AtelectasisNCT02871258

MetaNeb® Chest X-ray Study

A study testing The MetaNeb® System in people with Atelectasis, run by Hill-Rom at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Atelectasis
What is being tested?: The MetaNeb® System
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 8 participants
Where: 1 siteUnited States
Study dates: Sep 2016to 17 Aug 2017
Phase: Interventional
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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Post-surgical (thoracic, cardiac or abdominal surgery)
Age ≥ 18 years
Significant atelectasis by chest x-ray
Patient meets indication for therapy intervention as defined by Recruitment and Airway Clearance Protocol (Respiratory Department Policy and Procedure)
Signed informed consent

Who cannot join

Cause of atelectasis suspected to be infectious or solid mass
Requirement for mechanical ventilation
Requirement for chronic supplemental oxygen
Hemodynamically unstable, as defined by need for vasopressor therapy
Anticipated need for mechanical ventilation or other poor clinical outcome, unrelated to atelectasis or secretion retention
Contraindication to MetaNeb® therapy (untreated tension pneumothorax)
Inability to perform MetaNeb® therapy using a mouthpiece
Anticipated hospital discharge within 24 hours

Trial locations and contacts

1 site in 1 country.

United States1 site

Hoag Memorial Hospital Presbyterian
Newport Beach, California, 92658

Other trials in United States

About this study

Official title: Evaluation of The MetaNeb® System to Reduce Atelectasis Assessed by Chest X-ray

To study objective is to evaluate the impact of use of The MetaNeb® System in clearance of atelectasis, as demonstrated by improvement in chest x-rays. This is a a non-randomized open label study, with all subjects receiving treatment with The MetaNeb® System. Subjects who qualify for enrollment in the study will receive therapy with The MetaNeb® System following the labeled instructions for the device. Details of the treatment including duration and frequency will be defined in treatment procedures.

Read the detailed description

Study Population:

Post-surgical (thoracic, cardiac or abdominal surgery) non-mechanically ventilated patients with significant atelectasis as documented by chest x-ray results.

Duration of treatment:

Duration of treatment with The MetaNeb® System will be a minimum of 48 hours, or until the subject is discharged from the hospital (if discharge is earlier). Enrolled subjects will remain in the study through Day 4 or until the subject is discharged from the hospital, whichever occurs sooner.

Conditions: Atelectasis
Being tested: The MetaNeb® System
Medical subject headings: Pulmonary Atelectasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

The MetaNeb® SystemDevice

Study groups in NCT02871258
Study group	Role	What they receive
The MetaNeb® System Treatment	Other	Treatment with The MetaNeb® System for a minimum of 48 hours, or until hospital discharge, if discharge is within 48 hours from initial treatment. Receives: Device: The MetaNeb® System

What is being measured

The primary outcome is the main question the study is designed to answer.

Chest X-ray Score at Day 2 (Approximately 48 Hours) After Initiation of Therapy With The MetaNeb® System.
Chest x-rays were scored using the Kelly scoring system to assess the presence of atelectasis on Day 2, after initiation of therapy with The MetaNeb® System. Scores for chest x-rays at Day 2 were compared to the scores for chest x-rays taken at baseline.
3 of the 8 subjects did not have measurable level of atelectasis at baseline and were excluded from the Kelly Score analyses.
A score of 0 represents normal clear lungs whilst a score of 4 represent the whole lung is consolidated. A blinded reader scored each lung separately based on the Kelly Score scale. The Kelly scores from the left and right lung of each subject were averaged to get a mean score for each subject. Kelly Score ranges are as follows: 0 Normal; 1 Linear atelectasis; 1.25 a: one third of hemidiaphragm; 1.50b: two thirds of hemidiaphragm;1.75c: all of one hemidiaphragm; 2 Lobar consolidation; 3 Lobar collapse; 4 Bronchial consolidation (whole lung, bronchopneumonia etc.,)
Measured: Approximately 48 hours post-initiation of therapy with The MetaNeb® System.

Secondary outcomes (5)

