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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
24

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Brazil
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Procedure: Respiratory physical therapy
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
Procedure: Respiratory physical therapy
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Sao Paulo

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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.

General Publications

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2007

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2009

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2010

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 9, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 13, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 17, 2011

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 17, 2011

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 13, 2011

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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