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Bi-Level Positive Airway Ventilation for Acute Chest Syndrome

NCT01589926 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2018-12-11

Study results available
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Summary

Acute chest syndrome (ACS) is a frequent complication of sickle cell disease and is diagnosed by having findings on a chest x-ray and one of the following: chest pain, fever, or trouble breathing. Patients with Acute Chest Syndrome can get very sick and require an exchange transfusion (special large blood transfusion) and mechanical ventilation. Bi-level Positive Airway Pressure (also known as BLPAP or BiPAP) is a device that blows air into a patients lungs via a mask that covers the nose. The goal of this study is to determine whether giving children BiPAP when they have ACS, in addition to providing standard clinical care for ACS, alters the clinical course of these patients. The investigators hypothesize that patients receiving effective BiPAP will have milder clinical courses resulting in shorter hospital stays and fewer transfers to the intensive care unit and exchange transfusions.

Conditions

Interventions

DEVICE

Bi-level positive airway pressure device

BiPAP initiated for at least 16 hours per day for a minimum of 48hrs.

DEVICE

Sham CPAP

Sham CPAP initiated for at least 16 hours per day for a minimum of 48hrs.

Sponsors & Collaborators

  • Albert Einstein College of Medicine

    lead OTHER

Principal Investigators

  • Deepa Manwani, MD · Albert Einstein College of Medicine

  • Michael E Roth, MD · Albert Einstein College of Medicine

  • Kerry Morrone, MD · Albert Einstein College of Medicine

  • Hiren Muzumdar, MD · Albert Einstein College of Medicine

  • Ranaan Arens, MD · Albert Einstein College of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
4 Years
Max Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-07-31
Primary Completion
2016-09-08
Completion
2016-09-08
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01589926 on ClinicalTrials.gov