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Treatment of Pediatric Bronchiolitis

Primary Purpose

Bronchiolitis

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
High frequency compression of the chest wall group
Manual maneuvers physiotherapy group
Sponsored by
Guadarrama Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bronchiolitis focused on measuring Physical Therapy, Respiratory, Pediatric

Eligibility Criteria

2 Months - 12 Months (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patients must meet the following inclusion criteria:

  • Have an age between 2 months and 12 months.
  • Have a medical diagnosis of the first episode of BQ.
  • Have the informed consent signed by the child's legal guardians.

Exclusion Criteria:

The criteria of exclusion are:

  • BQ in acute phase with score> 9 according to Wang clinical scale.
  • Associated cardiac, neurological or traumatic pathology.
  • Previous hospitalization for wheezing.
  • Medical diagnosis of recurrent sibilant.

Sites / Locations

  • J.Nicolas Cuenca Zaldivar

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Manual maneuvers physiotherapy

High frequency compression chest wall

Arm Description

The protocol of physiotherapy treatment techniques consists of 20 minutes of FR based on prolonged slow expiration and cough provoked.

The protocol consists in the application of the Smart Vest® device for high frequency compression of the chest wall, with a fixed frequency of 13 Hz and a time of 15 minutes. Then during 20 minutes will apply the same protocol as in the manual maneuvers group.

Outcomes

Primary Outcome Measures

Wang clinical severity scale
The clinical severity scale of Wang evaluates the respiratory rate, the presence of wheezing and intercostal retraction, and the patient's general condition, puncturing each dimension from 0 (the possible state) to 3 (values within normal), in addition to offer different cut points for children with more or less than 6 months.

Secondary Outcome Measures

Oxygen saturation
Measured by a pulse oximeter (Radical 7 Touchscreen by Massimo®, Masimo Corporation, Irvine, CA).
Heart rate
Measured by a pulse oximeter (Radical 7 Touchscreen by Massimo®, Masimo Corporation, Irvine, CA).
Amount of sputum
The measurement of the amount of sputum collected in a metric measuring cup, once the session is finished, will be done in a calibrated weight

Full Information

First Posted
February 7, 2019
Last Updated
June 9, 2020
Sponsor
Guadarrama Hospital
Collaborators
Fisiobronquial Clínicas
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1. Study Identification

Unique Protocol Identification Number
NCT03835936
Brief Title
Treatment of Pediatric Bronchiolitis
Official Title
Immediate Effects and Safety of High-frequency Chest Wall Oscillation Compared to Airway Clearance Techniques in Non-hospitalized Infants With Acute Viral Bronchiolitis
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
March 1, 2019 (Actual)
Primary Completion Date
May 10, 2019 (Actual)
Study Completion Date
May 10, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Guadarrama Hospital
Collaborators
Fisiobronquial Clínicas

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Bronchiolitis (BQ) is the acute viral infection of the tract respiratory syndrome in infants that affects the bronchioles of babies under 24 months of age. Respiratory physiotherapy (RF) appears as a treatment measure complementary in the clinical guidelines and consensus on the management of the BQ.
Detailed Description
Once each patient legal guardians has signed the informed consent document and it has been verified that the inclusion criteria are met, it will be assigned the same identification number (ID) that is related to its Clinical History (CH) by simple coding; custody of the file with the relationship of each ID with its CH will be the responsibility of the principal investigator. The assignment will be made at the time of query according to a table of random numbers previously established and that it will only be known by physiotherapists. Before starting the treatment protocol, a blind evaluator who does not know the treatment to which the patient is assigned, classifies the child according to the initial score of clinical severity proposed by Wang, in addition to the measurement of SO2 and frequency heart rate through a pulse oximeter. The measurement of the amount of sputum collected in a meter measuring cup, once the respiratory physiotherapy session is finished, it will be done in a calibrated weight in both groups. The protocol in the manual maneuvers group consists of 20 minutes of FR based on prolonged slow expiration and coughing provoked. Is apassive technique of expiratory help applied to the baby through a slow thoracic-abdominal pressure that begins at the end of spontaneous expiration and continues to the residual volume. The physiotherapist through the cough provoked or stimulation of the trachea gets expectoration of sputum, to be able to assess its weight. The protocol in the high frequency compression chest wall group consists of the same protocol as the respiratory physiotherapy Group plus high frequency compression chest wall applied with Smart Vest® device, with a fixed frequency of 13 Hz and a time 15 min. The selected mode will be the normal (fixed parameters) and the pressure of 4 units (12 cm H2O). The patient remains seated on his parents, and with a cotton garment between the vest and the skin of the patient to prevent skin lesions. Attention must be paid during maneuvers to maintain a position of infant in supine decubitus in 30 degrees of slope, to avoid episodes of gastroesophageal reflux and decrease the risk of vomiting. Criteria for cessation of physiotherapeutic intervention, alterations will be considered abrupt of the respiratory rhythm (brady or tachypnea), stare, ocular revulsion, hiccups or hypertonia and changes in skin color (pallor or cyanosis). In addition to these manifestations clinics, it is established that if the parent or legal guardian so requires, the the application of the protocol. After 10 and 20 minutes of finishing both groups, the doctor again makes a measurement of mucus volume, SO2, heart and respiratory rate, and classify again according to the criteria of Wang's clinical severity scale.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bronchiolitis
Keywords
Physical Therapy, Respiratory, Pediatric

