Clinical trial NCT02077738: HFCWO in Prolonged Mechanical Ventilation Patients
Official title: High-frequency Chest Wall Oscillation in Prolonged Mechanical Ventilation Patients-a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Ventilator Dependency
Keywords: effectiveness
elderly
high frequency chest wall oscillation
mechanical ventilation
pneumonia
randomized controlled trial
Lead sponsor: Taichung Veterans General Hospital
Sponsor class: OTHER
First posted: 2014-03-04
Enrollment: 45
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Effectiveness as determined by weaning success rates
timeFrame: up to 5 days after extubation
measure: Effectiveness as determined by daily clearance volume of sputum
timeFrame: up to 5 days after extubation
measure: Effectiveness as determined by serial changes in sputum coloration
timeFrame: up to 5 days after extubation
measure: Effectiveness as determined by chest X-ray improvement rates
timeFrame: up to 5 days after extubation
Secondary outcomes:
measure: safety as determined by the changes of blood pressures before and after HFCWO
timeFrame: up to 5 days after extubation
measure: safety as determined by the changes of heart rates before and after HFCWO
timeFrame: up to 5 days after extubation
measure: safety as determined by the changes of respiratory rates (RR) before and after HFCWO
timeFrame: up to 5 days after extubation
measure: safety as determined by the changes of oxyhemoglobin saturations by pulse oximetry (SpO2) before and after HFCWO
timeFrame: up to 5 days after extubation
measure: tolerance/comfort as determined by Modified Borg Scale (MBS)
timeFrame: up to 5 days after extubation
measure: tolerance/comfort as determined by Hamilton Anxiety Scale (HAS)
timeFrame: up to 5 days after extubation
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital
Study officials:
affiliation: Taichung Veterans General Hospital
name: Chieh-Liang Wu, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: