Saline vs Hypertonic Serum With Respiratory Physiotherapy in a Recurrent Wheezing Patient

Sponsor

Guadarrama Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT04331496

Collaborator

Fisiobronquial Clínicas (Other)

100

Enrollment

Location

Arms

25.9

Anticipated Duration (Months)

3.9

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Bronchiolitis	Other: Hypertonic solution Other: Physiological solution	N/A

Detailed 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)

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Single-blind randomized controlled trialSingle-blind randomized controlled trial

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Saline Serum Versus Hypertonic Serum With Respiratory Physiotherapy in a Recurrent Wheezing Patient: a Multicenter Clinical Trial

Actual Study Start Date :

Apr 4, 2020

Anticipated Primary Completion Date :

Jun 1, 2022

Anticipated Study Completion Date :

Jun 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Hypertonic solution Hypertonic solution 4 ml 3% , for 8 minutes in a Philips® vibrating mesh nebulizer plus 20 minute session of Respiratory Physiotherapy based on slow expiratory flow.	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.
Active Comparator: Physiological solution Single-dose physiological saline serum (5 ml 0.9% NaCl), for 8 minutes in a Philips® vibrating mesh nebulizer plus 20 minute session of Respiratory Physiotherapy based on slow expiratory flow.	Other: 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.

Arm

Intervention/Treatment

Experimental: Hypertonic solution

Hypertonic solution 4 ml 3% , for 8 minutes in a Philips® vibrating mesh nebulizer plus 20 minute session of Respiratory Physiotherapy based on slow expiratory flow.

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.

Active Comparator: Physiological solution

Single-dose physiological saline serum (5 ml 0.9% NaCl), for 8 minutes in a Philips® vibrating mesh nebulizer plus 20 minute session of Respiratory Physiotherapy based on slow expiratory flow.

Other: 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.

Outcome Measures

Primary Outcome Measures

Modified Wang clinical severity scale [6 months]
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

Pulmonary Score [6 months]
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).
Wood-Downes scale modified by Ferres [6 months]
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.
Oxygen saturation [6 months]
Measured by a pulse oximeter (Radical 7 Touchscreen by Massimo®, Masimo Corporation, Irvine, CA).
Heart rate [6 months]
Measured by a pulse oximeter (Radical 7 Touchscreen by Massimo®, Masimo Corporation, Irvine, CA).

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Months to 24 Months

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.