Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03296579
Other study ID # H17-02008
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date June 2018
Est. completion date December 2018

Study information

Verified date April 2018
Source University of British Columbia
Contact Michael Seear, MD
Phone 6048752000
Email mseear@cw.bc.ca
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Acute asthma produces greatly increased work of breathing and increased oxygen requirement secondary to bronchial narrowing and airway obstruction by inflammatory secretions. There is growing evidence that non-invasive ventilation can reverse these processes more efficiently than conventional asthma therapy. Surprisingly, there have not yet been any large scale prospective controlled studies to investigate this hypothesis, (either in adults or children). Consequently, the aim of this study is to determine if the use of non-invasive positive airway pressure, for children admitted to hospital with an acute exacerbation of asthma, reduces their work of breathing, need for adjunctive medications, and shortens the length of hospital stay, compared to current standard therapy.


Description:

The aim of the study is to determine if the use of NIV, for children admitted to hospital with an acute exacerbation of asthma, reduces their work of breathing, need for adjunctive medication, length of hospital stay, and need for intubation and mechanical ventilation. Study design will be prospective, randomized and controlled. The tightly fitting face mask necessary for NIV makes it impossible to make this a blinded study.

The principal enrollment criteria will be children over 2 years of age presenting to the ER with acute asthma. After diagnosis, all children are treated with standard therapy (systemic steroids plus 3 doses of inhaled salbutamol and 1 dose of inhaled ipratropium over a 1 hour period then hourly salbutamol). The principal decision between discharge track and admission track will be made at 2 hours after first steroid dose. Admission criteria are based on sequential PRAM scores.

After initial asthma treatment and observation in the emergency room, to determine which patients can be discharged home, those who need admission will be asked to join the study, then consented and randomized. There will be three treatment groups:

- BiPAP: standard steroid dose, hourly salbutamol and BiPAP at 15/5 cm H2O by face mask with rate 10 to 15/min, oxygen as needed.

- CPAP: standard steroid dose, hourly salbutamol and 8 to 10 cm H2O constant pressure by face mask, oxygen as needed.

- Conventional therapy: standard steroid dose plus hourly nebulized salbutamol, nebulized ipratropium q 6 hrly, magnesium sulphate 50 mg/kg IV (4 doses q 6 hrly), loading dose of aminophylline 6 mg/kg IV if no progress, oxygen as needed.

All children will be admitted to a small 3 bed respiratory unit. They will be closely monitored and objectively scored every 4 hours using the PRAM asthma clinical severity score (Pediatric Respiratory Assessment Measure). Projected patient enrollment will be at least 30 in each arm. Estimated study duration is 6 months.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 100
Est. completion date December 2018
Est. primary completion date November 2018
Accepts healthy volunteers No
Gender All
Age group 2 Years to 18 Years
Eligibility Inclusion Criteria:

- 2-18 years old

- Clinical diagnosis of acute asthma exacerbation (respiratory rate greater than WHO's age-dependent criteria, a history of similar previous episodes and wheezing heard on auscultation by an experienced physician)

- PRAM score of 8 or more after 2 hours post-steroid administration

- Parents willing and able to sign consent

- Children over the age of 6 willing to provide assent

Exclusion Criteria:

- Clinical suspicion of bacterial pneumonia: focal crackles or bronchial breathing, and/or major chest x-ray findings.

- Impending respiratory failure at presentation requiring direct PICU admission

- Any contraindication to BiPAP use including altered mental status, recent bowel surgery, intractable vomiting, inability to protect airway, pneumothorax.

- Receiving maintenance dose of oral steroid at time of hospital admission

- History of serious unrelated illness such as congenital heart disease or bronchopulmonary dysplasia.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
BiPAP
The patient's breathing is assisted by cycling between high and low pressures at a pre-set rate.
CPAP
The patient breathes against a constant pressure delivered by face mask.
Drug:
Ipratropium
Nebulized q6h
Magnesium Sulfate
50mg/kg IV, 4 doses q6h
Aminophylline
6mg/kg IV (if no progress)
Standard steroid dose, hourly salbutamol, oxygen as needed
Standard common therapies for all three arms.

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
University of British Columbia Post Graduate Institute of Medical Education and Research, Chandigarh

References & Publications (10)

Basnet S, Mander G, Andoh J, Klaska H, Verhulst S, Koirala J. Safety, efficacy, and tolerability of early initiation of noninvasive positive pressure ventilation in pediatric patients admitted with status asthmaticus: a pilot study. Pediatr Crit Care Med. 2012 Jul;13(4):393-8. doi: 10.1097/PCC.0b013e318238b07a. — View Citation

British Thoracic Society Standards of Care Committee. Non-invasive ventilation in acute respiratory failure. Thorax. 2002 Mar;57(3):192-211. — View Citation

Ducharme FM, Chalut D, Plotnick L, Savdie C, Kudirka D, Zhang X, Meng L, McGillivray D. The Pediatric Respiratory Assessment Measure: a valid clinical score for assessing acute asthma severity from toddlers to teenagers. J Pediatr. 2008 Apr;152(4):476-80, 480.e1. doi: 10.1016/j.jpeds.2007.08.034. Epub 2007 Oct 31. — View Citation

