A Prospective Trial of BiPAP Administration vs. Non-positive Pressure Therapy for Pediatric Status Asthmaticus

Status Asthmaticus Clinical Trial

Official title:

A Prospective, Randomized Trial of Early Versus Delayed BiPAP Administration or Non-positive Pressure Therapy in the Management of Pediatric Status Asthmaticus

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02539420
• Other study ID #: 14-245
• Status: Withdrawn
• Phase: N/A
• First received: August 26, 2015
• Last updated: April 25, 2016
• Start date: April 2016

Study information

• Verified date: April 2016
• Source: Northwell Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Though BiPAP is an increasingly common tool used by pediatric critical care physicians and there is promising data suggesting a role for BiPAP in the management of status asthmaticus, more information is needed to more definitively clarify the extent of its benefit, as well as when during an asthma exacerbation and in whom it is the most beneficial. In this study, which is among the first randomized studies of BiPAP use for status asthmaticus in the pediatric population, the investigators hope to better elucidate these issues to help guide clinicians' future management decisions.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. primary completion date: April 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 4 Years to 17 Years

Eligibility

Inclusion Criteria:

• Primary diagnosis of asthma exacerbation

• Admitted to Cohen Children's Medical Center (CCMC) PICU

• CCMC respiratory severity score of 6 or higher at the time of enrollment

• Prior history of asthma or reactive airway disease

Exclusion Criteria:

• No prior history of asthma or reactive airway disease

• Facial or airway anomalies precluding BiPAP mask use

• Tracheostomy

• Lack of airway protective reflexes

• Neurologic or musculoskeletal abnormalities affecting respiration

• Underlying cardiovascular problems that may be negatively affected by positive pressure ventilation

• Intracranial problems (such as in the setting of head injury) that may be negatively affected by positive pressure ventilation

• Respiratory compromise for which emergent endotracheal intubation or non-invasive positive pressure ventilation is warranted as determined by the on-service attending physician

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Status Asthmaticus

Intervention

Device:
• BiPAP treatment
Patients will receive BiPAP (via Respironics V60 or Vision BIPAP device) as part of their treatment for status asthmaticus

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Northwell Health	Feinstein Institute for Medical Research

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical Asthma Scores	Both PRAM and CCMC clinical asthma scores	3 hours after enrollment	No
Secondary	Dyspnea Scores	Modified Borg Scale and Wong Baker Faces Scale	0 hours, 3 hours, 6 hours, 9 hours, 12 hours, 24 hours, and 36 hours after enrollment	No
Secondary	BiPAP Tolerance	Tolerability of BiPAP will be determined by patients keeping the mask on and agreeing to remain on the machine for the intended treatment period.	Hospitalization	No
Secondary	Length of stay in intensive care unit (ICU)		ICU stay -- Expected to be approximately 3 days on average	No
Secondary	Length of stay in hospital		Hospital length of stay -- Expected to be approximately 5 days on average	No
Secondary	Side effects or adverse events		Hospitalization	Yes
Secondary	Clinical Asthma Scores		0 hours, 6 hours, 9 hours, 12 hours, 24 hours, and 36 hours after enrollment	No