Clinical trial NCT02871258: MetaNeb® Chest X-ray Study
Official title: Evaluation of The MetaNeb® System to Reduce Atelectasis Assessed by Chest X-ray
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atelectasis
Lead sponsor: Baxter Healthcare Corporation
Sponsor class: INDUSTRY
First posted: 2016-08-18
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Chest X-ray Score at Day 2 (Approximately 48 Hours) After Initiation of Therapy With The MetaNeb® System.
timeFrame: Approximately 48 hours post-initiation of therapy with The MetaNeb® System.
Secondary outcomes:
measure: 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.
timeFrame: Approximately 24 hours and at Day 4, approximately 96 hours, or at discharge if discharge occurs before Day 4
measure: Chest X-ray Improvement Using a Comparative Scale (Comparing Baseline, Day 1, Day 2, and Day 4/Discharge).
timeFrame: Comparing baseline, Day 1, Day 2, and Day 4/discharge.
measure: Oxygenation Index (SpO2 /FiO2 Ratio).
timeFrame: Oxygenation Index (SpO2 /FiO2 ratio) at Baseline, Day 1 AM, Day 1 PM, Day 2 AM, Day 2 PM, and Day 4/early discharge
measure: Patient Reported Level of Dyspnea Assessed by Modified Borg Dyspnea Scale.
timeFrame: Patient reported level of dyspnea assessed by Modified Borg Dyspnea Scale on Baseline (Day 0), Day 1, and Day 2.
measure: Change in Patient Respiratory Status Assessed by Subjective Physician Respiratory Status Evaluation.
timeFrame: Respiratory status evaluation at time of enrollment and on Day 2
Other outcomes:
Locations:
city: Newport Beach
country: United States
facility: Hoag Memorial Hospital Presbyterian
state: California
Study officials:
affiliation: Hoag Memorial Hospital, Newport Beach, CA
name: Thomas Diamant, M.D., F.C.C.P
role: PRINCIPAL_INVESTIGATOR
References: