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What is the Effective Pulmonary Physiotherapy Method in Critically Care Patients?

Primary Purpose

Atelectasis

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
routine pulmonary rehabilitation
chest wall vibration technique
Sponsored by
ILKE KUPELI
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Atelectasis focused on measuring Pulmonary Rehabilitation, Chest Physiotherapy, High Frequency Chest Wall Oscillation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • aged over 18 years
  • Patients with more than three days intubated, in critical care unit of Mengücekgazi Training and Research Hospital

Exclusion Criteria:

  • Patients with rib fracture
  • acute hemorrhage
  • unstable intracranial pressure
  • existence of chest drainage tube and those have history of spinal surgery,
  • skin infection in the back and chest area and subcutaneous emphysema

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    routine pulmonary rehabilitation

    chest wall vibration technique

    Arm Description

    routine pulmonary rehabilitation consisted of position giving technique

    chest wall vibration technique in addition to the routine pulmonary rehabilitation method for 72 hours.

    Outcomes

    Primary Outcome Measures

    change from baseline of Lung Collapse Index (LCI) values were recorded by listening both the lungs and scoring between 0 and 4 (0: normal expansion, 1: single lobe collapse, 2: 2 lobe collapse, 3: multiple lobe collapse) at six month

    Secondary Outcome Measures

    weight of the dry sputum after six month

    Full Information

    First Posted
    December 30, 2015
    Last Updated
    January 1, 2016
    Sponsor
    ILKE KUPELI
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02645695
    Brief Title
    What is the Effective Pulmonary Physiotherapy Method in Critically Care Patients?
    Official Title
    Can High Frequency Chest Wall Oscillation Accelerate the Discharged of Intubated Intensive Care Patients?
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    February 2014 (undefined)
    Primary Completion Date
    July 2014 (Actual)
    Study Completion Date
    August 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    ILKE KUPELI

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Effects of the high frequent chest wall oscillation technique applied on the patients who were intubated in intensive care unit were investigated. A total of 30 patients who were intubated and under the mechanical ventilator supplied, were included in the study. While the control group (n=15) received routine pulmonary rehabilitation technique, the study group (n=15) was administered high frequency chest wall oscillation for 72 hours as 4 times of 15-minute intervals, in addition to the pulmonary rehabilitation technique. Patients 'APACHE-II scores, dry sputum weight, Lung Collapse Index and blood gas values were measured at the hours 24th, 48th and 72nd, and endotracheal aspirate culture was studied at initial and 72nd. In addition, patient outcomes were evaluated at the end of the first week.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Atelectasis
    Keywords
    Pulmonary Rehabilitation, Chest Physiotherapy, High Frequency Chest Wall Oscillation

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    30 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    routine pulmonary rehabilitation
    Arm Type
    Active Comparator
    Arm Description
    routine pulmonary rehabilitation consisted of position giving technique
    Arm Title
    chest wall vibration technique
    Arm Type
    Active Comparator
    Arm Description
    chest wall vibration technique in addition to the routine pulmonary rehabilitation method for 72 hours.
    Intervention Type
    Device
    Intervention Name(s)
    routine pulmonary rehabilitation
    Intervention Description
    received routine pulmonary rehabilitation consisted of position giving technique (left lateral, supine, right lateral), chest wall percussion, postural drainage and airway aspiration at every 3 hours.
    Intervention Type
    Device
    Intervention Name(s)
    chest wall vibration technique
    Intervention Description
    administered chest wall vibration technique in addition to the routine pulmonary rehabilitation method for 72 hours. Chest vibration method was applied with 7-10 hz frequency given by a ped wrapped around the thorax and pulmonary rehabilitation with 3 mmHg pressure four times a day with 15-minute periods (TheVest® Model 205).
    Primary Outcome Measure Information:
    Title
    change from baseline of Lung Collapse Index (LCI) values were recorded by listening both the lungs and scoring between 0 and 4 (0: normal expansion, 1: single lobe collapse, 2: 2 lobe collapse, 3: multiple lobe collapse) at six month
    Time Frame
    six month
    Secondary Outcome Measure Information:
    Title
    weight of the dry sputum after six month
    Time Frame
    six month

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: aged over 18 years Patients with more than three days intubated, in critical care unit of Mengücekgazi Training and Research Hospital Exclusion Criteria: Patients with rib fracture acute hemorrhage unstable intracranial pressure existence of chest drainage tube and those have history of spinal surgery, skin infection in the back and chest area and subcutaneous emphysema