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Single-blind controlled clinical trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Manual maneuvers physiotherapy
Arm Type
Active Comparator
Arm Description
The protocol of physiotherapy treatment techniques consists of 20 minutes of FR based on prolonged slow expiration and cough provoked.
Arm Title
High frequency compression chest wall
Arm Type
Experimental
Arm Description
The protocol consists in the application of the Smart Vest® device for high frequency compression of the chest wall, with a fixed frequency of 13 Hz and a time of 15 minutes. Then during 20 minutes will apply the same protocol as in the manual maneuvers group.
Intervention Type
Other
Intervention Name(s)
High frequency compression of the chest wall group
Intervention Description
The protocol in the high frequency compression of the chest wall group device consists of the Smart Vest® application, with a fixed frequency of 13 Hz and a time of 15 minutes. The selected mode will be the normal (fixed parameters) and the pressure of 4 units (12 cm H2O). The patient remains seated on his parents, and with a cotton garment between the vest and the skin of the patient to prevent skin lesions.
Intervention Type
Other
Intervention Name(s)
Manual maneuvers physiotherapy group
Intervention Description
20 minutes of manual maneuvers physiotherapy based on prolonged slow expiration: passive technique of expiratory help applied to the baby through a slow thoracic-abdominal pressure that begins at the end of spontaneous expiration and continues to the residual volume. The physiotherapist through the cough provoked or stimulation of the trachea gets expectoration of sputum, to be able to assess its weight.
Primary Outcome Measure Information:
Title
Wang clinical severity scale
Description
The clinical severity scale of Wang evaluates the respiratory rate, the presence of wheezing and intercostal retraction, and the patient's general condition, puncturing each dimension from 0 (the possible state) to 3 (values within normal), in addition to offer different cut points for children with more or less than 6 months.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Oxygen saturation
Description
Measured by a pulse oximeter (Radical 7 Touchscreen by Massimo®, Masimo Corporation, Irvine, CA).
Time Frame
12 weeks
Title
Heart rate
Description
Measured by a pulse oximeter (Radical 7 Touchscreen by Massimo®, Masimo Corporation, Irvine, CA).
Time Frame
12 weeks
Title
Amount of sputum
Description
The measurement of the amount of sputum collected in a metric measuring cup, once the session is finished, will be done in a calibrated weight
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Months
Maximum Age & Unit of Time
12 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients must meet the following inclusion criteria: Have an age between 2 months and 12 months. Have a medical diagnosis of the first episode of BQ. Have the informed consent signed by the child's legal guardians. Exclusion Criteria: The criteria of exclusion are: BQ in acute phase with score> 9 according to Wang clinical scale. Associated cardiac, neurological or traumatic pathology. Previous hospitalization for wheezing. Medical diagnosis of recurrent sibilant.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
J. Nicolas Cuenca Zaldivar
Organizational Affiliation
Guadarrama Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
J.Nicolas Cuenca Zaldivar
City
Guadarrama
State/Province
Madrid
ZIP/Postal Code
28440
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
33144386
Citation
Gonzalez-Bellido V, Velaz-Baza V, Blanco-Moncada E, Del Carmen Jimeno Esteo M, Cuenca-Zaldivar JN, Colombo-Marro A, Donadio MVF, Torres-Castro R. Immediate Effects and Safety of High-Frequency Chest Wall Compression Compared to Airway Clearance Techniques in Non-Hospitalized Infants With Acute Viral Bronchiolitis. Respir Care. 2021 Mar;66(3):425-433. doi: 10.4187/respcare.08177. Epub 2020 Nov 3.
Results Reference
derived

Learn more about this trial

Treatment of Pediatric Bronchiolitis

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