An interventional study of Prolonged slow expiration+provoked coughing and Manual chest wall vibration in Bronchiolitis, Viral, sponsored by Universidad del Desarrollo. Completed at 1 site in Chile. Open to participants aged 15 Days to 12 Months. Per ClinicalTrials.gov, last updated 2016-10-26.
Sponsored by Universidad del Desarrollo · Not applicable, Interventional, and Treatment
The purpose of this research is to determine the effect of prolonged slow expiration techniques, provoked coughing and standard therapy compared to chest wall manual vibration and standard therapy in infants between 0 and 12 months old with confirmed diagnosis of acute bronchiolitis SRV (+). The effect will be measured on respiratory insufficiency and use of supplementary oxygen.
Bronchiolitis is the main cause of hospital admission for infants under 1 year old in Chile. Currently, approximately 4800 children are admitted to the hospital during the cold season, affecting the health services' effectiveness. The most frequent causal agent is the Respiratory Syncytial Virus (RSV). To date, there is no specific treatment for this disease and only support measures are recommended.
Chest physiotherapy is a support measure that improves the mucociliary clearance and reduces obstruction of the airways.
A clinical trial on the effect of prolonged slow expiration (PSE), chest wall vibrations, and provoked coughing as treatment for bronchiolitis in infants admitted to the hospital found that the subgroup with RSV required oxygen for 10 hours less than the control group. Gomes and Postiaux (2012) reported a 50% decrease on respiratory distress measured by the Wang score when PSE and suction were compared to traditional chest physiotherapy techniques in patients with bronchiolitis RSV(+).
Currently recommendations in Chile suggest chest physiotherapy for outpatients with bronchiolitis, but the guideline does not refer to the case of inpatients. It is proposed to carry out a randomized controlled trial in infants under one year old. The active group will receive standard therapy, PSE, and provoked coughing, while the control group will receive standard therapy and manual chest wall vibrations. The effectiveness of chest physiotherapy will be measured though a clinical score of respiratory distress, hours using supplementary oxygen, vital signs before and after the intervention in both groups during hospital stay. The main outcome is clinical severity score 48 hours after admission.
30 studies on the registry are indexed under Bronchiolitis, Viral; 2 are open to participants now.
This study's enrollment of 204 is above the median of 85 across 25 interventional studies indexed under Bronchiolitis, Viral.
Browse Bronchiolitis, Viral studies →Universidad del Desarrollo is the lead sponsor of 24 studies on the registry; 8 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Prolonged slow expiration+provoked coughing+Standard Therapy
Other: Prolonged slow expiration+provoked coughing · Other: Standard Therapy
Manual chest wall vibration+Standard Therapy
Other: Manual chest wall vibration · Other: Standard Therapy
Five cycles of prolonged slow expiration and provoked coughing, which will be repeated five times. During the prolonged slow expiration, the infant will be in supine while the therapist applies pressure at the same time on the rib cage and abdomen during spontaneous expiration. The pressure is applied slowly during two o three respiratory cycles, only during the final phase of expiration.
Five cycles of manual chest wall vibrations during 20 seconds each, being repeated five times. The manual chest wall vibrations are oscillatory maneuvers applied on the thorax to improve mucociliary clearance of bronchial mucus and ease its removal.
Standard therapy (ST): nasopharyngeal suction, oxygen therapy, fluids administration, 0.5% adrenaline nebulization, and chest physiotherapy.
Clinical score of respiratory distress
Wang clinical severity score
Time frame: 48 hours after baseline measurement
Hours of supplementary oxygen
Time frame: 48 hours after baseline measurement
Peripheral blood oxygen level
Oxygen level or saturation is measured with a pulse oximeter
Time frame: Baseline, 30 min, 60 min, 120 min,12 hours, 24 hours, 36 hours, and 48 hours.
Heart rate
Time frame: Baseline, 30 min, 60 min, 120 min,12 hours, 24 hours, 36 hours, and 48 hours.
Respiratory rate
Wang clinical severity score
Time frame: Baseline, 30 min, 60 min, 120 min,12 hours, 24 hours, 36 hours, and 48 hours.
wheezing
Wang clinical severity score
Time frame: Baseline, 30 min, 60 min, 120 min,12 hours, 24 hours, 36 hours, and 48 hours.
Rib cage retractions
Wang clinical severity score
Time frame: Baseline, 30 min, 60 min, 120 min,12 hours, 24 hours, 36 hours, and 48 hours.
General clinical condition
Wang clinical severity score
Time frame: Baseline, 30 min, 60 min, 120 min,12 hours, 24 hours, 36 hours, and 48 hours.
Transfer to high complexity unit
Categorical variable. Record of number of patients requiring treatment at a higher complexity unit (i.e. ICU)
Time frame: 96 hours
Plan to share: Undecided — Data will be made available, If journal where report will be published requires to give access to individual patient data
No publications or documents are linked to this record.
This study is completed, as verified in Oct 2016. You cannot join it, but the record below documents what was studied.
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Universidad del Desarrollo