |
| safety as determined by the changes of heart rates before and after HFCWO | 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. |
| safety as determined by the changes of respiratory rates (RR) before and after HFCWO | 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. |
| safety as determined by the changes of oxyhemoglobin saturations by pulse oximetry (SpO2) before and after HFCWO | 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. |
Countries
Taiwan
Outcome results
None listed