Skip to main content
OpenTrials
Completed

NCT Number: NCT02077738

HFCWO in Prolonged Mechanical Ventilation Patients

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Chronic Ventilator Dependency Infections Lung Diseases Pneumonia Respiratory Tract Diseases Respiratory Tract Infections

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Taichung Veterans General Hospital

Taichung, 40705, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • continuous intra-tracheal intubation and mechanical ventilator support for at least 21 days
  • age ≥20 year-old
  • having an acute or chronic pulmonary condition requiring secretion mobilization as judged by the physician
  • alert consciousness; completion of the Modified Borg Scale (MBS) and Hamilton Anxiety Scale (HAS)
  • scheduled extubation within 24 hours after enrollment
  • without any contraindication for HFCWO (i.e., recent spinal injuries which have not yet been stabilized and active hemorrhage with hemodynamic instability)

Exclusion criteria

  • those who had undergone tracheostomy

Treatment and study plan

HFCWO (Hill-Rom Vest™ Airway Clearance System)

Device

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

Primary outcomes

  1. Effectiveness as determined by weaning success rates

    Time frame: up to 5 days after extubation

    Successful weaning was defined as continuous liberation from mechanical ventilator support longer than 5 days.

  2. Effectiveness as determined by daily clearance volume of sputum

    Time frame: up to 5 days after extubation

    The daily clearance volume of sputum was determined by the numbers of sputum suction per day

  3. Effectiveness as determined by serial changes in sputum coloration

    Time frame: 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.

  4. Effectiveness as determined by chest X-ray improvement rates

    Time frame: 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 outcomes

  1. safety as determined by the changes of blood pressures before and after HFCWO

    Time frame: 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.

  2. safety as determined by the changes of heart rates before and after HFCWO

    Time frame: 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.

  3. safety as determined by the changes of respiratory rates (RR) before and after HFCWO

    Time frame: 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.

  4. safety as determined by the changes of oxyhemoglobin saturations by pulse oximetry (SpO2) before and after HFCWO

    Time frame: 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.

  5. tolerance/comfort as determined by Modified Borg Scale (MBS)

    Time frame: 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.

  6. tolerance/comfort as determined by Hamilton Anxiety Scale (HAS)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Taichung Veterans General Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Mar 4, 2014
Registry last updated
Mar 4, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.