HFCWO in Prolonged Mechanical Ventilation Patients

Taichung Veterans General Hospital

Status: Completed

Conditions: Chronic Ventilator Dependency

Treatments: Device: HFCWO (Hill-Rom Vest™ Airway Clearance System)

Study type: Interventional

Funder types: Other

Identifiers

NCT02077738

C10216

huang5598 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 45 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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45 participants in 2 patient groups, including a placebo group

HFCWO

Experimental group

Description:

HFCWO for 15 min twice a day

Treatment:

Device: HFCWO (Hill-Rom Vest™ Airway Clearance System)

placebo

Placebo Comparator group

Description:

not to receive high-frequency chest wall oscillation (HFCWO)