AzTrials
AzTrials

Acute Respiratory FailureHFCWOonAFRNCT02758106

HFCWO on Pneumonic Respiratory Failure

A study testing Vest Airway Clearance System Model 105 in people with Acute Respiratory Failure and Pneumonia, run by Chung Shan Medical University.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

BACKGROUND: Endotracheal intubation and prolonged immobilization of patients receiving mechanical ventilation may reduce expectoration function. High frequency chest wall oscillation (HFCWO) may ameliorate airway secretion movement; however, the vigorous oscillation may influence ventilator settings and change… Read more about this study

Who is it for?
Ages 20 to 85 years
Conditions the study is for
Acute Respiratory Failure, Pneumonia
What is being tested?
Vest Airway Clearance System Model 105
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
73 participants
Where
No sites listed yet
Study dates
Feb 2014to Nov 2015
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • acute pneumonic respiratory failure and received endotracheal intubation and mechanical ventilation,
  • having sufficient sputum production to require the physician to order airway secretion clearance

Who cannot join

  • pregnancy
  • pneumothorax
  • manifest hemoptysis
  • unstable hemodynamics
  • increased intracranial pressure
  • those undergoing major cardiac, thoracic or abdominal surgery

About this study

Official title: The Instantaneous Effects of High-Frequency Chest Wall Oscillation on Patients With Acute Pneumonic Respiratory Failure Receiving Mechanical Ventilation

BACKGROUND: Endotracheal intubation and prolonged immobilization of patients receiving mechanical ventilation may reduce expectoration function. High frequency chest wall oscillation (HFCWO) may ameliorate airway secretion movement; however, the vigorous oscillation may influence ventilator settings and change instantaneous cardiopulmonary responses. The aim of this study was to investigate these issues. METHODS: Seventy-three patients aged >20 years who were intubated with mechanical ventilation for pneumonic respiratory failure were recruited and randomly classified into two groups (HFCWO group, n=36; and control group who received conventional chest physical therapy (CCPT), n=37). HFCWO was applied with a fixed protocol, while CCPT was conducted using standard protocols. Both groups received sputum suction after the procedure. Changes in ventilator settings and the subjects' responses were measured at pre-set intervals and compared within groups and between groups.

Read the detailed description

Pneumonia may increase bronchial secretion and decrease mucociliary function, thereby causing lung atelectasis. Patients with acute pneumonic respiratory failure receiving mechanical ventilation may therefore have a large amount of pulmonary secretions, thereby worsening bronchial hygiene, oxyhemoglobin saturation and ventilation-perfusion match. Cough function is paramount for expectoration; however, coughing is not practical for patients with endotracheal intubation and sedation. High frequency chest wall oscillation (HFCWO) may dislodge airway secretions as efficiently as conventional chest physical therapy (CCPT). However, pneumonia is not currently an indication for chest physical therapy.

HFCWO compresses and relaxes the chest wall to generate an oscillated volume from the lungs, mimicking a "mini-cough" and producing shear stress at the air-mucus interface which changes the sputum rheology, thereby improving ventilation distribution, gas mixing, and forced expired volume in one second. Most studies that have reported no significant effects have focused on mortality, hospital stay, lung function or BODE (a multidimensional 10-point scale of body mass index, severity of airflow obstruction, dyspnea rated with the modified Medical Research Council, and exercise capacity evaluated with the Six-Minute Walk Distance) score. However, these outcome measurements are not associated with the immediate effects of chest physical therapy and may be affected by other factors such as disease severity.

Using the amount of sputum as the outcome measurement of HFCWO is not strongly recommended. However, immediate cardiopulmonary changes in HFCWO have not been studied in patients receiving mechanical ventilation, although this measurement is more explicit than lung function and BODE score, as they are impractical in these patients. Changes in ventilator settings caused by HFCWO are a concern when the patients receive both treatments simultaneously. The aim of this study was to investigate the effect of HFCWO on pneumonic subjects with acute respiratory failure receiving mechanical ventilation by evaluating immediate cardiopulmonary changes and changes in the initial ventilator settings.

