Physiotherapy on Pneumonia in Childrens

Pneumonia Clinical Trial

— VAP  

Official title:

Effects of Early Mobilization in Children With Pneumonia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03343717
• Other study ID #: 2.084.580
• Status: Completed
• Phase: N/A
• Start date: January 1, 2017
• Est. completion date: July 1, 2020

Study information

• Verified date: August 2020
• Source: Universidade Metodista de Piracicaba
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: July 1, 2020
• Est. primary completion date: July 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 8 Years

Eligibility

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

Related Conditions & MeSH terms

• Pneumonia

Intervention

Other:
• Rehabilitation
physical therapy exercise
• Chest physical therapy
chest physical therapy exercise

Locations

Country	Name	City	State
Brazil	Fundação Santa Casa de Misericórdia do Pará	Belém	Pará

Sponsors (2)

Lead Sponsor	Collaborator
Universidade Metodista de Piracicaba	Universidade do Estado do Pará

Country where clinical trial is conducted

Brazil, 

References & Publications (3)

Choong K, Foster G, Fraser DD, Hutchison JS, Joffe AR, Jouvet PA, Menon K, Pullenayegum E, Ward RE; Canadian Critical Care Trials Group. Acute rehabilitation practices in critically ill children: a multicenter study. Pediatr Crit Care Med. 2014 Jul;15(6): — View Citation

Choong K, Koo KK, Clark H, Chu R, Thabane L, Burns KE, Cook DJ, Herridge MS, Meade MO. Early mobilization in critically ill children: a survey of Canadian practice. Crit Care Med. 2013 Jul;41(7):1745-53. doi: 10.1097/CCM.0b013e318287f592. — View Citation

Choong K. Early Mobilization in Critically Ill Children: Ready for Implementation? Pediatr Crit Care Med. 2016 Dec;17(12):1194-1195. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Heart rate variability	Influence of exercise on cardiac autonomic modulation	5 days
Secondary	Muscle force	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.	5 days