Physiotherapy on Pneumonia in Childrens

NCT ID: NCT03343717

Last Updated: 2020-08-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-01
• Study Completion Date: 2020-07-01

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.

Conditions

Pneumonia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Rehabilitation

Intervention Type: OTHER

physical therapy exercise

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

Group Type: ACTIVE_COMPARATOR

Chest physical therapy

Intervention Type: OTHER

chest physical therapy exercise

Interventions

Rehabilitation

physical therapy exercise

Intervention Type: OTHER

Chest physical therapy

chest physical therapy exercise

Intervention Type: OTHER

Other Intervention Names

physical therapy

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

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 8 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universidade do Estado do Pará

OTHER

Sponsor Role: collaborator

Universidade Metodista de Piracicaba

OTHER

Sponsor Role: lead

Responsible Party

Rodrigo Santiago Barbosa Rocha, Phd

DOCTOR

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rodrigo S Rocha, Doctor

Role: PRINCIPAL_INVESTIGATOR

Universidade do Estado do Pará

Locations

Fundação Santa Casa de Misericórdia do Pará

Belém, Pará, Brazil

Countries

Brazil

References

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.

Reference Type: RESULT

PMID: 23507722 (View on PubMed)

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.

Reference Type: RESULT

PMID: 24777303 (View on PubMed)

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.

Reference Type: RESULT

PMID: 27918395 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 34873117 (View on PubMed)

Other Identifiers

2.084.580

Identifier Type: -

Identifier Source: org_study_id