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)