Clinical Trial: Bi-Level Positive Airway Ventilation for Acute Chest Syndrome

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Early Bi-Level Positive Airway Pressure (BLPAP) Ventilation for Acute Chest Syndrome (ACS) - a Double-Blind Randomized Controlled Pilot Study

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 (BLPAP) is a device that blows air into a patients lungs via a mask that covers the nose. Our goal is to determine whether giving children BLPAP 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 BLPAP will have milder clinical courses resulting in shorter hospital stays and fewer transfers to the intensive care unit and exchange transfusions.

Detailed Summary:

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.

Our goal is to perform a prospective double blind randomized control trial to investigate if early initiation of effective BLPAP in addition to providing standard clinical care for ACS alters the clinical course of these patients vs. sham BLPAP and standard clinical care. We hypothesize that patients receiving effective BLPAP will have milder clinical courses resulting in shorter hospital stays and fewer transfers to PCCU and exchange transfusions.


Sponsor: Albert Einstein College of Medicine, Inc.

Current Primary Outcome: Length of stay as measured by the time from initial diagnosis of ACS until meeting discharge criteria. [ Time Frame: From diagnosis of ACS until meeting discharge criteria- Average 7 days. ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Rate of exchange transfusions. [ Time Frame: Diagnosis until discharge. Average 7 days. ]
  • Determine parent and patient acceptability of BLPAP administration in the setting of ACS. [ Time Frame: Upon completion of intervention at 48hrs. ]
  • Rate of PCCU transfers. [ Time Frame: Diagnosis until discharge. Average 7 days. ]
  • Difference in respiratory rate. [ Time Frame: 48hrs after intitiation of treatment. ]
  • Difference in pulmonary function tests. [ Time Frame: 48hrs after intitiation of treatment. ]
  • Difference in mean SpO2 recording during sleep. [ Time Frame: From initiation of treatment to 48hrs. ]


Original Secondary Outcome: Same as current

Information By: Albert Einstein College of Medicine, Inc.

Dates:
Date Received: April 30, 2012
Date Started: July 2012
Date Completion: July 2014
Last Updated: May 1, 2012
Last Verified: May 2012