Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04331496
Other study ID # 8.0
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date April 4, 2020
Est. completion date June 2022

Study information

Verified date February 2022
Source Guadarrama Hospital
Contact Juan Nicolas Cuenca Zaldivar, Mr
Phone +34 639 96 29 35
Email nicolas.cuenca@salud.madrid.org
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Bronchiolitis (BQ) is an acute viral infection of the lower respiratory tract that affects the bronchioles of babies younger than 24 months of age. Respiratory physiotherapy (FTR) appears as a complementary treatment measure in clinical guidelines and consensus on the management of BQ. Nebulization with 3% hypertonic serum before the FTR session induces an osmotic flow of water in the mucus, which facilitates drainage and reduces edema in the submucosal tissue.


Description:

Once each patient legal guardians has signed the informed consent document and it has been verified that the inclusion criteria are met, participants 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 method of blinding in the allocation will be carried out by choosing envelopes sealed by an external investigator to the study. The contents of the envelopes will be randomized by computer using the numerical randomization sequence generated with R ver 5.3.1 (R Foundation for Statistical Computing, Institute for Statistics and Mathematics, Welthandelsplatz 1, 1020 Vienna, Austria) based on stratified sampling for homogeneity , in two groups: nebulization with 3% hypertonic solution (group A) and in the nebulization group with 0.9% saline solution (group B). None of the participants who make up both the control and intervention groups will be prohibited from regular pharmacological treatment as prescribed by their doctor, such as Ventolin. It will be collected in the investigator's notebook the medications that each patient has prescribed by their doctor. But applying a bronchodilator is not part of the protocol, because physiotherapists cannot prescribe or administer a drug. Before receiving the usual and standard manual techniques of respiratory physiotherapy, patients receive nebulization, group A with hypertonic serum 4 ml 3% and group B with a single-dose saline (0.9 NaCl) physiological serum 5 ml for 8 minutes, both with nebulizer Philips® vibrating mesh. The effects of both are similar in effects, in terms of secretions and their osmotic effects. The aim of this study is to evaluate if the type of serum affects the results of the manual physiotherapy that is later carried out on children, but there is no clinical problem for randomly giving one serum or another, as to what is the effect of the serum on itself. The intervention ends with a 20-minute session of Respiratory Physiotherapy based on slow expiratory flow: a passive technique of expiratory aid applied to the participants by means of slow thoracic-abdominal pressure that begins at the end of a spontaneous expiration and continues until the residual volume. The physiotherapist through assisted cough or stimulation of the trachea achieves expectoration of sputum. Care must be taken during the maneuvers to maintain a supine position of the patient in a 30-degree incline, to avoid episodes of gastroesophageal reflux and decrease the risk of vomiting. Both groups will receive 3 evaluations by an investigator who will be blinded on the treatment and the objectives. The evaluations will be carried out at the beginning of the session (T0), immediately after the nebulization (T30) and 10 minutes after the end of the 20-minute physical therapy intervention (T60). This same treatment and evaluation sequence will be carried out every month for 6 months. The main variables will classify the participants according to the initial clinical severity score proposed by Wang (WS), the Wood-Downes Scale modified by Ferres (WDF-S) and the Pulmonary Score (PS) in addition to the measurement of Sp2 and heart rate (FC) measured through a pulse oximeter (Radical Touchscreen from Massimo®, Masimo Corporation, Irvine, CA)


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date June 2022
Est. primary completion date June 2022
Accepts healthy volunteers No
Gender All
Age group 6 Months to 24 Months
Eligibility Inclusion Criteria: - Have a medical diagnosis of a recurrent wheezing. - Have the informed consent signed by the legal guardians of the kid. Exclusion Criteria: - Acute bronchitis with score> 9 according to the Wang and Pulmonary Score clinical scale. - Acute BQ with score> 8 on Ferres' modified Wood-Downes scale (WDF-S) - Parental refusal - Comorbidity as cardiac, neurological or traumatic pathology. - Congenital anomalies. - Chronic pulmonary pathology such as bronchodysplasia. - Severe obstruction with a punctuation >10 according ESBA and >7 according pulmonary score.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Hypertonic solution
Hypertonic serum 4 ml 3%, administered for 8 minutes in a Philips® vibrating mesh nebulizer plus 20 minute session of Respiratory Physiotherapy based on slow expiratory flow: passive technique of expiratory aid applied to the participant by means of a slow thoracic-abdominal pressure that begins at the end of a spontaneous expiration and continues until the residual volume. The physiotherapist through assisted cough or stimulation of the trachea achieves expectoration of sputum.
Physiological solution
Single-dose physiological saline serum (5 ml 0.9% NaCl), administered for 8 minutes in a Philips® vibrating mesh nebulizer plus 20 minute session of Respiratory Physiotherapy based on slow expiratory flow: passive technique of expiratory aid applied to the participant by means of a slow thoracic-abdominal pressure that begins at the end of a spontaneous expiration and continues until the residual volume. The physiotherapist through assisted cough or stimulation of the trachea achieves expectoration of sputum.

