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Effects of Physiotherapy in Hemodynamics and Childrens Respiratory Mechanics

Primary Purpose

Respiratory Insufficiency, Children

Status
Terminated
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Bag Squeezing
Thoracic vibrocompression
Sponsored by
Federal University of Uberlandia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Respiratory Insufficiency focused on measuring Respiratory Insufficiency, Physiotherapy Techniques, Respiratory Mechanics

Eligibility Criteria

1 Month - 60 Months (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • children aged between one and 60 months
  • diagnosed with respiratory failure
  • undergoing mechanical ventilation

Exclusion Criteria:

  • had traumatic brain injury
  • severe thrombocytopenia (<20,000 pl/mm³)
  • hypovolemia and cyanogenic congenital heart defects
  • pneumothorax, hemothorax and/or pleural effusion without previous drainage

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Bag Squeezing

    Thoracic vibrocompression

    Arm Description

    20% increase in FiO2 Inflation pressure of 30 cm H2O + 10l O2/min 0.5 ml saline 0.9% 10 Manual Hyperinflation 10 vibrocompression Aspiration Tracheal

    20% increase in FiO2 0.5 ml saline 10 vibrocompression toracica on the right and left Aspiration Tracheal

    Outcomes

    Primary Outcome Measures

    Effects of Bag Squeezing and vibrocompression chest in hemodynamic, resistance and respiratory system compliance
    All variables were assessed prior to the proposed technique (pre-maneuver), immediately after the execution of the technique randomly chosen (post-maneuver), 30, 60 and 120 after the end of the technique randomly chosen. The mean of three readings was used as the representative value for each variable. All children were ventilated with the same mechanical Dixtal® DX3020 Brazil ventilator

    Secondary Outcome Measures

    comparing all variables between the two groups

    Full Information

    First Posted
    November 16, 2012
    Last Updated
    December 19, 2012
    Sponsor
    Federal University of Uberlandia
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01747954
    Brief Title
    Effects of Physiotherapy in Hemodynamics and Childrens Respiratory Mechanics
    Official Title
    Respiratory Mechanics and Hemodynamics in Children With Respiratory Failure: Comparison of Two Techniques of Respiratory Physiotherapy
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2012
    Overall Recruitment Status
    Terminated
    Why Stopped
    Terminated
    Study Start Date
    March 2010 (undefined)
    Primary Completion Date
    September 2011 (Actual)
    Study Completion Date
    January 2012 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Federal University of Uberlandia

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The hypothesis of this study is that respiratory physiotherapy can promote improvement in respiratory mechanics in children with respiratory failure and the bag squeezing maneuver is more effective in improving respiratory mechanics in childrens and does not alter the hemodynamic proved safe

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Respiratory Insufficiency, Children
    Keywords
    Respiratory Insufficiency, Physiotherapy Techniques, Respiratory Mechanics

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    Investigator
    Allocation
    Randomized
    Enrollment
    12 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Bag Squeezing
    Arm Type
    Experimental
    Arm Description
    20% increase in FiO2 Inflation pressure of 30 cm H2O + 10l O2/min 0.5 ml saline 0.9% 10 Manual Hyperinflation 10 vibrocompression Aspiration Tracheal
    Arm Title
    Thoracic vibrocompression
    Arm Type
    Active Comparator
    Arm Description
    20% increase in FiO2 0.5 ml saline 10 vibrocompression toracica on the right and left Aspiration Tracheal
    Intervention Type
    Other
    Intervention Name(s)
    Bag Squeezing
    Other Intervention Name(s)
    BS
    Intervention Description
    To perform the BS technique, we used a Protec® manual inflation bag with a flow of 10 L / min and 100% oxygen. A Commercial Medical® manometer was adapted between the orotracheal tube and the inflation bag to monitor the inflation pressure which was recommendedat 30 cmH2O for all children of the BS group. Initially we instilled at most 0.5 ml saline solution(SS) at 0.9% followed by 10 manual hyperinflation maneuvers interspersed with 10 vibrocompression maneuvers and as a last procedure, we performed an aspiration of the orotracheal tube airways and mouth. Between the aspirations the child was re-connected to the ventilator.
    Intervention Type
    Other
    Intervention Name(s)
    Thoracic vibrocompression
    Other Intervention Name(s)
    TVC
    Intervention Description
    To perform the TVC technique, we applied 10 vibrocompression maneuvers on the chest of the children during the expiratory phase of the respiratory cycle, on each of the lateral decubitus position, totaling 20 maneuvers, followed by aspiration in the dorsal decubitus position. All measurements in both study groups were performed with the child connected to the ventilator. Before starting the maneuver BS or TVC the child received an increase of 20% fraction of inspired oxygen (FiO2) from what was received previously in MV and after data collection FiO2 returned to baseline values.
    Primary Outcome Measure Information:
    Title
    Effects of Bag Squeezing and vibrocompression chest in hemodynamic, resistance and respiratory system compliance
    Description
    All variables were assessed prior to the proposed technique (pre-maneuver), immediately after the execution of the technique randomly chosen (post-maneuver), 30, 60 and 120 after the end of the technique randomly chosen. The mean of three readings was used as the representative value for each variable. All children were ventilated with the same mechanical Dixtal® DX3020 Brazil ventilator
    Time Frame
    one hundred twenty minutes
    Secondary Outcome Measure Information:
    Title
    comparing all variables between the two groups
    Time Frame
    one hundred twenty minutes

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    1 Month
    Maximum Age & Unit of Time
    60 Months
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: children aged between one and 60 months diagnosed with respiratory failure undergoing mechanical ventilation Exclusion Criteria: had traumatic brain injury severe thrombocytopenia (<20,000 pl/mm³) hypovolemia and cyanogenic congenital heart defects pneumothorax, hemothorax and/or pleural effusion without previous drainage
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Letícia Martins
    Organizational Affiliation
    Federal University of Uberlandia
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

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    Effects of Physiotherapy in Hemodynamics and Childrens Respiratory Mechanics

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