Effects of Physiotherapy in Hemodynamics and Childrens Respiratory Mechanics

Children Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01747954
• Other study ID #: 11112PSC009
• Status: Terminated
• Phase: N/A
• First received: November 16, 2012
• Last updated: December 19, 2012
• Start date: March 2010
• Est. completion date: January 2012

Study information

• Verified date: November 2012
• Source: Federal University of Uberlandia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 12
• Est. completion date: January 2012
• Est. primary completion date: September 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 1 Month to 60 Months

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Children
• Pulmonary Valve Insufficiency
• Respiratory Insufficiency

Intervention

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of Uberlandia

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	comparing all variables between the two groups		one hundred twenty minutes	No