Locations

Country Name City State
Spain J.Nicolas Cuenca Zaldivar Guadarrama Madrid

Sponsors (2)

Lead Sponsor Collaborator
Guadarrama Hospital Fisiobronquial Clínicas

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Modified 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. 6 months
Secondary Pulmonary Score It is a scale that is used to assess the severity of asthmatic exacerbation in children. The clinical severity scoring system is made up of three items: FR (by age), wheezing, and use of accessory musculature (sternocleidomastoid). Each item is scored from 0 to 3, the values of each item are added and a total result is obtained that goes from 0 (without exacerbation or very slight) to 9 (severe exacerbation). 6 months
Secondary Wood-Downes scale modified by Ferres Is a quantitative cumulative scale designed to assess clinical severity in patients with BQ. The clinical severity scoring system consists of six items: wheezing, circulation, respiratory rate (RF), heart rate (HR), ventilation, and cyanosis. Each item is scored from 0 to 3, the values of each item are added together and a total result of (1-3) mild, (4-7) moderate and (> 8) severe is obtained, with 14 being the maximum score and 0 the minimum. A higher score indicates a worse condition. 6 months
Secondary Oxygen saturation Measured by a pulse oximeter (Radical 7 Touchscreen by Massimo®, Masimo Corporation, Irvine, CA). 6 months
Secondary Heart rate Measured by a pulse oximeter (Radical 7 Touchscreen by Massimo®, Masimo Corporation, Irvine, CA). 6 months
See also
  Status Clinical Trial Phase
Recruiting NCT04989114 - Nasal Bubble Continuous Positive Airway Pressure in Reducing Respiratory Distress in Children With Bronchiolitis N/A
Recruiting NCT06016244 - Safe, Effective and Cost-Effective Oxygen Saturation Targets for Children and Adolescents With Respiratory Distress: a Randomized Controlled Trial N/A
Not yet recruiting NCT05902702 - Isotonic Saline for Children With Bronchiolitis N/A
Recruiting NCT02366715 - Treatment Of Bronchiolitis With Heated Humidified High Flow Nasal Cannula - Prospective And Retrospective Research Phase 3
Terminated NCT02219334 - Comparing Nasal Suction Devices in Children With Bronchiolitis: A Pilot Study N/A
Recruiting NCT01944995 - Work of Breathing in Nasal CPAP Versus High Flow Nasal Prong in Infants With Severe Acute Bronchiolitis N/A
Terminated NCT02834819 - Nebulized 3% Hypertonic Saline vs. Standard of Care in Patients With Bronchiolitis N/A
Terminated NCT01757496 - Cough Assist in Bronchiolitis N/A
Not yet recruiting NCT01414322 - Documentation of Continuous Wheeze and Cough Dynamics in Pediatric ER SOB Patients N/A
Completed NCT00369759 - An Epidemiological Study to Evaluate the RSV-Associated Lower Respiratory Track in Infections in Infants N/A
Completed NCT00347880 - Atrial and Brain Natriuretic Peptides in Bronchiolitis Phase 1
Recruiting NCT05548036 - A Feasibility RCT of Aerobika Verses ACBT in People With COPD N/A
Active, not recruiting NCT04302207 - The ROUTT-B (Reduce Over-Utilized Tests and Treatments in Bronchiolitis) Study N/A
Completed NCT02858531 - Predictive Tracking of Patient Flow in the Emergency Services During the Virus Winter Epidemics
Withdrawn NCT05994183 - The Bronchiolitis in Hospitalized Infants Study Early Phase 1
Terminated NCT03614507 - Automation Oxygen Flow Titration in Spontaneously Breathing Infants N/A
Completed NCT02856165 - High-flow Nasal Oxygen Therapy in Hospitalized Infant With Moderate-to-severe Bronchiolitis N/A
Recruiting NCT05909566 - Respiratory Support and Treatment for Efficient and Cost-Effective Care N/A
Recruiting NCT04437641 - Impact of Pediatrician Intervention on the Smoking Habits of Parents of Sick Children
Not yet recruiting NCT06083077 - Chest and Abdominal Wall Strapping in Infant With Bronchiolitis N/A