Methods

The investigators conducted this comparative prospective randomized controlled single-blinded study at a university hospital. Adult subjects with pneumonia complicated with acute respiratory failure requiring endotracheal intubation and mechanical ventilation were consecutively recruited from a medical intensive care unit (ICU) (20-bed capacity). Pneumonia was defined as the presence of new or progressive pulmonary infiltrates and two of the following: body temperature > 38.3C or < 36C; white blood cell count > 12,000/mL or < 4,000/mL; purulent tracheal secretions without other signs of infection requiring antimicrobial treatment. Acute respiratory failure was defined as a sudden decrease in PaO2 < 60 mm Hg (or arterial oxyhemoglobin saturation < 90%) with or without PaCO2 > 45 mm Hg.17-19 All of the patients had sufficient sputum production to require the physician to order airway secretion clearance. Disease severity was assessed by Acute Physiology and Chronic Health Evaluation (APACHE) II score. Adverse events were evaluated by the investigators and reported to the institutional review board. The exclusion criteria were pregnancy, pneumothorax, manifest hemoptysis, unstable hemodynamics, increased intracranial pressure, and those undergoing major cardiac, thoracic or abdominal surgery.

All of the eligible patients had acute pneumonic respiratory failure and received endotracheal intubation and mechanical ventilation, and all signed informed consent forms. The patients were randomly allocated to the study group (HFCWO) or the control group (CCPT), as the efficacy of bronchial hygiene for both HFCWO and CCPT is comparable4. The primary investigators were blinded to which procedure the patients received. The local institutional review board of Chung Shan Medical University Hospital approved this study (No. CS13004). The experimental research was conducted in compliance with the Helsinki Declaration.

To prevent vomiting during or after chest care, all of the subjects underwent the procedure one hour before or two hours after feeding via a nasogastric tube. Inhalation therapy was performed with an aerosolized solution of 6 mL of half saline via the ventilator before HFCWO or CCPT.

HFCWO was performed using a VestTM Airway Clearance System Model 105 (Hill-Rom, St. Paul, Minnesota) connected to a vest via two flexible tubes by trained nurses who were blinded to the purpose of the study. All of the nurses had been well trained in how to perform both HFCWO and CCPT before the study, as these procedures are routinely performed by nurses at the investigators institution. HFCWO was applied to each subject at a frequency of 10-12 Hz and a pulse pressure setting of 1-2 selected from a scale ranging from 1 to 10 (arbitrary units) for 15 minutes. The patients receiving HFCWO were placed in a semi-upright sitting position, and the patients undergoing CCPT received cup-hand percussion with the hands positioned 3 inches from the chest, striking the chest with a waving movement while they were placed in right and left decubitus positions for 5-10 minutes each1. Following HFCWO or CCPT, suction was performed immediately via an endotracheal tube.

Changes to the initial ventilator settings during HFCWO were recorded by the trained nurses by checking the ventilator panel before and at 5, 10 and 15 minutes during HFCWO. The variables included peak airway pressure (Ppeak), positive-end expiratory pressure (PEEP), respiratory rate (RR), fraction of inspired oxygen (FIO2), inspiratory time, and sensitivity settings.

Changes in the patients' cardiopulmonary responses were measured before and at 5, 10 and 15 minutes during oscillation, and at 15 minutes after sputum suction. The measurement protocol for the CCPT group was the same as for the HFCWO group, except no measurements were taken at 5 or 10 minutes during percussion because it was not possible for a single nurse to perform percussion and record measurements at the same time.

