Saline vs Hypertonic Serum With Respiratory Physiotherapy in a Recurrent Wheezing Patient
Saline Serum Versus Hypertonic Serum With Respiratory Physiotherapy in a Recurrent Wheezing Patient: a Multicenter Clinical Trial
1 other identifier
interventional
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Apr 2020
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 31, 2020
CompletedFirst Posted
Study publicly available on registry
April 2, 2020
CompletedStudy Start
First participant enrolled
April 4, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2022
CompletedFebruary 18, 2022
February 1, 2022
2.2 years
March 31, 2020
February 17, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (4)
Pulmonary Score
6 months
Wood-Downes scale modified by Ferres
6 months
Oxygen saturation
6 months
Heart rate
6 months
Study Arms (2)
Hypertonic solution
EXPERIMENTALHypertonic 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.
Physiological solution
ACTIVE COMPARATORSingle-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.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- Have a medical diagnosis of a recurrent wheezing.
- Have the informed consent signed by the legal guardians of the kid.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Guadarrama Hospitallead
- Fisiobronquial Clínicascollaborator
Study Sites (1)
J.Nicolas Cuenca Zaldivar
Guadarrama, Madrid, 28440, Spain
Related Publications (1)
Gonzalez-Bellido V, Velaz-Baza V, Rama-Suarez N, Jimeno-Esteo C, Sirvent-Gomez J, Cuenca-Zaldivar JN, Mayorales-Lises S, Donadio MVF, Fernandez-Carnero S. Effects and safety of hypertonic saline combined with airway clearance in non-hospitalized children with recurrent wheezing. Hong Kong Physiother J. 2023 Dec;43(2):105-115. doi: 10.1142/S1013702523500105. Epub 2023 Apr 14.
PMID: 37583920DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Juan Nicolas Cuenca Zaldivar, Mr
Hospital Guadarrama, servicio de fisioterapia
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Rehabilitation Service Principal Investigator
Study Record Dates
First Submitted
March 31, 2020
First Posted
April 2, 2020
Study Start
April 4, 2020
Primary Completion
June 1, 2022
Study Completion
June 1, 2022
Last Updated
February 18, 2022
Record last verified: 2022-02