Ignite Creation Date:
2024-05-06 @ 12:28 AM
Last Modification Date:
2024-10-26 @ 10:50 AM
Study NCT ID:
NCT01589926
Status:
TERMINATED
Last Update Posted:
2018-12-11
First Post:
2012-04-30
Brief Title:
Bi-Level Positive Airway Ventilation for Acute Chest Syndrome
Sponsor:
Albert Einstein College of Medicine
Organization:
Albert Einstein College of Medicine
Study Overview
Official Title:
Early Bi-Level Positive Airway Pressure BiPAP Ventilation for Acute Chest Syndrome ACS - a Double-Blind Randomized Controlled Pilot Study
Status:
TERMINATED
Status Verified Date:
2018-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Low enrollment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed Description:
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 breathingThe 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None