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    23455861
    Citation
    Esguerra-Gonzalez A, Ilagan-Honorio M, Fraschilla S, Kehoe P, Lee AJ, Marcarian T, Mayol-Ngo K, Miller PS, Onga J, Rodman B, Ross D, Sommer S, Takayanagi S, Toyama J, Villamor F, Weigt SS, Gawlinski A. CNE article: pain after lung transplant: high-frequency chest wall oscillation vs chest physiotherapy. Am J Crit Care. 2013 Mar;22(2):115-24. doi: 10.4037/ajcc2013869.
    Results Reference
    background
    PubMed Identifier
    9742334
    Citation
    Massard G, Wihlm JM. Postoperative atelectasis. Chest Surg Clin N Am. 1998 Aug;8(3):503-28, viii.
    Results Reference
    background
    PubMed Identifier
    19099160
    Citation
    Manzano RM, Carvalho CR, Saraiva-Romanholo BM, Vieira JE. Chest physiotherapy during immediate postoperative period among patients undergoing upper abdominal surgery: randomized clinical trial. Sao Paulo Med J. 2008 Sep;126(5):269-73. doi: 10.1590/s1516-31802008000500005.
    Results Reference
    background
    PubMed Identifier
    12122521
    Citation
    Ntoumenopoulos G, Presneill JJ, McElholum M, Cade JF. Chest physiotherapy for the prevention of ventilator-associated pneumonia. Intensive Care Med. 2002 Jul;28(7):850-6. doi: 10.1007/s00134-002-1342-2. Epub 2002 May 24.
    Results Reference
    result
    PubMed Identifier
    8650276
    Citation
    Ciesla ND. Chest physical therapy for patients in the intensive care unit. Phys Ther. 1996 Jun;76(6):609-25. doi: 10.1093/ptj/76.6.609.
    Results Reference
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    PubMed Identifier
    10893365
    Citation
    Oermann CM, Swank PR, Sockrider MM. Validation of an instrument measuring patient satisfaction with chest physiotherapy techniques in cystic fibrosis. Chest. 2000 Jul;118(1):92-7. doi: 10.1378/chest.118.1.92.
    Results Reference
    result
    PubMed Identifier
    15635998
    Citation
    Warwick WJ, Wielinski CL, Hansen LG. Comparison of expectorated sputum after manual chest physical therapy and high-frequency chest compression. Biomed Instrum Technol. 2004 Nov-Dec;38(6):470-5. doi: 10.2345/0899-8205(2004)38[470:COESAM]2.0.CO;2.
    Results Reference
    result
    PubMed Identifier
    8165037
    Citation
    Hansen LG, Warwick WJ, Hansen KL. Mucus transport mechanisms in relation to the effect of high frequency chest compression (HFCC) on mucus clearance. Pediatr Pulmonol. 1994 Feb;17(2):113-8. doi: 10.1002/ppul.1950170207.
    Results Reference
    result
    PubMed Identifier
    3988672
    Citation
    Gross D, Zidulka A, O'Brien C, Wight D, Fraser R, Rosenthal L, King M. Peripheral mucociliary clearance with high-frequency chest wall compression. J Appl Physiol (1985). 1985 Apr;58(4):1157-63. doi: 10.1152/jappl.1985.58.4.1157.
    Results Reference
    result
    PubMed Identifier
    9702607
    Citation
    Langenderfer B. Alternatives to percussion and postural drainage. A review of mucus clearance therapies: percussion and postural drainage, autogenic drainage, positive expiratory pressure, flutter valve, intrapulmonary percussive ventilation, and high-frequency chest compression with the ThAIRapy Vest. J Cardiopulm Rehabil. 1998 Jul-Aug;18(4):283-9. doi: 10.1097/00008483-199807000-00005.
    Results Reference
    result
    PubMed Identifier
    19541567
    Citation
    Chen YC, Wu LF, Mu PF, Lin LH, Chou SS, Shie HG. Using chest vibration nursing intervention to improve expectoration of airway secretions and prevent lung collapse in ventilated ICU patients: a randomized controlled trial. J Chin Med Assoc. 2009 Jun;72(6):316-22. doi: 10.1016/S1726-4901(09)70378-8.
    Results Reference
    result

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