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Impact of Three Body Positioning Strategies in the Drainage Fluids After Coronary Artery Bypass Surgery (positioning)

Primary Purpose

Coronary Artery Disease

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Bed Rotation Group
Orthostatic Group
Sponsored by
University of Sao Paulo General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring mobility, coronary artery bypass, positioning, body

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • first postoperative day of cardiovascular surgery 6 hours after extubation
  • EFVE> 35%
  • writen inform consent

Exclusion Criteria:

  • neurological alteration
  • hemodynamics instability with PAM < 60 mmHg
  • blood
  • pneumothorax or broncopleural
  • arritymias

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    No Intervention

    Active Comparator

    Active Comparator

    Arm Label

    Control Group

    Bed Rotation Group

    Orthostatic Group

    Arm Description

    six hours after extubation receiving breathing exercises. After 48 hour postoperative time, sitting on armchair and keeping the erect position and walking in the same place.

    six hours after extubation receiving breathing exercises and submitted the continuous rotational bed therapy in the first postoperative day until 48 hours.

    six hours after extubation receiving breathing exercises and changing the body position following the sequence: sitting on the bed, sitting on the bed with the feet on the floor , standing and walking in the same place, in the first postoperative day until 48 hours.

    Outcomes

    Primary Outcome Measures

    volume of drainage fluids
    measure of volume of drainage fluids (mililiter) pre and post intervention until extract the mediastinal and/or thoracic tube

    Secondary Outcome Measures

    score of pulmonary complications
    incidence of postoperative pulmonary complications, was scored by a blinded independent investigator on an ordinal scale of 1 to 4

    Full Information

    First Posted
    July 20, 2015
    Last Updated
    August 13, 2015
    Sponsor
    University of Sao Paulo General Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02525289
    Brief Title
    Impact of Three Body Positioning Strategies in the Drainage Fluids After Coronary Artery Bypass Surgery
    Acronym
    positioning
    Official Title
    Study of Impact of Three Body Positioning Strategies in the Drainage Fluids in the Immediate Postoperative Period in Patients After Coronary Artery Bypass Surgery
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    November 2012 (undefined)
    Primary Completion Date
    December 2013 (Actual)
    Study Completion Date
    June 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Sao Paulo General Hospital

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    To investigate different strategies of body positioning associated to early corporal mobilization and verify the impact int the time and quantification of thoracic and mediastinal drainage, pulmonary complications and time of intensive care units in hospitals stay. After first six hours post extubation in the first postoperative day and after evaluation and inclusion in the study, patients were randomized in three groups for receiving different strategies of body positioning associated to early mobilization with help of bed Hill Rom (Hill Rom Batesville@): Group 1: Control (GC n=33); Group 2: Continuous Lateral Rotation Group (TRCL n=34); Group 3:Positioning in sitting and Orthostatic (ORT n=34).
    Detailed Description
    Coronary artery bypass surgery can lead to pulmonary complications like pleural effusion and pneumonia. These complications increase the length of stay and the immobility time. The investigators aim was to assess the impact of early mobilization of fluids drainage of chest tubes and the incidence of pulmonary complications. A prospective, randomized study included 101 patients divided in three groups. In the Control Group (CG:n=33) the patients were seated in armchair in the first 48 hours postoperative time. The Group (TRCL n=34) a Continuous Rotational Bed Therapy was instituted six hours post extubation in the first 24 hours and it comprised with by consecutive cycles of lateral rotation to the left and right side, and supine position with 30 seconds for pauses (using a Hill Rom Rotational Bed Device) witch stopped when need to perform routine measurements the hemodynamics measurements and clinical controls by nursing crew.The group ( ORT n=33) following the sequential steps T1: sitting in the bed for 2 hours, T2: sitting on the bed with their feet on the floor for 2 minutes and T3: the patients stoos up and walked on the spot for 2 minutes. Hemodynamics and oxygenation measurement before and after each intervention.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Coronary Artery Disease
    Keywords
    mobility, coronary artery bypass, positioning, body

