search
Back to results

HFCWO on Pneumonic Respiratory Failure (HFCWOonAFR)

Primary Purpose

Acute Respiratory Failure, Pneumonia

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Vest Airway Clearance System Model 105
placebo intervention
Sponsored by
Chung Shan Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Acute Respiratory Failure focused on measuring chest wall oscillation, acute respiratory failure, airway secretion

Eligibility Criteria

20 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Placebo Comparator

    Arm Label

    HFCW oscillation

    placebo intervention

    Arm Description

    HFCWO 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.

    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 each. Following CCPT, suction was performed immediately via an endotracheal tube.

    Outcomes

    Primary Outcome Measures

    peak airway pressure
    mm Hg
    mean airway pressure
    mm Hg
    minute ventilation
    liters per minute
    respiratory rate
    breaths per minute
    tidal volume
    miniliters
    rapid shallow breathing index
    breaths per minute/liter
    SpO2

    Secondary Outcome Measures

    FiO2= inspired oxygen fraction
    respiratory rate
    times per minute
    airway pressure setting
    mm Hg
    inspiratory time
    second
    heart rate
    beat per minute
    blood pressures
    mm Hg

    Full Information

    First Posted
    April 24, 2016
    Last Updated
    April 29, 2016
    Sponsor
    Chung Shan Medical University
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT02758106
    Brief Title
    HFCWO on Pneumonic Respiratory Failure
    Acronym
    HFCWOonAFR
    Official Title
    The Instantaneous Effects of High-Frequency Chest Wall Oscillation on Patients With Acute Pneumonic Respiratory Failure Receiving Mechanical Ventilation
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    February 2014 (undefined)
    Primary Completion Date
    November 2015 (Actual)
    Study Completion Date
    November 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Chung Shan Medical University

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief 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 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.
    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).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Acute Respiratory Failure, Pneumonia
    Keywords
    chest wall oscillation, acute respiratory failure, airway secretion

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    73 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    HFCW oscillation
    Arm Type
    Active Comparator
    Arm Description
    HFCWO 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.
    Arm Title
    placebo intervention
    Arm Type
    Placebo Comparator
    Arm Description
    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 each. Following CCPT, suction was performed immediately via an endotracheal tube.
    Intervention Type
    Device
    Intervention Name(s)
    Vest Airway Clearance System Model 105
    Other Intervention Name(s)
    HFCW oscillation, HFCWO
    Intervention Description
    HFCWO for 15 minutes then sputum suction.
    Intervention Type
    Device
    Intervention Name(s)
    placebo intervention
    Other Intervention Name(s)
    CCPT, CC physical therapy
    Intervention Description
    CCPT for 15 minutes then sputum suction.
    Primary Outcome Measure Information:
    Title
    peak airway pressure
    Description
    mm Hg
    Time Frame
    15 minutes
    Title
    mean airway pressure
    Description
    mm Hg
    Time Frame
    15 minutes
    Title
    minute ventilation
    Description
    liters per minute
    Time Frame
    15 minutes
    Title
    respiratory rate
    Description
    breaths per minute
    Time Frame
    15 minutes
    Title
    tidal volume
    Description
    miniliters
    Time Frame
    15 minutes
    Title
    rapid shallow breathing index
    Description
    breaths per minute/liter
    Time Frame
    15 minutes
    Title
    SpO2
    Time Frame
    15 minutes
    Secondary Outcome Measure Information:
    Title
    FiO2= inspired oxygen fraction
    Time Frame
    15 minutes
    Title
    respiratory rate
    Description
    times per minute
    Time Frame
    15 minutes
    Title
    airway pressure setting
    Description
    mm Hg
    Time Frame
    15 minutes
    Title
    inspiratory time
    Description
    second
    Time Frame
    15 minutes
    Title
    heart rate
    Description
    beat per minute
    Time Frame
    15 minutes
    Title
    blood pressures
    Description
    mm Hg
    Time Frame
    15 minutes

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    85 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: acute pneumonic respiratory failure and received endotracheal intubation and mechanical ventilation, having sufficient sputum production to require the physician to order airway secretion clearance Exclusion Criteria: pregnancy pneumothorax manifest hemoptysis unstable hemodynamics increased intracranial pressure those undergoing major cardiac, thoracic or abdominal surgery
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Ming-Lung Chuang
    Organizational Affiliation
    Chung Shan Medical University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    19245727
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    16753975
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    21762564
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    12807620
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    16428718
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    10145892
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    10796474
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    1864345
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    15776126
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    16305267
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    23503735
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    22732281
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    26484674
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    6614645
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    17716388
    Citation
    Chatburn RL. High-frequency assisted airway clearance. Respir Care. 2007 Sep;52(9):1224-35; discussion 1235-7.
    Results Reference
    background
    PubMed Identifier
    28248854
    Citation
    Chuang ML, Chou YL, Lee CY, Huang SF. Instantaneous responses to high-frequency chest wall oscillation in patients with acute pneumonic respiratory failure receiving mechanical ventilation: A randomized controlled study. Medicine (Baltimore). 2017 Mar;96(9):e5912. doi: 10.1097/MD.0000000000005912.
    Results Reference
    derived

    Learn more about this trial

    HFCWO on Pneumonic Respiratory Failure

    We'll reach out to this number within 24 hrs