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The purpose of this study is to evaluate whether a therapy that uses a machine called a continuous high frequency oscillator (CHFO) is more successful at removing mucus than medications that thin out the mucus.
Both of these therapies (CHFO and medication) are currently used in the Pediatric Intensive Care Unit and Pediatric Cardiac Intensive Care Unit. This research study is being done because the investigator is trying to learn if the mechanical removal of mucus with CHFO will effectively re-inflate the collapsed area of lung. Specifically, the study team will determine if CHFO can improve lung inflation with the same or improved vital signs (heart rate, blood pressure, and breathing rate), and the same or improved ability to help the lungs move oxygen into the blood.
One of the problems with the medication approach is that while it thins out the mucus, actual removal from the lung requires a strong cough which is difficult for infants and children to produce when they are sedated and on a ventilator (breathing machine).
Thus, the aim of this research study is to test whether children with atelectasis on a ventilator are more likely to improve with mechanical removal of their mucus with the CHFO as compared with medications that thin out the mucus. CHFO and all the medications used in this study are part of the standard of care for atelectesis. However, there is no information on which combination works best and no one agrees that one approach is more effective than another. Usually patients are evaluated for 48 hours after starting treatment, before adding or making any changes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| continuous high frequency oscillator (CHFO) | Active Comparator | Subjects randomized to receive therapy with the CHFO will receive a 20 minute treatment every 6 hours for 48 hours. |
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| medication | Active Comparator | Subjects randomized to receive the medications will receive acetylcysteine and dornase alfa, two medications frequently used in the treatment of atelectasis. The medications will alternate every 6 hours for 48 hours. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| continuous high frequency oscillator (CHFO) | Device |
| ||
| Acetylcysteine |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement of Atelectasis | An atelectasis score (AS), as published by Deakins, et al. 2002, was assigned to each radiograph as follows: 0 Complete resolution of collapse
In the event of inter-rater disagreement, the scores were averaged. Improvement was defined as any decrease in AS ≥ 0.5. Worsening was defined as an increase in AS ≥ 0.5 or escalation of respiratory support modality (i.e. high frequency ventilation). | after 48 hours of therapy |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Capnography (Vd/Vt) | The deadspace-to-tidal volume (Vd/Vt) ratio is a parameter that is measured in mechanically ventilated patients as a way to assess the severity of gas exchange impairment and to assist in determining whether a patient is ready to be weaned from the ventilator. The change from baseline was measured at 48 hours, with a decreasing ratio indicating improvement. | baseline and 48 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ira Cheifetz, MD | Duke University | Principal Investigator |
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All mechanically ventilated patients 0-17 years of age admitted to the Pediatric Intensive Care Unit (PICU) and Pediatric Cardiac Intensive Care Unit (PCICU) from January 2011 to March 2012 with radiographic evidence of atelectasis for which mucolytics or CHFO therapy were being initiated by the patient care team were screened for enrollment.
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| ID | Title | Description |
|---|---|---|
| FG000 | Medication | Subjects randomized to receive the medications will receive acetylcysteine and dornase alfa, two medications frequently used in the treatment of atelectasis. The medications will alternate every 6 hours for 48 hours. Acetylcysteine dornase alfa |
| FG001 | Continuous High Frequency Oscillator (CHFO) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Drug |
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| dornase alfa | Drug |
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| Change in Quantity and Quality of Suctioned Mucus | baseline and 48 hours |
Subjects randomized to receive therapy with the CHFO will receive a 20 minute treatment every 6 hours for 48 hours. continuous high frequency oscillator (CHFO) |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Medication | Subjects randomized to receive the medications will receive acetylcysteine and dornase alfa, two medications frequently used in the treatment of atelectasis. The medications will alternate every 6 hours for 48 hours. |
| BG001 | Continuous High Frequency Oscillator (CHFO) | Subjects randomized to receive therapy with the CHFO will receive a 20 minute treatment every 6 hours for 48 hours. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number | participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Improvement of Atelectasis | An atelectasis score (AS), as published by Deakins, et al. 2002, was assigned to each radiograph as follows: 0 Complete resolution of collapse
In the event of inter-rater disagreement, the scores were averaged. Improvement was defined as any decrease in AS ≥ 0.5. Worsening was defined as an increase in AS ≥ 0.5 or escalation of respiratory support modality (i.e. high frequency ventilation). | Posted | Number | participants | after 48 hours of therapy |
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| Secondary | Change in Capnography (Vd/Vt) | The deadspace-to-tidal volume (Vd/Vt) ratio is a parameter that is measured in mechanically ventilated patients as a way to assess the severity of gas exchange impairment and to assist in determining whether a patient is ready to be weaned from the ventilator. The change from baseline was measured at 48 hours, with a decreasing ratio indicating improvement. | Posted | Mean | Standard Deviation | ratio | baseline and 48 hours |
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| Secondary | Change in Quantity and Quality of Suctioned Mucus | These data were not obtained due to technical difficulties. | Posted | baseline and 48 hours |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Medication | Subjects randomized to receive the medications will receive acetylcysteine and dornase alfa, two medications frequently used in the treatment of atelectasis. The medications will alternate every 6 hours for 48 hours. | 1 | 20 | 0 | 20 | ||
| EG001 | Continuous High Frequency Oscillator (CHFO) | Subjects randomized to receive therapy with the CHFO will receive a 20 minute treatment every 6 hours for 48 hours. | 0 | 19 | 0 | 19 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| death due to underlying disease | General disorders |
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Small sample size in a single center study. Children who were extubated prior to the end of the study were not accounted for, as this was not a primary endpoint.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ira M. Cheifetz, MD, FCCM, FAARC | Duke University Medical Center | 919-681-4080 | ira.cheifetz@dm.duke.edu |
| ID | Term |
|---|---|
| D001261 | Pulmonary Atelectasis |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D000111 | Acetylcysteine |
| C568813 | dornase alfa |
| ID | Term |
|---|---|
| D003545 | Cysteine |
| D000603 | Amino Acids, Sulfur |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
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| Male |
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| No change in 48 hr |
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