Noninvasive Positive Airway Pressure in the Pediatric Emergency Department for the Treatment of Acute Asthma Exacerbations

Asthma Clinical Trial

— RCT BiPAP  

Official title:

A Randomized Controlled Trial of Noninvasive Positive Airway Pressure in the Pediatric Emergency Department for the Treatment of Acute Asthma Exacerbations

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01497691
• Other study ID #: 111491
• Status: Withdrawn
• Phase: N/A
• First received: December 16, 2011
• Last updated: August 22, 2017
• Start date: January 2013
• Est. completion date: November 19, 2013

Study information

• Verified date: August 2017
• Source: Vanderbilt University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Previous investigations and anecdotal experience have shown safety and utility of Noninvasive Positive Pressure Ventilation/Bilevel Positive Airway Pressure (NIPPV/BiPAP) for the treatment of asthma in children. If NIPPV/BiPAP can be shown to have a beneficial effect in children with respiratory insufficiency, emergency department and ICU stays may be shortened, and the need for more invasive and dangerous airway procedures may be decreased. This would result in a change in the standard of care for asthma treatment in emergency departments. The investigators hypothesis is that the use of this new NIPPV, in conjunction with current standard of care therapies, in acute moderate to severe asthma exacerbations will lead to a more rapid improvement in patient ventilation, faster resolution of respiratory distress, and overall improved secondary outcomes.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: November 19, 2013
• Est. primary completion date: November 19, 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 18 Years

Eligibility

Inclusion Criteria:

• 2-18 years old

• For subjects 3 years and older, a known history of asthma as diagnosed by the PCP or per the Vanderbilt problem list

• For children ages 2-3 years, four or more episodes of wheezing in the past year that lasted more than 1 day and affected sleep AND one of the following: parental history of asthma, a physician diagnosis of atopic dermatitis, or evidence of sensitization to aeroallergens

• Acute asthma exacerbation

• Pediatric Asthma Score (PAS) = 8

• Parents willing and able to sign consent

• Children over the age of 6 willing to provide assent

Exclusion Criteria:

• History of congenital heart disease, chronic respiratory disease including bronchopulmonary dysplasia, cystic fibrosis, pulmonary hypertension or any chronic lung disease other than asthma

• History of sickle cell disease

• Recently diagnosed pneumonia

• Current tracheostomy, on home ventilator or home oxygen requirement

• Recent diabetic ketoacidosis

• Requiring immediate intubation

• Weight less than 5 kilograms

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

• A history of prematurity of = 30 weeks gestation

Related Conditions & MeSH terms

• Asthma
• Emergencies

Intervention

Device:
• NIPPV (PALMtop PTV)
PALMtop PTV Models 8/10 aka CareFusion EnVe The primary study device is the PALMtop PTV. It is the NIPPV/BiPAP device used in this study. It is FDA approved for use in children who weigh 5 kilograms or greater (#K070594).
• Volumetric CO2 (NM3)
The NM3 is FDA approved (#K091459) for spirometric and carbon dioxide monitoring as well as continuous, non-invasive monitoring of arterial oxygen saturations and pulse rates in neonatal and pediatric patients in the emergency department.
• USCOM
The USCOM a non-invasive ultrasonic device that is FDA approved for monitor beat-to-beat cardiac hemodynamics in adult and pediatric patients (#K043139). It will be used in an attempt to better understand the underlying physiology of NIPPV use.

Locations

Country	Name	City	State
United States	Vanderbilt Children's Hospital	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Vanderbilt University Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Pediatric Asthma Score	The primary outcome indicator will be a decrease in PAS to = to 7 to occur 3 hours faster in the NIPPV/BiPAP group as compared to the control group (median expected time to PAS 7 = in BiPAP group is 5 hours; median expected time to PAS = 7 in control group is 8 hours; hazard ratio is 1.6). A total sample size of 366 (122 in each group) is required for 80% power and a significance level of 0.05 (2 tailed test). With an estimated 20% drop out rate will anticipate 147 subjects enrolled per arm for a total of 441 subjects enrolled.	Every 30 minutes while the subject is enrolled
Secondary	Volumetric end tidal CO2 trend	Measurement of volumetric end tidal CO2 trend with the NICO2® Respiratory volumetric capnography CO2 monitors	Continuous while the subject is enrolled
Secondary	Respiratory parameters	Analysis of flow loops captured by the NIPPV device, the delta pediatric asthma scores at each time point and changes in individual pulmonary parameters (respiratory rate, oxygen requirement, oxygen saturation).	Continuous while the subject is enrolled
Secondary	Cardiac output	Changes in cardiac parameters as measured by the USCOM	Continuous while the subject is enrolled
Secondary	Intubation and complication rates	Documentation of intubation rate and possible complications including but not limited to hypotension, vomiting, agitation, skin irritation, pneumothorax, barotrauma effects and death.	Continuous observation
Secondary	Length of hospital stay	Decrease length of hospital stay if placed on NIPPV. This will include looking at the disposition of the subject from the pediatric emergency department.	Retrospectively upon completion of study