Chest X-ray Assessed by Kelly Atelectasis Score at Day 1 (Approximately 24 Hours) and Day 4 (Approximately 96 Hours, or at Discharge if Discharge Occurs Before Day 4), Compared to Baseline.
Mean chest x-ray score change for both lungs at Day 1 (approx. 24 hours) and at Day 4 (approx. 96 hours or at discharge, if discharge occurs before Day 4) after initiation of therapy with The MetaNeb® System. Scored using the Kelly score, as described above, to assess the presence of atelectasis. 3 of the 8 subjects did not have measurable level of atelectasis at baseline and were excluded from the Kelly Score analyses. A score of 0 represents normal clear lungs whilst a score 4 represent the whole lung is consolidated. A blinded reader scored each lung separately based on the Kelly Score scale. The Kelly scores from the left and right lung of each subject were averaged to get a mean score for each subject. Kelly Score ranges are as follows: 0 Normal; 1 Linear atelectasis; 1.25 a: one third of hemidiaphragm; 1.50b: two thirds of hemidiaphragm;1.75c: all of one hemidiaphragm; 2 Lobar consolidation; 3 Lobar collapse; 4 Bronchial consolidation (whole lung, bronchopneumonia etc.,)
Measured: Approximately 24 hours and at Day 4, approximately 96 hours, or at discharge if discharge occurs before Day 4
Chest X-ray Improvement Using a Comparative Scale (Comparing Baseline, Day 1, Day 2, and Day 4/Discharge).
Chest x-ray improvement using a comparative scale after a minimum of forty-eight (48) hours of therapy with The MetaNeb® System. Chest x-ray improvement assessed using comparative scale for baseline, Day 1, Day 2, and Day 4/discharge. Four chest x-rays for each enrolled subject (baseline, Day 1, Day 2, and day 4/discharge), with date and time masked, were sent to the radiologist for comparison.
The radiologist ranked the four x-rays as 1, 2, 3, or 4 (1 = least atelectasis, 4 = most atelectasis).
*Subjects 3 and 4 were discharged on Day 2, and therefore the Day 2 and Day 4/Early Discharge Chest X-rays are one in the same for the purposes of the analysis
Measured: Comparing baseline, Day 1, Day 2, and Day 4/discharge.
Oxygenation Index (SpO2 /FiO2 Ratio).
Oxygenation Index (SpO2 /FiO2 ratio) at Day 1, Day 2, and day 4/discharge compared to baseline.
SPO2/FiO2 is available for only the 6 subjects that received oxygen during the study. Subjects 3 and 4 did not receive oxygen and no SPO2/FiO2 ratios were calculated.
higher SPO2/FiO2 value indicates better oxygenation.
Measured: Oxygenation Index (SpO2 /FiO2 ratio) at Baseline, Day 1 AM, Day 1 PM, Day 2 AM, Day 2 PM, and Day 4/early discharge
Patient Reported Level of Dyspnea Assessed by Modified Borg Dyspnea Scale.
Patient reported level of dyspnea (assessed by Modified Borg Dyspnea Scale).This is a scale that asks patients to rate the difficulty of their breathing. It starts at number zero (0) where the breathing is causing the patient no difficulty at all, and progresses through to number ten (10) where the patients' breathing difficulty is maximal.
0: Nothing at all; 0.5: Very, very slight (just noticeable); 1: Very slight; 2: Slight; 3: Moderate; 4: Somewhat severe; 5: Severe; 7: Very severe; 9: Very, very severe (almost maximal); 10: Maximal.
Measured: Patient reported level of dyspnea assessed by Modified Borg Dyspnea Scale on Baseline (Day 0), Day 1, and Day 2.
Change in Patient Respiratory Status Assessed by Subjective Physician Respiratory Status Evaluation.
Change in patient respiratory status (Respiratory Status Evaluation). Physician observation and evaluation of patient respiratory status at time of enrollment (baseline) and on Day 2 to assess if worse, unchanged, or improved through:
- Lung assessment: percussion
- Lung assessment: Auscultation
- Cough assessment
- Secretion assessment
- oxygenation
- Work of breathing
- Other observations: General appearance, mental acuity, respiratory pain
Measured: Respiratory status evaluation at time of enrollment and on Day 2

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 201617 Aug 2017

First posted18 Aug 2016 (estimated)
Study startSep 2016
Primary completion17 Aug 2017
Study completion17 Aug 2017

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.
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 N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 8 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02871258
Sponsor's protocol ID: CR-RR2016- 001
Status last verified: Aug 2024
First submitted: 14 Aug 2016
Last updated: 24 Sep 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Atelectasis trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of The MetaNeb® System to Reduce Atelectasis Assessed by Chest X-ray
ClinicalTrials.gov ID: NCT02871258
Acronym / sponsor ID: CR-RR2016- 001
Conditions: Atelectasis
Study type: Interventional
Recruitment status: Completed
Enrolment: 8 participants (actual)
Lead sponsor: Hill-RomIndustry (pharma, biotech, devices)
Study start: Sep 2016
Primary completion: 17 Aug 2017 (actual)
Study completion: 17 Aug 2017 (actual)
First posted: 18 Aug 2016 (estimated)
Results: Posted 24 Sep 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study Population:

Post-surgical (thoracic, cardiac or abdominal surgery) non-mechanically ventilated patients with significant atelectasis as documented by chest x-ray results.

