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NiPPV in the Treatment of Acute Asthma Exacerbations

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ClinicalTrials.gov Identifier: NCT03219736
Recruitment Status : Withdrawn (PI could not get support for project)
First Posted : July 17, 2017
Last Update Posted : January 14, 2019
Sponsor:
Information provided by (Responsible Party):
Arkansas Children's Hospital Research Institute

Brief Summary:

Study Summary:

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

Principal Investigator: Thomas J. Abramo, MD

Hypothesis: For acute moderate to severe pediatric asthma exacerbations the use of NIPPV/BiPAP, in conjunction with current standard of care therapies, will lead to a more rapid improvement in patient ventilation, faster resolution of respiratory distress and result in improved ventilatory parameters, secondary outcomes and pediatric asthma scores.

Study Design: Prospective, randomized controlled trial

Study Duration: This study will be conducted over a 36 month period.

Sample Size: 240 subjects

Population: Children ages 2-17 years of age presenting to the ED with Acute asthma exacerbation and a Pediatric Asthma Score (PAS) ≥ 8.

Synopsis: Eligible subjects will be randomized to either a control group or study groups. The study groups will be either a NIPPV/BiPAP group. The subjects in the study groups will continue to receive all standard of care therapies per the asthma severity protocols. All nebulized therapies will be given through the NIPPV circuit. Patients will be assessed by the pediatric asthma score (PAS), measured respiratory parameters, volumetric end tidal carbon dioxide monitoring and measured cardiac parameters.

Objectives: A. Evaluate if the use of NIPPV/BiPAP in conjunction with traditional inhaled beta-agonists improves the outcome in pediatric patients with acute moderate to severe asthma in the acute setting.

B. Describe the physiology of NIPPV/BiPAP by measuring cardiac parameters in children randomized to a NIPPV group.

C. Monitor safety of NIPPV/BiPAP use for acute asthma exacerbations in children.

Safety A.: The study must be IRB approved.

B.: Appropriate consent and assent documents will be obtained prior to enrolling the subject in the study.

C.: A clear safety plan including DSMB will be established to monitor for adverse events.

D.: Confidentiality will be ensured for all subjects enrolled in the study.


Condition or disease Intervention/treatment Phase
Bronchial Asthma Status Asthmaticus Procedure: Standard of Care therapies Device: NiPPV Therapy Procedure: Routine Respiratory Care Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial of Non-Invasive Positive Airway Pressure in the Pediatric Emergency Department for the Treatment of Acute Asthma Exacerbations
Actual Study Start Date : June 1, 2017
Estimated Primary Completion Date : August 1, 2020
Estimated Study Completion Date : December 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arm Intervention/treatment
Active Comparator: Control
This group will receive all standard of care therapies as per the pediatric ED Asthma Severity Protocol. To summarize, all moderate and severe acute asthma exacerbations receive albuterol and atrovent continuous aerosols, oral or intravenous steroids and intravenous magnesium sulfate. At the discretion of the treating physician, the patient may also receive subcutaneous terbutaline or epinephrine
Procedure: Standard of Care therapies
If at any point during the treatment it is deemed medically necessary by the treating PED attending that a subject from the control arm (Group 1) requires an escalation of therapy, they may be moved from the group to the NIPPV/BiPAP group (Group 2) or be removed from the study (i.e. if intubated).

Procedure: Routine Respiratory Care
It may be up to the treating physicians discretion to treat patient with other medications that are currently used to treat severe asthma exacerbations, such as Epinephrine and Terbutaline

Active Comparator: NiPPV
This group will receive all standard of care therapies as per the pediatric ED Asthma Severity Protocol. All nebulized treatments will be given via the NIPPV/BiPAP machine (EnVe Ventilator). Optimal settings for each participant should be achieved within 20 minutes of initiation of NiPPV. Pediatric asthma scores will continue to be recorded at least every hour or with every physician suggested NIPPV ventilator setting change for an 8 hour period. Furthermore, the NIPPV machine in conjunction with NM3 volumetric end tidal CO2 monitoring will record ventilatory data in this NIPPV/BiPAP group and will be compared to other study groups. The subjects will remain in the study for minimum of 4 hrs NIPPV therapy and total of 8 hours.
Device: NiPPV Therapy
If at any point during the treatment it is deemed medically necessary by the treating PED attending that a subject from a NIPPV/BiPAP group (Group 2) is not tolerating NIPPV they may be removed from the study. Patients may not tolerate NIPPV due to agitation, vomiting or need for escalation of care.
Other Name: Bipap Therapy, Servo i ventilator by Maquet