Rapid shallow breathing index (RSBI) was calculated as follows:

RSBI = breathing frequency (breaths/minute)/tidal volume (liters) (1) Oxyhemoglobin saturation was measured using a pulse oximeter (SPO2). Data were presented as mean ± standard deviation (SD) or median (interquartile range). For each outcome variable, comparisons were planned a priori. A paired t or unpaired t test was used for within-group or between-group comparisons. For non-normal data, the Mann-Whitney test was used. The chi-square test or Fisher's exact test was used to compare proportions of categorical variables between the two groups. A p value less than 0.05 was considered to be statistically significant. All statistical analyses were performed using SAS software version 9.3 (SAS Institute Inc., Cary, NC) and Microcal Origin version 4.0 (Northampton, MA, USA).

Being tested
Vest Airway Clearance System Model 105, placebo intervention
Keywords
chest wall oscillation, acute respiratory failure, airway secretion
Medical subject headings
Pneumonia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Vest Airway Clearance System Model 105Device

    Also called HFCW oscillation, HFCWO

    HFCWO for 15 minutes then sputum suction.

  • placebo interventionDevice

    Also called CCPT, CC physical therapy

    CCPT for 15 minutes then sputum suction.

Study groups in NCT02758106
Study groupRoleWhat they receive
HFCW oscillationActive comparatorHFCWO was performed using a Vest Airway Clearance System Model 105 (Hill-Rom, St. Paul, Minnesota). HFCWO was applied to each subject at a frequency of 10-12 Hz and a pulse pressure setting of 1-2 selected for 15 minutes. The patients receiving HFCWO were placed in a semi-upright sitting position. Following HFCWO, suction was performed immediately via an endotracheal tube. Changes to the initial ventilator settings during HFCWO were recorded before and at 5, 10 and 15 minutes. The variables included peak airway pressure, positive-end expiratory pressure, respiratory rate, fraction of inspired oxygen, inspiratory time, and sensitivity settings. Following HFCWO, suction was performed immediately via an endotracheal tube.
Receives: Device: Vest Airway Clearance System Model 105
placebo interventionPlacebo comparatorthe patients undergoing CCPT received cup-hand percussion with the hands positioned 3 inches from the chest, striking the chest with a waving movement while they were placed in right and left decubitus positions for 5-10 minutes each. Following CCPT, suction was performed immediately via an endotracheal tube.
Receives: Device: placebo intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. peak airway pressure

    mm Hg

    Measured: 15 minutes

  2. mean airway pressure

    mm Hg

    Measured: 15 minutes

  3. minute ventilation

    liters per minute

    Measured: 15 minutes

  4. respiratory rate

    breaths per minute

    Measured: 15 minutes

  5. tidal volume

    miniliters

    Measured: 15 minutes

  6. rapid shallow breathing index

    breaths per minute/liter

    Measured: 15 minutes

  7. SpO2

    Measured: 15 minutes

Secondary outcomes (6)
  1. FiO2= inspired oxygen fraction

    Measured: 15 minutes

  2. respiratory rate

    times per minute

    Measured: 15 minutes

  3. airway pressure setting

    mm Hg

    Measured: 15 minutes

  4. inspiratory time

    second

    Measured: 15 minutes

  5. heart rate

    beat per minute

    Measured: 15 minutes

  6. blood pressures

    mm Hg

    Measured: 15 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 May 2016 (estimated)
  2. Study startFeb 2014
  3. Primary completionNov 2015
  4. Study completionNov 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
73 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02758106
Sponsor's protocol ID
CS13004
Acronym
HFCWOonAFR
Status last verified
Apr 2016
First submitted
24 Apr 2016
Last updated
2 May 2016
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • Allan JS, Garrity JM, Donahue DM. High-frequency chest-wall compression during the 48 hours following thoracic surgery. Respir Care. 2009 Mar;54(3):340-3.

    PubMed 19245727
  • Chaisson KM, Walsh S, Simmons Z, Vender RL. A clinical pilot study: high frequency chest wall oscillation airway clearance in patients with amyotrophic lateral sclerosis. Amyotroph Lateral Scler. 2006 Jun;7(2):107-11. doi: 10.1080/14660820600640570.

