Respiratory Physical Therapy on the Cardiac Autonomic Modulation Paediatric Patients

May 13, 2011 updated by: University of Sao Paulo

Effect of Airway Clearance Therapy on the Cardiac Autonomic Modulation in Hospitalized Paediatric Patients

The present study investigated the influence of respiratory affections on the heart rate variability (HRV) of paediatric patients. We have hypothesised that respiratory physiotherapy would promote a beneficial effect on the cardiac autonomic modulation. Twenty-four children, who were divided into respiratory disease group (RG) and control (CG) groups, were studied. Analysis of HRV was performed with the RG in the dorsal decubitus position during four different moments: basal record (30 minutes); 5 minutes after respiratory physiotherapy by means of airway clearance techniques (10-minute record); 5 minutes after nasotracheal suction (10-minute record); and 40 minutes after nasotracheal suction (30-minute record). CG group was submitted to the same protocol, except nasotracheal suction, which was not performed due to ethical reasons.

Study Overview

Status

Completed

Conditions

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

Interventional

Enrollment (Actual)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • São Paulo
      • Ribeirão Preto, São Paulo, Brazil, 14049-900
        • University of Sao Paulo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 months to 11 months (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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.
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:
  • chest therapy
Active Comparator: respiratory disease group
Respiratory disease group consisting of hospitalized children with acute viral bronchiolitis
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:
  • chest therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Heart Rate Variability
Time Frame: basal record
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)
basal record

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Heart Rate Variability
Time Frame: 5 minutes after ACTs
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)
5 minutes after ACTs
Heart Rate Variability
Time Frame: 5 minutes after nasotracheal suction
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).
5 minutes after nasotracheal suction
Heart Rate Variability
Time Frame: 40 minutes after nasotracheal suction
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).
40 minutes after nasotracheal suction

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Hugo CD Souza, Ph.D., University of Sao Paulo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2007

Primary Completion (Actual)

May 1, 2009

Study Completion (Actual)

May 1, 2010

Study Registration Dates

First Submitted

May 9, 2011

First Submitted That Met QC Criteria

May 13, 2011

First Posted (Estimate)

May 17, 2011

Study Record Updates

Last Update Posted (Estimate)

May 17, 2011

Last Update Submitted That Met QC Criteria

May 13, 2011

Last Verified

May 1, 2011

More Information

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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