Gowraiah V, Awasthi S, Kapoor R, Sahana D, Venkatesh P, Gangadhar B, Awasthi A, Verma A, Pai N, Seear M. Can we distinguish pneumonia from wheezy diseases in tachypnoeic children under low-resource conditions? A prospective observational study in four Indian hospitals. Arch Dis Child. 2014 Oct;99(10):899-906. doi: 10.1136/archdischild-2013-305740. Epub 2014 Jun 12. — View Citation

Green E, Jain P, Bernoth M. Noninvasive ventilation for acute exacerbations of asthma: A systematic review of the literature. Aust Crit Care. 2017 Nov;30(6):289-297. doi: 10.1016/j.aucc.2017.01.003. Epub 2017 Jan 27. Review. — View Citation

Martinez FD, Vercelli D. Asthma. Lancet. 2013 Oct 19;382(9901):1360-72. doi: 10.1016/S0140-6736(13)61536-6. Epub 2013 Sep 13. Review. — View Citation

Nava S, Hill N. Non-invasive ventilation in acute respiratory failure. Lancet. 2009 Jul 18;374(9685):250-9. doi: 10.1016/S0140-6736(09)60496-7. Review. — View Citation

Nievas IF, Anand KJ. Severe acute asthma exacerbation in children: a stepwise approach for escalating therapy in a pediatric intensive care unit. J Pediatr Pharmacol Ther. 2013 Apr;18(2):88-104. doi: 10.5863/1551-6776-18.2.88. — View Citation

Papiris SA, Manali ED, Kolilekas L, Triantafillidou C, Tsangaris I. Acute severe asthma: new approaches to assessment and treatment. Drugs. 2009;69(17):2363-91. doi: 10.2165/11319930-000000000-00000. — View Citation

Soroksky A, Klinowski E, Ilgyev E, Mizrachi A, Miller A, Ben Yehuda TM, Shpirer I, Leonov Y. Noninvasive positive pressure ventilation in acute asthmatic attack. Eur Respir Rev. 2010 Mar;19(115):39-45. doi: 10.1183/09059180.00006109. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other Time to reach FEV1 >80% predicted in those children able to perform pulmonary function tests Standard pulmonary function tests can usually be performed by children >6 years. Patients will be followed for the duration of their hospital stay (an estimated average of 4 days).
Primary Time to reach a PRAM score of =3 PRAM score includes assessment of oxygen saturations, suprasternal retractions, scalene muscle contraction, air entry and wheezing. Patients will be followed for the duration of their hospital stay (an estimated average duration of 4 days)
Secondary Time to room air Time that oxygen is required Patients will be followed for the duration of their hospital stay (an estimated average of 4 days).
Secondary Total medication use per 12 hr period Comparison of total medication use by children in each arm. Patients will be followed for the duration of their hospital stay (an estimated average of 4 days).
Secondary Numbers failing treatment and transferred to ICU Number of patients in each group that fail treatment and require transfer to ICU Patients will be followed for the duration of their hospital stay (an estimated average of 4 days).
See also
  Status Clinical Trial Phase
Completed NCT04450108 - Vivatmo Pro™ for Fractional Exhaled Nitric Oxide (FeNO) Monitoring in U.S. Asthmatic Patients N/A
Recruiting NCT05734261 - Forced Oscillations Technique During a Metacholine Test in Children N/A
Recruiting NCT06044051 - Dynamics of the Upper and Lower Airway Respiratory Microbiomes Associated With Severe Infant Asthma N/A
Completed NCT04896502 - Effectiveness of Telemedicine Home Assessments for Identification and Reduction of Asthma Triggers N/A
Completed NCT03503812 - Mitigating the Health Effects of Desert Dust Storms Using Exposure-Reduction Approaches N/A
Recruiting NCT06003569 - Reducing Asthma Attacks in Disadvantaged School Children With Asthma N/A
Not yet recruiting NCT05902702 - Isotonic Saline for Children With Bronchiolitis N/A
Not yet recruiting NCT05547477 - Continuous EMG Measurements in Children With Asthma During Sleep
Completed NCT04388098 - Oral Health Status of Asthmatic Children
Terminated NCT03586544 - Reducing Exercise-induced Bronchoconstriction in Children With Asthma and Obesity Phase 4
Recruiting NCT04821908 - Consequences of COVID 19 Pandemic on Childhood Asthma
Not yet recruiting NCT03277170 - Pragmatic RCT of High-dose Oral Montelukast for Moderate and Severe Pediatric Acute Asthma Exacerbations Phase 2
Enrolling by invitation NCT06239844 - Navigating Together for Equitable Asthma Management for Children in Families Who Communicate in Language Other Than English N/A
Not yet recruiting NCT05997784 - Study of Indoor Air Pollutants and Their Impact in Childhood Health and Wellbeing
Not yet recruiting NCT05974917 - Serious gaMes as Emerging E-health Interventions for Young People With neurologicaL or rEspiratory disoRders
Recruiting NCT05366309 - Performance and Adherence in Children Using Spacers N/A
Completed NCT05684926 - COVID-19 Pandemic Asthma Child Telerehabilitation Yoga N/A
Recruiting NCT04166344 - A mHealth Intervention to Improve Symptom Control in Children and Adolescents With Difficult-to-control Asthma N/A
Completed NCT03673618 - Soluble Corn Fiber Supplementation for Asthma Phase 2
Completed NCT05576142 - Oral Findings in Pediatric Patients With Allergic Rhinitis and/or Asthma