    PubMed 16753975
  • Clinkscale D, Spihlman K, Watts P, Rosenbluth D, Kollef MH. A randomized trial of conventional chest physical therapy versus high frequency chest wall compressions in intubated and non-intubated adults. Respir Care. 2012 Feb;57(2):221-8. doi: 10.4187/respcare.01299. Epub 2011 Jul 12.

    PubMed 21762564
  • Plioplys AV, Lewis S, Kasnicka I. Pulmonary vest therapy in pediatric long-term care. J Am Med Dir Assoc. 2002 Sep-Oct;3(5):318-21. doi: 10.1097/01.JAM.0000028225.84012.3B.

    PubMed 12807620
  • McCool FD, Rosen MJ. Nonpharmacologic airway clearance therapies: ACCP evidence-based clinical practice guidelines. Chest. 2006 Jan;129(1 Suppl):250S-259S. doi: 10.1378/chest.129.1_suppl.250S.

    PubMed 16428718
  • Whitman J, Van Beusekom R, Olson S, Worm M, Indihar F. Preliminary evaluation of high-frequency chest compression for secretion clearance in mechanically ventilated patients. Respir Care. 1993 Oct;38(10):1081-7.

    PubMed 10145892
  • Jones AP, Rowe BH. Bronchopulmonary hygiene physical therapy for chronic obstructive pulmonary disease and bronchiectasis. Cochrane Database Syst Rev. 2000;(2):CD000045. doi: 10.1002/14651858.CD000045.

    PubMed 10796474
  • Zahm JM, King M, Duvivier C, Pierrot D, Girod S, Puchelle E. Role of simulated repetitive coughing in mucus clearance. Eur Respir J. 1991 Mar;4(3):311-5.

    PubMed 1864345
  • Dosman CF, Jones RL. High-frequency chest compression: a summary of the literature. Can Respir J. 2005 Jan-Feb;12(1):37-41. doi: 10.1155/2005/525813.

    PubMed 15776126
  • Darbee JC, Kanga JF, Ohtake PJ. Physiologic evidence for high-frequency chest wall oscillation and positive expiratory pressure breathing in hospitalized subjects with cystic fibrosis. Phys Ther. 2005 Dec;85(12):1278-89.

    PubMed 16305267
  • Goktalay T, Akdemir SE, Alpaydin AO, Coskun AS, Celik P, Yorgancioglu A. Does high-frequency chest wall oscillation therapy have any impact on the infective exacerbations of chronic obstructive pulmonary disease? A randomized controlled single-blind study. Clin Rehabil. 2013 Aug;27(8):710-8. doi: 10.1177/0269215513478226. Epub 2013 Mar 15.

    PubMed 23503735
  • Park H, Park J, Woo SY, Yi YH, Kim K. Effect of high-frequency chest wall oscillation on pulmonary function after pulmonary lobectomy for non-small cell lung cancer. Crit Care Med. 2012 Sep;40(9):2583-9. doi: 10.1097/CCM.0b013e318258fd6d.

    PubMed 22732281
  • Chuang ML, Lee CY, Chen YF, Huang SF, Lin IF. Revisiting Unplanned Endotracheal Extubation and Disease Severity in Intensive Care Units. PLoS One. 2015 Oct 20;10(10):e0139864. doi: 10.1371/journal.pone.0139864. eCollection 2015.

    PubMed 26484674
  • King M, Phillips DM, Gross D, Vartian V, Chang HK, Zidulka A. Enhanced tracheal mucus clearance with high frequency chest wall compression. Am Rev Respir Dis. 1983 Sep;128(3):511-5. doi: 10.1164/arrd.1983.128.3.511.

    PubMed 6614645
  • Chatburn RL. High-frequency assisted airway clearance. Respir Care. 2007 Sep;52(9):1224-35; discussion 1235-7.

    PubMed 17716388

Questions about this trial

What is this clinical trial studying?

A study testing Vest Airway Clearance System Model 105 in people with Acute Respiratory Failure and Pneumonia, run by Chung Shan Medical University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 May 2016. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

peak airway pressure (time frame: 15 minutes). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02758106, which also lists 16 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2016.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in