Procedure: Routine Respiratory Care
It may be up to the treating physicians discretion to treat patient with other medications that are currently used to treat severe asthma exacerbations, such as Epinephrine and Terbutaline




Primary Outcome Measures :
  1. Decrease in the Pediatric Asthma Score within the designated time frame. [ Time Frame: Every hour for a total of 8 hours ]
    The Research coordinator or Respiratory Therapist will measure a PAS every hour for a total of 8 hours with the goal of lowering the PAS


Secondary Outcome Measures :
  1. Time to decrease PAS to less than 4 within 8 hours of initiation of NiPPV/Bipap [ Time Frame: 8 hours ]
    The goal of the treatment strategy is to lower the PAS to less than 4 so that the patient may be transitioned from the NiPPV/Bipap to standard oxygen therapy for the treatment of an exacerbation of their asthma

  2. Measurement of volumetric end tidal CO2 trend with the NICO2® Respiratory volumetric capnography CO2 monitors. [ Time Frame: 8 hours ]
    The goal of the therapy is to be able to reduce the amount of inspiratory pressure the patient receives as their disease process improves. We hope to measure this with the end-tidal CO2 device. When the exhaled CO2 trends down we hope to reduce the inspiratory pressure the patient is receiving via NiPPV/BiPAP

  3. Analysis of flow loops captured by the NIPPV device. [ Time Frame: 8 hours ]
    By the Respiratory therapist and physician examining the flow volume loops from the patient data, we hope to capture the time that the patients lungs have seen a reduction in bronchospasms

  4. Changes in individual pulmonary parameters: respiratory rate [ Time Frame: 8 hours ]
    By adding NiPPV/Bipap to the patient to increase their inspiratory pressure while receiving their respiratory medications, we hope to be able to get the medications to the lower airways faster to help patient recover faster from asthma exacerbation which will hopefully reduce patient's length of stay in the hospital

  5. Changes in individual pulmonary parameters: Oxygen requirement [ Time Frame: 8 hours ]
    By adding NiPPV/Bipap to the patient to increase their inspiratory pressure while receiving their respiratory medications, we hope to be able to get the medications to the lower airways faster to help patient recover faster from asthma exacerbation which will hopefully reduce patient's length of stay in the hospital

  6. Changes in individual pulmonary parameters: Oxygen saturations [ Time Frame: 8 hours ]
    By adding NiPPV/Bipap to the patient to increase their inspiratory pressure while receiving their respiratory medications, we hope to be able to get the medications to the lower airways faster to help patient recover faster from asthma exacerbation which will hopefully reduce patient's length of stay in the hospital

  7. Changes in cardiac parameters as measured by the USCOM, to include intubation rates, decrease length of hospital stay, limited need for additional treatments, ICU admission, barotrauma effects, and death. [ Time Frame: 8 hours ]
    We hope to show improvements in Cardiac output measurements from the start of therapy until after treatment has been discontinued. We hope to show in increase in cardiac output due to the decrease in air trapping that is caused when a patient is undergoing an asthma exacerbation.



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Ages Eligible for Study:   2 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 2-17 years old
  • For subjects 3 years and older, a known history of asthma as diagnosed by the PCP or per the ACH 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03219736


Locations
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United States, Arkansas
Arkansas Children's Hospital
Little Rock, Arkansas, United States, 72202
Sponsors and Collaborators
Arkansas Children's Hospital Research Institute
Investigators
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Principal Investigator: Thomas J Abramo, MD UAMS/ACH

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Responsible Party: Arkansas Children's Hospital Research Institute
ClinicalTrials.gov Identifier: NCT03219736     History of Changes
Other Study ID Numbers: NiPPV Asthma
First Posted: July 17, 2017    Key Record Dates
Last Update Posted: January 14, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
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Asthma
Status Asthmaticus
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases