Bi-Level Positive Airway Ventilation for Acute Chest Syndrome

Stopped early · Not applicable · Has a placebo group

Conditions studied: Sickle Cell Anemia, Acute Chest Syndrome

In brief

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.

Key facts

Study ID

NCT01589926

Run by

Albert Einstein College of Medicine

People needed

3

Starts

2012-07-01

Expected to finish

2016-09-08

Last updated by the study team

2018-12-11

Who can join

Age: 4 and older, up to 21. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• patients diagnosed with Hemoglobin SS (HB SS), the most common type of sickle cell disease
• patients diagnosed with Hemoglobin SC (HB SC), the second most common type of sickle cell disease.
• patients diagnosed with Hemoglobin sickle beta-zero thalassemia ( HB SB0thal) or Hemoglobin sickle thalassemia (HB SBthal)
• Must meet clinical criteria for ACS- an infiltrate on Chest X-ray and one of the following:
• Respiratory symptoms/signs (patients pulse oximetry < 92% or oxygen saturation < 2% below their baseline, tachypnea, cough, and increased work of breathing)
• Fever
• Chest pain AND
• Patients' eligible for a simple transfusion based on one of the following criteria:
• Hypoxemia (patients pulse oximetry < 92% or oxygen saturation < 2% below their baseline)
• Hemoglobin < 5 gm/dl
• Increased work of breathing

You may not qualify if…

• Patient requires exchange transfusion within first 24 hours of admission
• Patient requires PCCU transfer within first 24 hours of admission
• Hemoglobin > 9gm/dl secondary to these patients requiring an exchange transfusion

Where it is running

• Children's Hospital @ Montefiore — The Bronx, New York, United States

Full record on ClinicalTrials.gov

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