- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01354561
Respiratory Physical Therapy on the Cardiac Autonomic Modulation Paediatric Patients
Effect of Airway Clearance Therapy on the Cardiac Autonomic Modulation in Hospitalized Paediatric Patients
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The study of heart rate variability (HRV) is a method allowing non-invasive and selective evaluation of the changes in cardiac autonomic modulation. Its use in several clinical situations has provided important information, serving as an evaluation instrument for a better understanding of the involvement of the autonomic nervous system in various physiopathological situations.
With regard to the applicability of HRV analysis in paediatric populations, it is known that the maturity progression of sympathetic and vagal divisions is accompanied by a growing increase in autonomic modulation over the pre- and post-natal periods. In turn, a few studies have addressed the association between pathological paediatric conditions and changes in the cardiac autonomic modulation, consequently, HRV.
Among these pathologies, the respiratory affections are the main factors of morbidity and mortality in children, since newborns have peculiar aspects involving the respiratory system that can easily lead to a lung failure. Within this context, one can note the importance of the respiratory physiotherapy as an intervention using specific procedures in each case in order to decrease the airway resistance and improve the ventilation/perfusion ratio, thus improving the respiratory function and minimising the clinical severity. Consequently, in patients suffering from obstructive pathologies or neuromuscular dysfunctions, which makes cough an inefficient mechanism, physiotherapy can help them to recover from their condition.
Therefore, the respiratory physiotherapy has influence on the several hospitalisation phases, contributing to make the hospital stays shorter and less difficult to the paediatric inpatient and promoting a more humanised and more efficient environment based on the patient's needs. In this sense, it is possible that the paediatric inpatients present important alterations in their cardiovascular autonomic control, since constant oscillations in the cardiac and hemodynamic parameters are observed. However, studies correlating HRV with respiratory pathological conditions in paediatric inpatients are rare, either before or after the respiratory physiotherapy procedures, such as application of airway clearance techniques.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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São Paulo
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Ribeirão Preto, São Paulo, Brazil, 14049-900
- University of Sao Paulo
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- hospitalized children
Exclusion Criteria:
- age above 12 months;
- presence of cardiovascular disease or chronic respiratory disease;
- prescription of vasoactive drugs or sedatives;
- invasive mechanical ventilation;
- children on contact or respiratory isolation.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Sham Comparator: control group
Physiotherapy in the control group were also done at hospital, in dorsal decubitus position at 30-degree elevation, all receiving the same treatment given for the paediatric inpatients, except nasotracheal suction, which was not performed due to ethical reasons.
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Respiratory physical therapy using airway clearance techniques was conducted by a physiotherapist according to a detailed clinical evaluation of each patient, consisting of thoracic percussion, manual vibration, postural drainage, and cough stimulation.
Other Names:
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Active Comparator: respiratory disease group
Respiratory disease group consisting of hospitalized children with acute viral bronchiolitis
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Respiratory physical therapy using airway clearance techniques was conducted by a physiotherapist according to a detailed clinical evaluation of each patient, consisting of thoracic percussion, manual vibration, postural drainage, and cough stimulation.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Heart Rate Variability
Time Frame: basal record
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The heart rate (HR) was recorded with the children in the dorsal decubitus position at 30-degree elevation during 30 minutes before performing the respiratory physiotherapy using airway clearance techniques (ACTs)
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basal record
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Heart Rate Variability
Time Frame: 5 minutes after ACTs
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The heart rate (HR) was recorded with the children in the dorsal decubitus position at 30-degree elevation during 10 minutes after 5 minutes performing the respiratory physiotherapy using airway clearance techniques(ACTs)
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5 minutes after ACTs
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Heart Rate Variability
Time Frame: 5 minutes after nasotracheal suction
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The heart rate (HR) was recorded with the children in the dorsal decubitus position at 30-degree elevation after 5 minutes nasotracheal suction (10-minutes record).
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5 minutes after nasotracheal suction
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Heart Rate Variability
Time Frame: 40 minutes after nasotracheal suction
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The heart rate (HR) was recorded with the children in the dorsal decubitus position at 30-degree elevation during 40 minutes after nasotracheal suction (30-minute record).
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40 minutes after nasotracheal suction
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Hugo CD Souza, Ph.D., University of Sao Paulo
Publications and helpful links
General Publications
- Sant'Ana JE, Pereira MG, Dias da Silva VJ, Dambros C, Costa-Neto CM, Souza HC. Effect of the duration of daily aerobic physical training on cardiac autonomic adaptations. Auton Neurosci. 2011 Jan 20;159(1-2):32-7. doi: 10.1016/j.autneu.2010.07.006. Epub 2010 Aug 13.
- Jacinto CP, Gastaldi AC, Aguiar DY, Maida KD, Souza HC. Physical therapy for airway clearance improves cardiac autonomic modulation in children with acute bronchiolitis. Braz J Phys Ther. 2013 Nov-Dec;17(6):533-40. doi: 10.1590/S1413-35552012005000120. Epub 2013 Nov 1.
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- USP10
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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