Plain English Summary
Background and study aims
Respiratory syncytial virus bronchiolitis is a type of chest infection caused by a virus that affects infants, causing small tubes in the lungs to swell. Symptoms include a high temperature (fever), cough and difficulty breathing. Some infants have to be hospitalized in order to be given oxygen through a tube that goes over their nose or face to improve their breathing. Heliox (a mixture of oxygen and helium gases) may be given in order to improve breathing and provide more movement of air through airways that have become smaller due to the infection causing swelling in the lungs. Heliox is normally given using a ventilator which does the job of breathing for the patient through a tube inserted into the mouth. However, there are less invasive methods to provide Heliox such as through a high flow nasal cannula (HFNC) which continuously delivers air through a tube that is inserted into the nostrils. The aim of this study is to evaluate whether Heliox, when delivered through a HFNC, can help improve airflow for infants with bronchiolitis and decrease the need for more complicated therapies.
Who can participate?
Infants who are hospitalized for bronchiolitis
What does the study involve?
Participants are randomly allocated to one of two groups. Those in the first group are given the Heliox therapy continuously for 24 hours through a HFNC. Those in the second group are given oxygen continuously for 24 hours through a HFNC. Participants are followed up at the end of the intervention (after 24 hours) to see if there are improvements in the amount of oxygen found in their blood samples and if their breathing improved.
What are the possible benefits and risks of participating?
Participants may benefit from improvements in their breathing and it may relieve their symptoms. There is a risk that participants may feel discomfort when providing blood samples.
Where is the study run from?
Al Salam Hospital (Kuwait)
When is the study starting and how long is it expected to run for?
October 2016 to February 2018
Who is funding the study?
Investigator initiated and funded (Kuwait)
Who is the main contact?
Professor Wael Seliem
wseliem@hotmail.com
Trial website
Contact information
Type
Scientific
Primary contact
Prof Wael Seliem
ORCID ID
http://orcid.org/0000-0003-1304-5809
Contact details
Al Salam Hospital
Port Said St.
Bneid Al Qar Dasma
Kuwait
35151
Kuwait
+965 9667 6695
wseliem@hotmail.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
142281
Study information
Scientific title
Heliox delivered by high flow nasal cannula improves oxygenation in Infants with respiratory syncytial virus acute bronchiolitis
Acronym
Study hypothesis
The aim of the study is to evaluate whether the use of Heliox would result in an improvement of gas exchange when delivered through a high flow nasal cannula continuously (HFNC) in infants with respiratory syncytial virus (RSV) acute bronchiolitis.
Ethics approval
Mansoura University Faculty of Medicine MU, 25/12/2016, ref: 142281/2016
Study design
Single centre randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Respiratory syncytial virus acute bronchiolitis
Intervention
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.
Intervention type
Supplement
Phase
Drug names
Primary outcome measure
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 measures
Length of hospital stay is measured by reviewing patient notes at the end of hospital stay.
Overall trial start date
20/10/2016
Overall trial end date
15/02/2018
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
80
Participant 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
Recruitment start date
15/02/2017
Recruitment end date
15/11/2017
Locations
Countries of recruitment
Kuwait
Trial participating centre
Al Salam International Hospital
Port Said St
Bneid Al Qar Dasma
Kuwait City
35151
Kuwait
Funders
Funder type
Not defined
Funder name
Investigator initiated and funded.
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Planned publication in a high-impact peer reviewed journal.
IPD sharing plan:
The datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication
Intention to publish date
15/02/2019
Participant level data
Other
Basic results (scientific)
Publication list