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Completed

NCT Number: NCT03343717

Physiotherapy on Pneumonia in Childrens

The children's susceptibility to respiratory problems is due to their anatomical and physiological characteristics; therefore, children with more severe clinical conditions may undergo invasive mechanical ventilation (IMV). However, its prolonged use favors tracheal injury, barotrauma and / or volutrauma, decreased cardiac output and oxygen toxicity, and especially the accumulation of respiratory secretions due to ineffective cough due to non-closure of the glottis and damage in the transport of mucus by the presence of the tracheal tube. Thus, triggering the development of mechanical ventilation-associated pneumonia (VAP), which is defined as a pulmonary infection that arises 48 to 72 hours after endotracheal intubation and the institution of invasive mechanical ventilation. As a consequence, respiratory work is performed by IMV, reducing the work exerted by spontaneous ventilation, causing neuromuscular disorders after 5 to 7 days of IMV, changes in muscle mechanics, reducing the capacity of the diaphragm to generate force, thus contributing to changes in modulation autonomic heart rate, changes in muscular trophism, generating physical deconditioning due to weakness and, finally, an increase in the length of hospitalization and immobilism. From this perspective, early mobilization emerges as a rehabilitation mechanism to improve muscle strength and joint mobility, as well as to improve lung function and respiratory system performance, as well as improved autonomic heart rate modulation. It can facilitate the weaning of IMV, reducing hospitalization time and promoting quality of life after discharge.

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Key information

Age range

1 year–8 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fundação Santa Casa de Misericórdia do Pará

Belém, Pará, 66.050-380, Brazil

About this study

We will select 40 volunteers of both sexes and between the ages of 1 and 8 years, with clinical diagnosis of VAP hospitalized in an intensive care unit, which will be submitted, together with the hospital protocol, the protocol of early mobilization. For these patients will be performed physical therapy evaluation in the pre-protocol period, on the second and fourth day of application of the protocol and 1 week at the end of the proposed protocol. For statistical analysis will be compared the pre and post-treatment data found in the evaluations and tabulated in a Microsoft Excel worksheet. BioStat 5.2 software will be used to analyze the results, and the choice of tests for this will depend on the types of distributions found and the homogeneity of the variables.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patients on invasive or non-invasive mechanical ventilation for less than 96 hours
  • with pneumonia due to invasive mechanical ventilation,
  • aged between 1 year and 8 years

Exclusion criteria

  • Severe Respiratory Failure
  • active bleeding
  • acute cerebral disorder
  • presence of orthopedic contraindications (bone fractures, dislocations, subluxations, postoperative, unstable spine)
  • neurological impairment with minimal functionality
  • neuromuscular disease

Treatment and study plan

rehabilitation

Other

physical therapy exercise

Other names: physical therapy

Chest physical therapy

Other

chest physical therapy exercise

Primary outcomes

  1. Heart rate variability

    Time frame: 5 days

    Influence of exercise on cardiac autonomic modulation

Secondary outcomes

  1. Muscle force

    Time frame: 5 days

    Analysis by Medical Research Council Scale of muscle force. The scale is classified in five grades Grade 5: Muscle contracts normally against full resistance. Grade 4: Muscle strength is reduced but muscle contraction can still move joint against resistance.

    Grade 3: Muscle strength is further reduced such that the joint can be moved only against gravity with the examiner's resistance completely removed. As an example, the elbow can be moved from full extension to full flexion starting with the arm hanging down at the side.

    Grade 2: Muscle can move only if the resistance of gravity is removed. As an example, the elbow can be fully flexed only if the arm is maintained in a horizontal plane.

    Grade 1: Only a trace or flicker of movement is seen or felt in the muscle or fasciculations are observed in the muscle.

    Grade 0: No movement is observed.

Sponsors and collaborators

Lead sponsor

Universidade Metodista de Piracicaba

Other

Collaborators

  • Universidade do Estado do Pará

Registry information

Official study title

Effects of Early Mobilization in Children With Pneumonia

Acronym: VAP

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Nov 17, 2017
Registry last updated
Aug 13, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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