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Effects of Physiotherapy in Hemodynamics and Childrens Respiratory Mechanics

This study has been terminated.
(Terminated)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01747954
First Posted: December 12, 2012
Last Update Posted: December 21, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Letícia de Queiroz Martins, Federal University of Uberlandia
  Purpose
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

Condition Intervention
Respiratory Insufficiency Children Other: Bag Squeezing Other: Thoracic vibrocompression

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Respiratory Mechanics and Hemodynamics in Children With Respiratory Failure: Comparison of Two Techniques of Respiratory Physiotherapy

Resource links provided by NLM:


Further study details as provided by Letícia de Queiroz Martins, Federal University of Uberlandia:

Primary Outcome Measures:
  • Effects of Bag Squeezing and vibrocompression chest in hemodynamic, resistance and respiratory system compliance [ Time Frame: one hundred twenty minutes ]
    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 [ Time Frame: one hundred twenty minutes ]

Enrollment: 12
Study Start Date: March 2010
Study Completion Date: January 2012
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Bag Squeezing
  • 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
Other: Thoracic vibrocompression
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.
Other Name: TVC
Active Comparator: Thoracic vibrocompression
  • 20% increase in FiO2
  • 0.5 ml saline
  • 10 vibrocompression toracica on the right and left
  • Aspiration Tracheal
Other: Bag Squeezing
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.
Other Name: BS

  Eligibility

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Ages Eligible for Study:   1 Month to 60 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01747954


Sponsors and Collaborators
Federal University of Uberlandia
Investigators
Principal Investigator: Letícia Martins Federal University of Uberlandia
  More Information

Responsible Party: Letícia de Queiroz Martins, specialist in child health - Clinical Hospital of the Federal University of Uberlândia, Federal University of Uberlandia
ClinicalTrials.gov Identifier: NCT01747954     History of Changes
Other Study ID Numbers: 11112PSC009
First Submitted: November 16, 2012
First Posted: December 12, 2012
Last Update Posted: December 21, 2012
Last Verified: November 2012

Keywords provided by Letícia de Queiroz Martins, Federal University of Uberlandia:
Respiratory Insufficiency
Physiotherapy Techniques
Respiratory Mechanics

Additional relevant MeSH terms:
Respiratory Insufficiency
Pulmonary Valve Insufficiency
Respiration Disorders
Respiratory Tract Diseases
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases