Clinical trial NCT03343717: Physiotherapy on Pneumonia in Childrens
Official title: Effects of Early Mobilization in Children With Pneumonia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pneumonia
Keywords: Pneumonia, Ventilator-Associated
Mechanical ventilation
Physical therapy
Lead sponsor: Universidade Metodista de Piracicaba
Sponsor class: OTHER
Collaborators: name: Universidade do Estado do Pará
First posted: 2017-11-17
Enrollment: 40
Sex: ALL
Minimum age (years): 1
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized clinical trial
Primary purpose: OTHER

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Heart rate variability
timeFrame: 5 days
Secondary outcomes:
measure: Muscle force
timeFrame: 5 days
Other outcomes:
Locations:
city: Belém
country: Brazil
facility: Fundação Santa Casa de Misericórdia do Pará
state: Pará
Study officials:
affiliation: Universidade do Estado do Pará
name: Rodrigo S Rocha, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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):e270-9. doi: 10.1097/PCC.0000000000000160.
citation: Choong K. Early Mobilization in Critically Ill Children: Ready for Implementation? Pediatr Crit Care Med. 2016 Dec;17(12):1194-1195. doi: 10.1097/PCC.0000000000000992. No abstract available.
citation: Souza GSB, Novais MFM, Lemes GE, de Mello MLFMF, de Sales SCD, Cunha KDC, Rocha LSO, Avila PES, Rocha RSB. Effectiveness of Different Physiotherapy Protocols in Children in the Intensive Care Unit: A Randomized Clinical Trial. Pediatr Phys Ther. 2022 Jan 1;34(1):10-15. doi: 10.1097/PEP.0000000000000848.