Heliox delivered by high flow nasal cannula in infants with acute bronchiolitis

• Register: ISRCTN
• Last refreshed on: 20 February 2017
• Main ID: ISRCTN99072045
• Date of registration: 26/01/2017
• Prospective Registration: Yes
• Primary sponsor: Mansoura University Children Hospital
• Public title: Heliox delivered by high flow nasal cannula in infants with acute bronchiolitis
• Scientific title: Heliox delivered by high flow nasal cannula improves oxygenation in Infants with respiratory syncytial virus acute bronchiolitis
• Date of first enrolment: 15/02/2017
• Target sample size: 80
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN99072045
• Study type: Interventional
• Study design: Single centre randomised controlled trial (Treatment)

Countries of recruitment

Kuwait

Contacts

• Name: Wael Seliem

Key inclusion & exclusion criteria

Inclusion criteria: 1. Infants aged from 1 month to 2 years old
2. Patients who are admitted to the pediatric high dependency unit, with RSV acute bronchiolitis diagnosed clinically confirmed by laboratory testing
3. Display the diagnostic criteria of bronchiolitis including cough, tachypnea, chest retraction, prolonged expiratory time, sibilant rhonchi, and hyperinflation of the lungs
3. Cannot maintain oxygen saturation = 93% in room air and require supplemental oxygen on admission to hospital
Exclusion criteria: 1. No informed consent obtained
2. Require mechanical ventilation
3. Congenital heart defect that is haemodynamically significant (significant left-to-right shunting with or without pulmonary hypertension or right-to-left shunting)
4. Underlying chronic lung disease including bronchopulmonary dysplasia and previously diagnosed hyper-reactive airway diseases

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Respiratory syncytial virus acute bronchiolitis
Respiratory
Respiratory syncytial virus acute bronchiolitis

Intervention(s)

Participants are randomly allocated to one of four blocks. These blocks are randomly allocated to one of two groups.

Group one (the intervention group) receive Heliox therapy (70:30) delivered through high flow nasal cannula continuously for 24 hours. If the oxygen saturation was kept = 93% despite the fraction of inspired oxygen of 30%, an increment of 5% was done to keep saturation >93%.

Group two (the control group) receive an air-oxygen mixture at 8 L/minute through a high flow nasal cannula continuously for 24 hours. If the oxygen saturation was kept = 93% despite the fraction of inspired oxygen of 30%, an increment of 5% was done to keep saturation >93%.

Participants are followed up at the end of the intervention (24 hours) to see if there is improvement in gas exchange and breathing.

Primary Outcome(s)

1. Partial arterial pressure and partial arterial oxygen are assessed using arterial blood samples at baseline, 2 hours and 24 hours
1.1. Oxygen saturation is assessed using pulse Masimo SET pulse oximeter continuously throughout the intervention
2. Respiratory distress is measured by the Modified Wood’s Clinical Asthma Score at 2 hours and 24 hours

Secondary Outcome(s)

Length of hospital stay is measured by reviewing patient notes at the end of hospital stay.

Secondary ID(s)

142281

Source(s) of Monetary Support

Investigator initiated and funded.