Duration of treatment:

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
The MetaNeb® System Treatment	Other	Device: The MetaNeb® SystemTreatment with The MetaNeb® System for a minimum of 48 hours, or until hospital discharge, if discharge is within 48 hours from initial treatment.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Post-surgical (thoracic, cardiac or abdominal surgery)
Age ≥ 18 years
Significant atelectasis by chest x-ray
Patient meets indication for therapy intervention as defined by Recruitment and Airway Clearance Protocol (Respiratory Department Policy and Procedure)
Signed informed consent

Key exclusion criteria (8 listed)

Cause of atelectasis suspected to be infectious or solid mass
Requirement for mechanical ventilation
Requirement for chronic supplemental oxygen
Hemodynamically unstable, as defined by need for vasopressor therapy
Anticipated need for mechanical ventilation or other poor clinical outcome, unrelated to atelectasis or secretion retention

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
The MetaNeb® System	Device	The MetaNeb® System Treatment

Primary outcome

Chest X-ray Score at Day 2 (Approximately 48 Hours) After Initiation of Therapy With The MetaNeb® System.
Time frame: Approximately 48 hours post-initiation of therapy with The MetaNeb® System.
Chest x-rays were scored using the Kelly scoring system to assess the presence of atelectasis on Day 2, after initiation of therapy with The MetaNeb® System. Scores for chest x-rays at Day 2 were compared to the scores for chest x-rays taken at baseline. 3 of the 8 subjects did not have measurable level of atelectasis at baseline and were excluded from the Kelly Score analyses. A score of 0 represents normal clear lungs whilst a score of 4 represent the whole lung is consolidated. A blinded reader scored each lung separately based on the Kelly Score scale. The Kelly scores from the left and right lung of each subject were averaged to get a mean score for each subject. Kelly Score ranges are as follows: 0 Normal; 1 Linear atelectasis; 1.25 a: one third of hemidiaphragm; 1.50b: two thirds of hemidiaphragm;1.75c: all of one hemidiaphragm; 2 Lobar consolidation; 3 Lobar collapse; 4 Bronchial consolidation (whole lung, bronchopneumonia etc.,)

5 secondary outcomes

Chest X-ray Assessed by Kelly Atelectasis Score at Day 1 (Approximately 24 Hours) and Day 4 (Approximately 96 Hours, or at Discharge if Discharge Occurs Before Day 4), Compared to Baseline.
Time frame: Approximately 24 hours and at Day 4, approximately 96 hours, or at discharge if discharge occurs before Day 4
Chest X-ray Improvement Using a Comparative Scale (Comparing Baseline, Day 1, Day 2, and Day 4/Discharge).
Time frame: Comparing baseline, Day 1, Day 2, and Day 4/discharge.
Oxygenation Index (SpO2 /FiO2 Ratio).
Time frame: Oxygenation Index (SpO2 /FiO2 ratio) at Baseline, Day 1 AM, Day 1 PM, Day 2 AM, Day 2 PM, and Day 4/early discharge
Patient Reported Level of Dyspnea Assessed by Modified Borg Dyspnea Scale.
Time frame: Patient reported level of dyspnea assessed by Modified Borg Dyspnea Scale on Baseline (Day 0), Day 1, and Day 2.
Change in Patient Respiratory Status Assessed by Subjective Physician Respiratory Status Evaluation.
Time frame: Respiratory status evaluation at time of enrollment and on Day 2

Results and safety

Results posted to the registry on 24 Sep 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
The MetaNeb® System Treatment	8	8

Primary outcome: Chest X-ray Score at Day 2 (Approximately 48 Hours) After Initiation of Therapy With The MetaNeb® System.

Time frame: Approximately 48 hours post-initiation of therapy with The MetaNeb® System.. Mean (Standard Deviation). Unit: scores on a scale

Measure	The MetaNeb® System Treatment n = 5
Subject 2 : Baseline Score	1.63 (0.18)
Subject 2 : Day 2 Score	1.75 (0.35)
Subject 4 : Baseline Score	1.25 (0.00)
Subject 4 : Day 2 Score	1.13 (0.18)
Subject 5 : Baseline Score	1.13 (0.18)
Subject 5 : Day 2 Score	1.25 (0.0)
Subject 6 : Baseline Score	0.75 (1.06)
Subject 6 : Day 2 Score	1.25 (0.35)

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: 4 Days. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
The MetaNeb® System Treatment	0 of 8 (0%)	0 of 8 (0%)	0 of 8

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

Thomas Diamant, M.D., F.C.C.P principal investigator

Hoag Memorial Hospital, Newport Beach, CA

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing The MetaNeb® System in people with Atelectasis, run by Hill-Rom at 1 site in United States.

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 8 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 24 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

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.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Sep 2024). 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?

Chest X-ray Score at Day 2 (Approximately 48 Hours) After Initiation of Therapy With The MetaNeb® System. (time frame: Approximately 48 hours post-initiation of therapy with The MetaNeb® System.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02871258.

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 24 Sep 2024.