Bi-Level Positive Airway Ventilation for Acute Chest Syndrome
| Status: | Terminated |
|---|---|
| Conditions: | Anemia |
| Therapuetic Areas: | Hematology |
| Healthy: | No |
| Age Range: | 4 - 21 |
| Updated: | 12/13/2018 |
| Start Date: | July 2012 |
| End Date: | September 8, 2016 |
Early Bi-Level Positive Airway Pressure (BiPAP) Ventilation for Acute Chest Syndrome (ACS) - a Double-Blind Randomized Controlled Pilot Study
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.
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.
Acute chest syndrome (ACS) is a frequent complication of sickle cell disease and is diagnosed
by a new infiltrate on chest x-ray and one of the following: chest pain, fever, or
respiratory signs or symptoms (tachypnea, cough, new onset hypoxemia, or increased work of
breathing.)The treatment for acute chest syndrome is focused on supportive care with
hydration, antibiotics, blood transfusions and respiratory support. Unfortunately, despite
these treatments many patients fail to have improvements in their respiratory status, or have
respiratory decompensation. These patients require more aggressive treatments, which
frequently include exchange transfusions, pediatric intensive care unit (PCCU) management,
and respiratory support.
The study objective is to perform a prospective double blind randomized control trial to
investigate if early initiation of effective BiPAP in addition to providing standard clinical
care for ACS alters the clinical course of these patients vs. sham BiPAP and standard
clinical care. Investigators hypothesize that participants receiving effective BiPAP will
have milder clinical courses resulting in shorter hospital stays and fewer transfers to PCCU
and exchange transfusions.
by a new infiltrate on chest x-ray and one of the following: chest pain, fever, or
respiratory signs or symptoms (tachypnea, cough, new onset hypoxemia, or increased work of
breathing.)The treatment for acute chest syndrome is focused on supportive care with
hydration, antibiotics, blood transfusions and respiratory support. Unfortunately, despite
these treatments many patients fail to have improvements in their respiratory status, or have
respiratory decompensation. These patients require more aggressive treatments, which
frequently include exchange transfusions, pediatric intensive care unit (PCCU) management,
and respiratory support.
The study objective is to perform a prospective double blind randomized control trial to
investigate if early initiation of effective BiPAP in addition to providing standard clinical
care for ACS alters the clinical course of these patients vs. sham BiPAP and standard
clinical care. Investigators hypothesize that participants receiving effective BiPAP will
have milder clinical courses resulting in shorter hospital stays and fewer transfers to PCCU
and exchange transfusions.
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
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