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1
    Interventional Study Model
    Single Group Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    101 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Control Group
    Arm Type
    No Intervention
    Arm Description
    six hours after extubation receiving breathing exercises. After 48 hour postoperative time, sitting on armchair and keeping the erect position and walking in the same place.
    Arm Title
    Bed Rotation Group
    Arm Type
    Active Comparator
    Arm Description
    six hours after extubation receiving breathing exercises and submitted the continuous rotational bed therapy in the first postoperative day until 48 hours.
    Arm Title
    Orthostatic Group
    Arm Type
    Active Comparator
    Arm Description
    six hours after extubation receiving breathing exercises and changing the body position following the sequence: sitting on the bed, sitting on the bed with the feet on the floor , standing and walking in the same place, in the first postoperative day until 48 hours.
    Intervention Type
    Other
    Intervention Name(s)
    Bed Rotation Group
    Intervention Description
    Patients received continuous lateral rotation by a mechanical device (Hill Rom Bed Rotation), consecutive cycles of to left and right side, plus supine position during 30 seconds for pause, in the first postoperative day until 48 hours. Additional breathing exercises.
    Intervention Type
    Other
    Intervention Name(s)
    Orthostatic Group
    Intervention Description
    Patients were seated on the bed 6 hours post extubation for two hours. After, sitting in the bed with their feet on the floor for two minutes; standing up and walking in the place for two minutes, in the first 24 hours and 48 hours postoperative. Additional breathing exercises.
    Primary Outcome Measure Information:
    Title
    volume of drainage fluids
    Description
    measure of volume of drainage fluids (mililiter) pre and post intervention until extract the mediastinal and/or thoracic tube
    Time Frame
    48 hours
    Secondary Outcome Measure Information:
    Title
    score of pulmonary complications
    Description
    incidence of postoperative pulmonary complications, was scored by a blinded independent investigator on an ordinal scale of 1 to 4
    Time Frame
    7 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: first postoperative day of cardiovascular surgery 6 hours after extubation EFVE> 35% writen inform consent Exclusion Criteria: neurological alteration hemodynamics instability with PAM < 60 mmHg blood pneumothorax or broncopleural arritymias
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Filomena G Gallas, PHD
    Organizational Affiliation
    University of Sao Paulo
    Official's Role
    Study Director
    First Name & Middle Initial & Last Name & Degree
    Ludhmila A Hajjar, PHD
    Organizational Affiliation
    University of Sao Paulo Medical School
    Official's Role
    Study Chair
    First Name & Middle Initial & Last Name & Degree
    Maria Ignêz Z Feltrim, PHD
    Organizational Affiliation
    Heart Intsitute (InCor) Hospital das Clinicas - FMUSP
    Official's Role
    Study Director
    First Name & Middle Initial & Last Name & Degree
    Camila CM Buzzeto, PT
    Organizational Affiliation
    Heart Institute (InCor) Hospital das Clinicas - FMUSP
    Official's Role
    Study Chair
    First Name & Middle Initial & Last Name & Degree
    Vera RM Coimbra, PT
    Organizational Affiliation
    Heart Institute (InCor) Hospital das Clinicas _ FMUSP
    Official's Role
    Study Chair
    First Name & Middle Initial & Last Name & Degree
    Adriano RB Rodrigues, Nursing
    Organizational Affiliation
    Heart Intitute (InCor) Hospital das Clinicas _ FMUSP
    Official's Role
    Study Chair
    First Name & Middle Initial & Last Name & Degree
    Cristiane D Gonçalves, PT
    Organizational Affiliation
    Heart Intitute (InCor) Hospital das Clinicas _ FMUSP
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    16146459
    Citation
