NiPPV in the Treatment of Acute Asthma Exacerbations

NCT03219736 | Withdrawn DMC FDA Device

• 1 other identifier: NiPPV Asthma
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Bronchial Asthma; Status Asthmaticus

Outcome Measures

Primary Outcomes (1)

• Decrease in the Pediatric Asthma Score within the designated time frame.

  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

  Every hour for a total of 8 hours

Secondary Outcomes (7)

• Time to decrease PAS to less than 4 within 8 hours of initiation of NiPPV/Bipap

  8 hours

• Measurement of volumetric end tidal CO2 trend with the NICO2® Respiratory volumetric capnography CO2 monitors.

  8 hours

• Analysis of flow loops captured by the NIPPV device.

  8 hours

• Changes in individual pulmonary parameters: respiratory rate

  8 hours

• Changes in individual pulmonary parameters: Oxygen requirement

  8 hours

Study Arms (2)

Control

ACTIVE COMPARATOR

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; Procedure: Routine Respiratory Care

NiPPV

ACTIVE COMPARATOR

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; Procedure: Routine Respiratory Care

Interventions

Standard of Care therapies PROCEDURE

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).

Control

NiPPV Therapy DEVICE

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.

Also known as: Bipap Therapy, Servo i ventilator by Maquet

NiPPV

Routine Respiratory Care PROCEDURE

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

Control; NiPPV

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Arkansas Children's Hospital Research Institute: lead

Study Sites (1)

Arkansas Children's Hospital

Little Rock, Arkansas, 72202, United States

Location

MeSH Terms

Conditions

Asthma; Status Asthmaticus

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Thomas J Abramo, MD

  UAMS/ACH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2014
• First Posted: July 17, 2017
• Study Start: June 1, 2017
• Primary Completion: January 1, 2019
• Study Completion: January 1, 2019
• Last Updated: February 22, 2023

Record last verified: 2022-06

Locations

US (1)