VAP: Physiotherapy on Pneumonia in Childrens

Sponsor
Universidade Metodista de Piracicaba (Other)
Overall Status
Completed
CT.gov ID
NCT03343717
Collaborator
Universidade do Estado do Pará (Other)
40
1
2
42
1

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Rehabilitation
  • Other: Chest physical therapy
N/A

Detailed Description

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
randomized clinical trialrandomized clinical trial
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Other
Official Title:
Effects of Early Mobilization in Children With Pneumonia
Actual Study Start Date :
Jan 1, 2017
Actual Primary Completion Date :
Jul 1, 2020
Actual Study Completion Date :
Jul 1, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: rehabilitation

Phase 1 passive mobilization with 10 repetitions on each joint motion and muscle stretching to the upper. Phase 2 - ability to respond to 3 of 5 simple verbal commands. Beginning with passive, active-assisted or active exercises with 5 repetitions in each joint movement in the MMSS and MMII, following the sequence of phase 1. Phase 3 - exercises of MMSS with cycle ergometer - 1 series of 1 minute or passive, active-assisted, active or active-resistidos with 5 repetitions in each joint movement, following the sequence of phase 1.

Other: Rehabilitation
physical therapy exercise
Other Names:
  • physical therapy
  • Active Comparator: chest physical therapy

    respiratory exercises that include techniques of bronchial hygiene maneuvers with the objective of airway clearance, pulmonary reexpansion techniques for reversal of atelectasis, passive mobilization techniques with the aim of reducing deformities and preserving joint mobility

    Other: Chest physical therapy
    chest physical therapy exercise

    Outcome Measures

    Primary Outcome Measures

    1. Heart rate variability [5 days]

      Influence of exercise on cardiac autonomic modulation

    Secondary Outcome Measures

    1. Muscle force [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    1 Year to 8 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Fundação Santa Casa de Misericórdia do Pará Belém Pará Brazil 66.050-380

    Sponsors and Collaborators

    • Universidade Metodista de Piracicaba
    • Universidade do Estado do Pará

    Investigators

    • Principal Investigator: Rodrigo S Rocha, Doctor, Universidade do Estado do Pará

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Rodrigo Santiago Barbosa Rocha, Phd, DOCTOR, Universidade Metodista de Piracicaba
    ClinicalTrials.gov Identifier:
    NCT03343717
    Other Study ID Numbers:
    • 2.084.580
    First Posted:
    Nov 17, 2017
    Last Update Posted:
    Aug 13, 2020
    Last Verified:
    Aug 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Rodrigo Santiago Barbosa Rocha, Phd, DOCTOR, Universidade Metodista de Piracicaba
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 13, 2020