    Kirkeby-Garstad I, Stenseth R, Sellevold OF. Post-operative myocardial dysfunction does not affect the physiological response to early mobilization after coronary artery bypass grafting. Acta Anaesthesiol Scand. 2005 Oct;49(9):1241-7. doi: 10.1111/j.1399-6576.2005.00854.x.
    Results Reference
    result
    PubMed Identifier
    17192526
    Citation
    Goldhill DR, Imhoff M, McLean B, Waldmann C. Rotational bed therapy to prevent and treat respiratory complications: a review and meta-analysis. Am J Crit Care. 2007 Jan;16(1):50-61; quiz 62.
    Results Reference
    result
    PubMed Identifier
    17047215
    Citation
    Hulzebos EH, Helders PJ, Favie NJ, De Bie RA, Brutel de la Riviere A, Van Meeteren NL. Preoperative intensive inspiratory muscle training to prevent postoperative pulmonary complications in high-risk patients undergoing CABG surgery: a randomized clinical trial. JAMA. 2006 Oct 18;296(15):1851-7. doi: 10.1001/jama.296.15.1851.
    Results Reference
    result
    PubMed Identifier
    18596631
    Citation
    Morris PE, Goad A, Thompson C, Taylor K, Harry B, Passmore L, Ross A, Anderson L, Baker S, Sanchez M, Penley L, Howard A, Dixon L, Leach S, Small R, Hite RD, Haponik E. Early intensive care unit mobility therapy in the treatment of acute respiratory failure. Crit Care Med. 2008 Aug;36(8):2238-43. doi: 10.1097/CCM.0b013e318180b90e.
    Results Reference
    result
    PubMed Identifier
    19234100
    Citation
    Perme C, Chandrashekar R. Early mobility and walking program for patients in intensive care units: creating a standard of care. Am J Crit Care. 2009 May;18(3):212-21. doi: 10.4037/ajcc2009598. Epub 2009 Feb 20.
    Results Reference
    result
    PubMed Identifier
    12352030
    Citation
    Kirschenbaum L, Azzi E, Sfeir T, Tietjen P, Astiz M. Effect of continuous lateral rotational therapy on the prevalence of ventilator-associated pneumonia in patients requiring long-term ventilatory care. Crit Care Med. 2002 Sep;30(9):1983-6. doi: 10.1097/00003246-200209000-00006.
    Results Reference
    result
    PubMed Identifier
    6839822
    Citation
    Sonnenblick M, Melzer E, Rosin AJ. Body positional effect on gas exchange in unilateral pleural effusion. Chest. 1983 May;83(5):784-6. doi: 10.1378/chest.83.5.784.
    Results Reference
    result
    PubMed Identifier
    22414416
    Citation
    Sachdev G, Napolitano LM. Postoperative pulmonary complications: pneumonia and acute respiratory failure. Surg Clin North Am. 2012 Apr;92(2):321-44, ix. doi: 10.1016/j.suc.2012.01.013.
    Results Reference
    result
    PubMed Identifier
    22666720
    Citation
    Mirmohammad-Sadeghi M, Etesampour A, Gharipour M, Shariat Z, Nilforoush P, Saeidi M, Mackie M, Sadeghi FM. Early chest tube removal after coronary artery bypass graft surgery. N Am J Med Sci. 2009 Dec;1(7):333-7. doi: 10.4297/najms.2009.7333.
    Results Reference
    result
    PubMed Identifier
    15470853
    Citation
    Ahrens T, Kollef M, Stewart J, Shannon W. Effect of kinetic therapy on pulmonary complications. Am J Crit Care. 2004 Sep;13(5):376-83.
    Results Reference
    result
    PubMed Identifier
    22807649
    Citation
    Adler J, Malone D. Early mobilization in the intensive care unit: a systematic review. Cardiopulm Phys Ther J. 2012 Mar;23(1):5-13.
    Results Reference
    result
    PubMed Identifier
    14742360
    Citation
    Kirkeby-Garstad I, Sellevold OFM, Stenseth R, Skogvoll E, Karevold A. Marked mixed venous desaturation during early mobilization after aortic valve surgery. Anesth Analg. 2004 Feb;98(2):311-317. doi: 10.1213/01.ANE.0000096194.10459.7E.
    Results Reference
    result
    PubMed Identifier
    1580723
    Citation
    Kroenke K, Lawrence VA, Theroux JF, Tuley MR. Operative risk in patients with severe obstructive pulmonary disease. Arch Intern Med. 1992 May;152(5):967-71.
    Results Reference
    result

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    Impact of Three Body Positioning Strategies in the Drainage Fluids After Coronary Artery Bypass Surgery

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