Effects of Physiotherapy in Hemodynamics and Childrens Respiratory Mechanics

NCT ID: NCT01747954

Last Updated: 2012-12-21

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-03-31
• Study Completion Date: 2012-01-31

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

Conditions

Respiratory Insufficiency; Children

Keywords

Respiratory Insufficiency; Physiotherapy Techniques; Respiratory Mechanics

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: EXPERIMENTAL

Thoracic vibrocompression

Intervention Type: OTHER

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.

Thoracic vibrocompression

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

Group Type: ACTIVE_COMPARATOR

Bag Squeezing

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

Other Intervention Names

BS; TVC

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

• Minimum Eligible Age: 1 Month
• Maximum Eligible Age: 60 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Federal University of Uberlandia

OTHER

Sponsor Role: lead

Responsible Party

Letícia de Queiroz Martins

specialist in child health - Clinical Hospital of the Federal University of Uberlândia

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Letícia Martins

Role: PRINCIPAL_INVESTIGATOR

Federal University of Uberlandia

Other Identifiers

11112PSC009

Identifier Type: -

Identifier Source: org_study_id