Bi-Level Positive Airway Ventilation for Acute Chest Syndrome

NCT01589926 | Terminated Results DMC FDA Device

• 1 other identifier: 12-04-139
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

Sickle Cell Anemia; Acute Chest Syndrome

Outcome Measures

Primary Outcomes (1)

• Length of Stay as Measured by the Time From Initial Diagnosis of ACS Until Meeting Discharge Criteria.

  Length of stay as measured by the time from initial diagnosis of ACS until meeting discharge criteria. It is anticipated length of stay will correlate to efficacy of treatment: shorter stay is theorized to indicate more efficient treatment.

  From diagnosis of ACS until meeting discharge criteria- Average 7 days.

Secondary Outcomes (6)

• Rate of Exchange Transfusions.

  Diagnosis until discharge. Average 7 days.

• Determine Parent and Patient Acceptability of BLPAP Administration in the Setting of ACS.

  Upon completion of intervention at 48hrs.

• Rate of PCCU Transfers.

  Diagnosis until discharge. Average 7 days.

• Difference in Respiratory Rate.

  48hrs after initiation of treatment

• Difference in Pulmonary Function Tests.

  48hrs after initiation of treatment

Study Arms (2)

Bi-level Positive Airway Pressure Device

EXPERIMENTAL

BiPAP initiated for at least 16 hours per day for a minimum of 48hrs.

Device: Bi-level positive airway pressure device

Sham CPAP

SHAM COMPARATOR

Physiologic continuous positive airway pressure (CPAP) initiated for at least 16 hours per day for a minimum of 48hrs.

Device: Sham CPAP

Interventions

Bi-level positive airway pressure device DEVICE

BiPAP initiated for at least 16 hours per day for a minimum of 48hrs.

Bi-level Positive Airway Pressure Device

Sham CPAP DEVICE

Sham CPAP initiated for at least 16 hours per day for a minimum of 48hrs.

Sham CPAP

Eligibility Criteria

• Age: 4 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

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

Sponsors & Collaborators

• Albert Einstein College of Medicine: lead

Study Sites (1)

Children's Hospital @ Montefiore

The Bronx, New York, 10467, United States

Location

MeSH Terms

Conditions

Anemia, Sickle Cell; Acute Chest Syndrome

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Results Point of Contact

• Title: Kerry Morrone, MD, Asst Prof of Pediatrics
• Organization: Children's Hospital at Montefiore

kmorrone@montefiore.org

718-741-2342

Study Officials

• Deepa Manwani, MD

  Albert Einstein College of Medicine

  PRINCIPAL INVESTIGATOR

• Michael E Roth, MD

  Albert Einstein College of Medicine

  PRINCIPAL INVESTIGATOR

• Kerry Morrone, MD

  Albert Einstein College of Medicine

  STUDY DIRECTOR

• Hiren Muzumdar, MD

  Albert Einstein College of Medicine

  PRINCIPAL INVESTIGATOR

• Ranaan Arens, MD

  Albert Einstein College of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Pediatrics

Study Record Dates

• First Submitted: April 30, 2012
• First Posted: May 2, 2012
• Study Start: July 1, 2012
• Primary Completion: September 8, 2016
• Study Completion: September 8, 2016
• Last Updated: December 11, 2018
• Results First Posted: December 11, 2018

Record last verified: 2018-11

Locations

US (1)