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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
45
study subjects in the HFCWO group received HFCWO for 15 min twice a day for 5 days after extubation
Taichung Veterans General Hospital
Taichung, Taiwan
Effectiveness as determined by weaning success rates
Successful weaning was defined as continuous liberation from mechanical ventilator support longer than 5 days.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: up to 5 days after extubation
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.
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Time frame: 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.
Time frame: 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.
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
Oxyhemoglobin saturations by pulse oximetry (SpO2) were recorded before and after each HFCWO treatment by nurses who were unblinded to the study groupings.
Time frame: 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.
Time frame: 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.
Time frame: up to 5 days after extubation