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
About this trial
This is an interventional treatment trial for Respiratory Insufficiency focused on measuring Respiratory Insufficiency, Physiotherapy Techniques, Respiratory Mechanics
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
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
NCT ID
NCT01747954
First Posted
November 16, 2012
Last Updated
December 19, 2012
Sponsor
Federal University of Uberlandia
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
Learn more about this trial
Effects of Physiotherapy in Hemodynamics and Childrens Respiratory Mechanics
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