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Bi-Level Positive Airway Ventilation for Acute Chest Syndrome

This study is not yet open for participant recruitment.
Verified May 2012 by Albert Einstein College of Medicine of Yeshiva University
Sponsor:
Information provided by (Responsible Party):
Michael Roth, Albert Einstein College of Medicine of Yeshiva University
ClinicalTrials.gov Identifier:
NCT01589926
First received: April 30, 2012
Last updated: May 1, 2012
Last verified: May 2012
History of Changes
  Purpose

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.


Condition Intervention
Sickle Cell Anemia
Acute Chest Syndrome
 Procedure: Bi-level positive airway pressure
Procedure: Sham CPAP

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Early Bi-Level Positive Airway Pressure (BLPAP) Ventilation for Acute Chest Syndrome (ACS) - a Double-Blind Randomized Controlled Pilot Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Albert Einstein College of Medicine of Yeshiva University:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Rate of exchange transfusions. [ Time Frame: Diagnosis until discharge. Average 7 days. ] [ Designated as safety issue: No ]
  • Determine parent and patient acceptability of BLPAP administration in the setting of ACS. [ Time Frame: Upon completion of intervention at 48hrs. ] [ Designated as safety issue: No ]
  • Rate of PCCU transfers. [ Time Frame: Diagnosis until discharge. Average 7 days. ] [ Designated as safety issue: No ]
  • Difference in respiratory rate. [ Time Frame: 48hrs after intitiation of treatment. ] [ Designated as safety issue: No ]
  • Difference in pulmonary function tests. [ Time Frame: 48hrs after intitiation of treatment. ] [ Designated as safety issue: No ]
  • Difference in mean SpO2 recording during sleep. [ Time Frame: From initiation of treatment to 48hrs. ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: July 2012
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Bi-level Positive Airway Pressure
BLPAP initiated for at least 16 hours per day for a minimum of 48hrs.
 Procedure: Bi-level positive airway pressure
BLPAP initiated for at least 16 hours per day for a minimum of 48hrs.
Sham Comparator: Sham CPAP
Physiologic CPAP initiated for at least 16 hours per day for a minimum of 48hrs.
 Procedure: Sham CPAP
Sham CPAP initiated for at least 16 hours per day for a minimum of 48hrs.

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 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.

  Eligibility

Ages Eligible for Study:   4 Years to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Hemoglobin SS, SC, SB0thal or SBthal Ages ≥ 4-21 years old Patients are admitted to the hematology oncology inpatient service and have been enrolled and consented in the study.

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01589926

Contacts
Contact: Michael E Roth, MD 718 741 2342 mroth@montefiore.org

Locations
United States, New York
Children's Hospital @ Montefiore Not yet recruiting
Bronx, New York, United States, 10467
Contact: Michael E Roth, MD            
Sponsors and Collaborators
Albert Einstein College of Medicine of Yeshiva University
Investigators
Principal Investigator: Deepa Manwani, MD Albert Einstein College of Medicine of Yeshiva University
Principal Investigator: Michael E Roth, MD Albert Einstein College of Medicine of Yeshiva University
Study Director: Kerry Morrone, MD Albert Einstein College of Medicine of Yeshiva University
Principal Investigator: Hiren Muzumdar, MD Albert Einstein College of Medicine of Yeshiva University
Principal Investigator: Ranaan Arens, MD Albert Einstein College of Medicine of Yeshiva University
  More Information

No publications provided

Responsible Party: Michael Roth, Assistant Professor of Pediatrics, Albert Einstein College of Medicine of Yeshiva University
ClinicalTrials.gov Identifier: NCT01589926     History of Changes
Other Study ID Numbers: NCT01532001
Study First Received: April 30, 2012
Last Updated: May 1, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Anemia
Anemia, Sickle Cell
Acute Chest Syndrome
Hematologic Diseases
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
 Hemoglobinopathies
Genetic Diseases, Inborn
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders

ClinicalTrials.gov processed this record on June 18, 2013