Non-invasive Ventilation vs. Standard Therapy for Children Hospitalized With an Acute Exacerbation of Asthma

NCT03296579 | Unknown DMC

• 1 other identifier: H17-02008
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Asthma Acute; Asthma in Children

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Time to room air

  Patients will be followed for the duration of their hospital stay (an estimated average of 4 days).

• Total medication use per 12 hr period

  Patients will be followed for the duration of their hospital stay (an estimated average of 4 days).

• Numbers failing treatment and transferred to ICU

  Patients will be followed for the duration of their hospital stay (an estimated average of 4 days).

Other Outcomes (1)

• Time to reach FEV1 >80% predicted in those children able to perform pulmonary function tests

  Patients will be followed for the duration of their hospital stay (an estimated average of 4 days).

Study Arms (3)

Conventional asthma therapy.

ACTIVE COMPARATOR

Bilevel Positive Airway Pressure group(BiPAP). BiPAP settings at 15/5 cm H2O by face mask with background rate 10 to 15/min. Standard steroid dose plus hourly salbutamol and oxygen to keep SaO2 \> 92%.

Drug: Ipratropium; Drug: Magnesium Sulfate; Drug: Aminophylline; Drug: Standard steroid dose, hourly salbutamol, oxygen as needed

Non-invasive ventilation (CPAP).

EXPERIMENTAL

Continuous Positive Airway Pressure group (CPAP). CPAP settings at 8 to 10 cm H2O. Standard steroid dose plus hourly salbutamol and oxygen to keep SaO2 \> 92%.

Device: CPAP; Drug: Standard steroid dose, hourly salbutamol, oxygen as needed

Non-invasive ventilation (BiPAP)

EXPERIMENTAL

Standard steroid dose, hourly salbutamol, oxygen as needed, nebulized ipratropium q 6 hrly, magnesium sulfate 50 mg/kg IV (4 doses q 6 hrly), loading dose of aminophylline 6 mg/kg IV if no progress.

Device: BiPAP; Drug: Standard steroid dose, hourly salbutamol, oxygen as needed

Interventions

BiPAP DEVICE

The patient's breathing is assisted by cycling between high and low pressures at a pre-set rate.

Also known as: Trilogy BiPAP, Bilevel Positive Airway Pressure

Non-invasive ventilation (BiPAP)

CPAP DEVICE

The patient breathes against a constant pressure delivered by face mask.

Also known as: Continuous Positive Airway Pressure

Non-invasive ventilation (CPAP).

Ipratropium DRUG

Nebulized q6h

Conventional asthma therapy.

Magnesium Sulfate DRUG

50mg/kg IV, 4 doses q6h

Conventional asthma therapy.

Aminophylline DRUG

6mg/kg IV (if no progress)

Conventional asthma therapy.

Standard steroid dose, hourly salbutamol, oxygen as needed DRUG

Standard common therapies for all three arms.

Conventional asthma therapy.; Non-invasive ventilation (BiPAP); Non-invasive ventilation (CPAP).

Eligibility Criteria

• Age: 2 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of British Columbia: lead
• Post Graduate Institute of Medical Education and Research, Chandigarh: collaborator

Related Publications (10)

• 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.

  PMID: 24925892 BACKGROUND

• 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.

  PMID: 22067982 BACKGROUND

• 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.

  PMID: 18346499 BACKGROUND

• 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.

  PMID: 24041942 BACKGROUND

• 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.

  PMID: 19616722 BACKGROUND

• British Thoracic Society Standards of Care Committee. Non-invasive ventilation in acute respiratory failure. Thorax. 2002 Mar;57(3):192-211. doi: 10.1136/thorax.57.3.192. No abstract available.

  PMID: 11867822 BACKGROUND

• 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.

  PMID: 23798903 BACKGROUND

• 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.

  PMID: 19911854 BACKGROUND

• 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.

  PMID: 28139368 BACKGROUND

• 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.

  PMID: 20956164 BACKGROUND

MeSH Terms

Interventions

Continuous Positive Airway Pressure; Ipratropium; Magnesium Sulfate; Aminophylline; Oxygen; Health Services Needs and Demand

Intervention Hierarchy (Ancestors)

Positive-Pressure Respiration; Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy; Atropine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Organic Chemicals; Belladonna Alkaloids; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring; Magnesium Compounds; Inorganic Chemicals; Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds; Ethylenediamines; Diamines; Polyamines; Amines; Theophylline; Xanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Drug Combinations; Pharmaceutical Preparations; Chalcogens; Elements; Gases; Health Services Research; Health Planning; Health Care Economics and Organizations; Delivery of Health Care; Health Care Quality, Access, and Evaluation

Study Officials

• Michael Seear

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael Seear, MD

CONTACT

6048752000; mseear@cw.bc.ca

Terry Viczko

CONTACT

6048752345; tviczko@bcchr.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: It is not possible to use non-invasive face masks on the control patients so the study is unblinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 21, 2017
• First Posted: September 28, 2017
• Study Start: June 1, 2018
• Primary Completion: November 1, 2018
• Study Completion: December 1, 2018
• Last Updated: May 2, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share