Nebulization of hypertonic saline
Otherapplication of hypertonic saline serum through a mask fogging or a box fogging
NCT Number: NCT02458300
The objective of this study is to evaluate the clinical response of children diagnosed with acute bronchiolitis, relative to a chest physiotherapy protocol. Comparing this treatment with standard care of the nursing staff and auxiliaries of infants patients aged 1 month to 2 years.
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Notify Me1 month–2 year
All sexes
Interventional
Not applicable
This randomized clinical trial has an intervention group and a control group. All treatment will be made by physiotherapist with extensive clinical experience and training in techniques of Chest physiotherapy (CPT). Performing at least one session per day during the time of patient admission. This session takes an average of about 15 minutes, begins by fogging of hypertonic saline, and ends with the nasal and oral suction of the patient. The evaluation of clinical data is done 10 minutes before, 10 minutes later, 2 hours after physiotherapy treatment. The evaluation will be do it for a doctor who will, in all patients, a clinical examination that includes all items scale clinical severity of acute bronchiolitis.
Patient Registries:
SELECTION OF THE POPULATION Reference population. Patients diagnosed acute viral bronchiolitis during the conduct of the trial and have been admitted to the University Hospital Virgin of Arrixaca.
Sample size
The sample calculation was done considering a reduction of 2 points after physiotherapy in bronchiolitis severity scale. Whereas:
Variances: sames Detect mean difference: 2,000 Common standard deviation: 2,370 Ratio of sample sizes: 1,00 Confidence level: 95,0%
The standard deviation values were obtained from: JM Fernández Ramos et al Validation of a clinical scale of severity of acute bronchiolitis. An Pediatr (Barc). 2014; 81 (1): 3-8, article in which the mean and standard deviation (SD) score of patients admitted was 7 ± 2.37. There are no items to compare this scale before and after treatment, so the investigators have assumed that value of common standard deviation (SD) and whereas a decrease of 2 points on the scale post-physical therapy would be clinically relevant.
Power (%) Sample size Cases Control Total 85,0 27 27 54 90 31 31 62
Finally it was decided to increase to 60 cases / group considering that the number of losses may be higher (the investigators calculate 50%).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
application of hypertonic saline serum through a mask fogging or a box fogging
Passive expiratory aid implemented baby. the child is placed supine on a hard surface. Thoracoabdominal slow manual pressure that begins at the end of a spontaneous and continuous exhalation to residual volume is exercised. Oppose reaches 2 or 3 breaths. Vibrations can accompany the art. The goal is to achieve a greater expiratory volume.
Tp is based on the mechanism reflects cough induced by stimulation of the buttons on the wall of the trachea extrathoracic mechanoreceptors. The child is placed supine. A short pressure is done with the thumb on the tracheal conduit (in the sternal notch) at the end of inspiration, or at the beginning of expiration. With the other hand holding the abdominal region we prevent the dissipation of energy and make the explosion tussive more effective. It is done after the PSE.
After the inspiratory reflection following the PSE, the TP or crying. At the end of expiratory time the child's mouth is closed with the back of his hand just finished his chest support, raising the jaw and forcing the child to an inspiration with the nose
Suctioning with a probe by a vacuum system installed on the wall.
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 7 days
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 7 days
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 7 days
A questionnaire was filled out by parents or guardians of patients. After, the results of the survey will be analyzed by means of SPSS software
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 7 days
Universidad Católica San Antonio de Murcia
Other
FIBARRIX "Clinical Evaluation of the Response to Chest Physiotherapy in Infants With Acute Bronchiolitis"
Acronym: FIBARRIX
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