MetaNeb® Chest X-ray Study

NCT02871258 | Completed Results

• 1 other identifier: CR-RR2016- 001
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Atelectasis

Outcome Measures

Primary Outcomes (1)

• 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.,)

  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.

  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).

  Comparing baseline, Day 1, Day 2, and Day 4/discharge.

• Oxygenation Index (SpO2 /FiO2 Ratio).

  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 on Baseline (Day 0), Day 1, and Day 2.

• Change in Patient Respiratory Status Assessed by Subjective Physician Respiratory Status Evaluation.

  Respiratory status evaluation at time of enrollment and on Day 2

Study Arms (1)

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.

Device: The MetaNeb® System

Interventions

The MetaNeb® System DEVICE

The MetaNeb® System Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hill-Rom: lead

Study Sites (1)

Hoag Memorial Hospital Presbyterian

Newport Beach, California, 92658, United States

Location

MeSH Terms

Conditions

Pulmonary Atelectasis

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Baxter Clinical Trials Disclosure Call Center
• Organization: Baxter Healthcare

Global_CORP_ClinicalTrialsDisclosure@baxter.com

(224) 948-7359

Study Officials

• Thomas Diamant, M.D., F.C.C.P

  Hoag Memorial Hospital, Newport Beach, CA

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 14, 2016
• First Posted: August 18, 2016
• Study Start: September 1, 2016
• Primary Completion: August 17, 2017
• Study Completion: August 17, 2017
• Last Updated: September 24, 2024
• Results First Posted: September 24, 2024

Record last verified: 2024-08

Locations

US (1)