Physiotherapy on Pneumonia in Childrens

NCT03343717 | Completed DMC

• 1 other identifier: 2.084.580
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Pneumonia

Keywords

Pneumonia, Ventilator-Associated; Mechanical ventilation; Physical therapy

Outcome Measures

Primary Outcomes (1)

• Heart rate variability

  Influence of exercise on cardiac autonomic modulation

  5 days

Secondary Outcomes (1)

• Muscle force

  5 days

Study Arms (2)

rehabilitation

EXPERIMENTAL

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

chest physical therapy

ACTIVE COMPARATOR

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

Interventions

Rehabilitation OTHER

physical therapy exercise

Also known as: physical therapy

rehabilitation

Chest physical therapy OTHER

chest physical therapy exercise

chest physical therapy

Eligibility Criteria

• Age: 1 Year - 8 Years
• Gender Eligibility Details: 1 year to 8 years
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidade Metodista de Piracicaba: lead
• Universidade do Estado do Pará: collaborator

Study Sites (1)

Fundação Santa Casa de Misericórdia do Pará

Belém, Pará, 66.050-380, Brazil

Location

Related Publications (4)

• 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.

  PMID: 23507722 RESULT

• 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.

  PMID: 24777303 RESULT

• 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.

  PMID: 27918395 RESULT

• 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.

  PMID: 34873117 DERIVED

MeSH Terms

Conditions

Pneumonia; Pneumonia, Ventilator-Associated

Interventions

Rehabilitation; Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases; Healthcare-Associated Pneumonia; Cross Infection; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Rodrigo S Rocha, Doctor

  Universidade do Estado do Pará

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: DOCTOR

Model Details: randomized clinical trial

Study Record Dates

• First Submitted: November 12, 2017
• First Posted: November 17, 2017
• Study Start: January 1, 2017
• Primary Completion: July 1, 2020
• Study Completion: July 1, 2020
• Last Updated: August 13, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)