AtelectasisPhase 4NCT02168387
Efficacy of Percussive Ventilation Therapy (MetaNeb ®) Compared With Mucolytic Agents for Atelectasis in the Mechanically Ventilated Pediatric Patient
A Phase 4 study testing continuous high frequency oscillator (CHFO), Acetylcysteine and dornase alfa in people with Atelectasis, run by Duke University.
Trial summary
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. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Atelectasis
- What is being tested?
- continuous high frequency oscillator (CHFO), Acetylcysteine and dornase alfa
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- No sites listed yet
- Study dates
- Dec 2010to Jul 2012
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Informed consent from parent or legal guardian.
- Age < 18 years and admitted to the PICU or PCICU.
- Conventionally ventilated.
- Mucolytics are being initiated by clinical team for treatment of atelectasis.
- Endotracheal tube ≥ 3.5 mm internal diameter.
Who cannot join
- Receiving chronic mucolytic or continuous high frequency oscillation therapy.
- Clinically significant pleural effusion.
- Status post cardiothoracic surgery with open chest.
- Pneumothorax.
- Pulmonary hemorrhage.
- Escalating doses of vasoactive agents (i.e. dopamine or epinephrine).
About this study
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.
Read the detailed description
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.
- Conditions
- Atelectasis
- Being tested
- continuous high frequency oscillator (CHFO), Acetylcysteine, dornase alfa
- Keywords
- atelectasis, continuous high frequency oscillator, acetylcysteine, dornase alfa
- Medical subject headings
- Pulmonary Atelectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
continuous high frequency oscillator (CHFO)Device
AcetylcysteineDrug
dornase alfaDrug
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: continuous high frequency oscillator (CHFO) |
| 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. Receives: Drug: Acetylcysteine; Drug: dornase alfa |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
- Partial collapse of 1 segment or lobe
- Partial collapse of ≥ 2 segments or lobes
- Complete collapse of 1 segment or lobe
- Complete collapse of ≥ 2 segments or lobes
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).
Measured: after 48 hours of therapy
Secondary outcomes (2)
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.
Measured: baseline and 48 hours
Change in Quantity and Quality of Suctioned Mucus
Measured: baseline and 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2014 (estimated)
- Study startDec 2010
- Primary completionMay 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for AtelectasisStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ira Cheifetz, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02168387
- Sponsor's protocol ID
- Pro00026503
- Status last verified
- Mar 2015
- First submitted
- 18 Jun 2014
- Last updated
- 3 Mar 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Percussive Ventilation Therapy (MetaNeb ®) Compared With Mucolytic Agents for Atelectasis in the Mechanically Ventilated Pediatric Patient
- ClinicalTrials.gov ID
- NCT02168387
- Acronym / sponsor ID
- Pro00026503
- Conditions
- Atelectasis
- Keywords
- atelectasis, continuous high frequency oscillator, acetylcysteine, dornase alfa
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- Dec 2010
- Primary completion
- May 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 20 Jun 2014 (estimated)
- Results
- Posted 3 Mar 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| continuous high frequency oscillator (CHFO) | Active comparator | Device: 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. |
| medication | Active comparator | Drug: Acetylcysteine, Drug: dornase alfaSubjects 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. |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Informed consent from parent or legal guardian.
- Age < 18 years and admitted to the PICU or PCICU.
- Conventionally ventilated.
- Mucolytics are being initiated by clinical team for treatment of atelectasis.
- Endotracheal tube ≥ 3.5 mm internal diameter.
Key exclusion criteria (6 listed)
- Receiving chronic mucolytic or continuous high frequency oscillation therapy.
- Clinically significant pleural effusion.
- Status post cardiothoracic surgery with open chest.
- Pneumothorax.
- Pulmonary hemorrhage.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| continuous high frequency oscillator (CHFO) | Device | continuous high frequency oscillator (CHFO) |
| Acetylcysteine | Drug | medication |
| dornase alfa | Drug | medication |
Primary outcome
Improvement of Atelectasis
Time frame: after 48 hours of therapy
An atelectasis score (AS), as published by Deakins, et al. 2002, was assigned to each radiograph as follows: 0 Complete resolution of collapse 1. Partial collapse of 1 segment or lobe 2. Partial collapse of ≥ 2 segments or lobes 3. Complete collapse of 1 segment or lobe 4. Complete collapse of ≥ 2 segments or lobes 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).
2 secondary outcomes
Change in Capnography (Vd/Vt)
Time frame: baseline and 48 hours
Change in Quantity and Quality of Suctioned Mucus
Time frame: baseline and 48 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Atelectasis
Recruiting
Comparing Surfactant Administration Through Supraglottic Airway and Thin Catheter for Preterm Infants
Surfactant, Respiratory Distress Syndrome (Neonatal)
Active, not recruiting
Stepwise PEEP vs Sustained Inflation in Bariatric Surgery Patients
Recruitment, Bariatric Surgery Candidate
Not yet recruiting
Bedside Assessment of Right Ventricular Output Lying in Prone Or Supine
Right Ventricular Function, Prone Position
Recruiting
Bronchoscopic Airway Clearance for Improving Lung Aeration in Mechanically Ventilated Patients With Atelectasis
Atelectasis, Mechanical Ventilation
Not yet recruitingObservational study
Chest Ultrasound as Diagnostic and Prognostic Tool in Neonatal RDS
Respiratory Distress Syndrome, Newborn, Neonatal Respiratory Distress
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ira Cheifetz, MD principal investigator
Duke University
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing continuous high frequency oscillator (CHFO), Acetylcysteine and dornase alfa in people with Atelectasis, run by Duke University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Mar 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement of Atelectasis (time frame: after 48 hours of therapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2015.