HFCWO in Prolonged Mechanical Ventilation Patients

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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Ventilator Dependency
• Intervention / Treatment: Device: HFCWO (Hill-Rom Vest™ Airway Clearance System)

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.

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taichung, Taiwan, 40705
    • Taichung Veterans General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HFCWO; HFCWO for 15 min twice a day	Device: HFCWO (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; Other Names: Hill-Rom Vest™ Airway Clearance System
Placebo Comparator: placebo; not to receive high-frequency chest wall oscillation (HFCWO)

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Taichung Veterans General Hospital
• Investigators: Principal Investigator: Chieh-Liang Wu, Ph.D., Taichung Veterans General Hospital

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Actual): December 1, 2012
• Study Completion (Actual): December 1, 2012

Study Registration Dates

• First Submitted: February 20, 2014
• First Submitted That Met QC Criteria: March 2, 2014
• First Posted (Estimate): March 4, 2014

Study Record Updates

• Last Update Posted (Estimate): March 4, 2014
• Last Update Submitted That Met QC Criteria: March 2, 2014
• Last Verified: March 1, 2014

More Information

Terms related to this study

• Keywords: mechanical ventilation; randomized controlled trial; elderly; effectiveness; pneumonia; high frequency chest wall oscillation
• Other Study ID Numbers: C10216; huang5598 (Other Identifier: Taichung VGH)