Effects of Physiotherapy in Hemodynamics and Childrens Respiratory Mechanics

Respiratory Mechanics and Hemodynamics in Children With Respiratory Failure: Comparison of Two Techniques of Respiratory Physiotherapy

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

Study Overview

• Status: Terminated
• Conditions: Respiratory Insufficiency; Children
• Intervention / Treatment: Other: Thoracic vibrocompression; Other: Bag Squeezing

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 1 year (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: 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 Names: BS

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	one hundred twenty minutes

Secondary Outcome Measures

Outcome Measure	Time Frame
comparing all variables between the two groups	one hundred twenty minutes

Collaborators and Investigators

• Sponsor: Federal University of Uberlandia
• Investigators: Principal Investigator: Letícia Martins, Federal University of Uberlândia

Study record dates

Study Major Dates

• Study Start: March 1, 2010
• Primary Completion (Actual): September 1, 2011
• Study Completion (Actual): January 1, 2012

Study Registration Dates

• First Submitted: November 16, 2012
• First Submitted That Met QC Criteria: December 10, 2012
• First Posted (Estimate): December 12, 2012

Study Record Updates

• Last Update Posted (Estimate): December 21, 2012
• Last Update Submitted That Met QC Criteria: December 19, 2012
• Last Verified: November 1, 2012

More Information

Terms related to this study

• Keywords: Respiratory Insufficiency; Respiratory Mechanics; Physiotherapy Techniques
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Respiratory Insufficiency
• Other Study ID Numbers: 11112PSC009