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NCT Number: NCT02853838

Chest Physiotherapy in Infants Between 0 and 12 Months Old With Acute Bronchiolitis SRV(+)

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.

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Key information

Conditions

Bronchiolitis, Viral Bronchial Diseases Bronchiolitis Bronchitis Infections Lung Diseases Lung Diseases, Obstructive Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

15 day–12 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Padre Hurtado

Santiago, Santiago Metropolitan, Chile

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Clinical diagnosis of bronchiolitis.
  • RSV positive in direct immunofluorescence assay.
  • Wang clinical severity score ≥ 4 points.

Exclusion criteria

  • Patients with heart or neurological diseases.
  • Previous episodes of wheezing.
  • Chronic conditions such as bronchopulmonary dysplasia, immunodeficiency, or congenital diseases.
  • Need of mechanical ventilation in Intensive Care Unit
  • Contraindication criteria for chest physiotherapy (i.e. Pneumothorax, ribs fractures, hemodynamic instability).
  • Patients not receiving supplementary oxygen.

Treatment and study plan

Prolonged slow expiration+provoked coughing

Other

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.

Manual chest wall vibration

Other

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

Other

Standard therapy (ST): nasopharyngeal suction, oxygen therapy, fluids administration, 0.5% adrenaline nebulization, and chest physiotherapy.

Primary outcomes

  1. Clinical score of respiratory distress

    Time frame: 48 hours after baseline measurement

    Wang clinical severity score

Secondary outcomes

  1. Hours of supplementary oxygen

    Time frame: 48 hours after baseline measurement

  2. Peripheral blood oxygen level

    Time frame: Baseline, 30 min, 60 min, 120 min,12 hours, 24 hours, 36 hours, and 48 hours.

    Oxygen level or saturation is measured with a pulse oximeter

  3. Heart rate

    Time frame: Baseline, 30 min, 60 min, 120 min,12 hours, 24 hours, 36 hours, and 48 hours.

  4. Respiratory rate

    Time frame: Baseline, 30 min, 60 min, 120 min,12 hours, 24 hours, 36 hours, and 48 hours.

    Wang clinical severity score

  5. wheezing

    Time frame: Baseline, 30 min, 60 min, 120 min,12 hours, 24 hours, 36 hours, and 48 hours.

    Wang clinical severity score

  6. Rib cage retractions

    Time frame: Baseline, 30 min, 60 min, 120 min,12 hours, 24 hours, 36 hours, and 48 hours.

    Wang clinical severity score

  7. General clinical condition

    Time frame: Baseline, 30 min, 60 min, 120 min,12 hours, 24 hours, 36 hours, and 48 hours.

    Wang clinical severity score

Other outcomes

  1. Transfer to high complexity unit

    Time frame: 96 hours

    Categorical variable. Record of number of patients requiring treatment at a higher complexity unit (i.e. ICU)

Sponsors and collaborators

Lead sponsor

Universidad del Desarrollo

Other

Collaborators

  • Hospital Padre Hurtado

Registry information

Official study title

Effectiveness of Chest Physiotherapy in Infants Hospitalized With Acute Bronchiolitis SRV (+): a Randomized Controled Trial

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Aug 3, 2016
Registry last updated
Oct 26, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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