MetaNeb® Chest X-ray Study

Atelectasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02871258
• Other study ID #: CR-RR2016- 001
• Status: Completed
• Phase: N/A
• Start date: September 2016
• Est. completion date: August 17, 2017

Study information

• Verified date: February 2024
• Source: Baxter Healthcare Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: August 17, 2017
• Est. primary completion date: August 17, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atelectasis
• Pulmonary Atelectasis

Intervention

Device:
• The MetaNeb® System

Locations

Country	Name	City	State
United States	Hoag Memorial Hospital Presbyterian	Newport Beach	California

Sponsors (1)

Lead Sponsor	Collaborator
Hill-Rom

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Chest x-ray score improvement at Day 2 (approximately 48) hours after initiation of therapy with The MetaNeb® System.	Chest x-ray score improvement 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. The Kelly score for each of the chest x-rays was assessed by blinded reader. The baseline chest x-ray for each subject was the qualifying x-ray that determined the presence of significant atelectasis.	Approximately 48 hours post-initiation of therapy with The MetaNeb® System.
Secondary	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.	Chest x-ray score improvement at Day 1 (approximately 24 hours) and at Day 4 (approximately 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.	Approximately 24 hours and at Day 4, approximately 96 hours, or at discharge if discharge occurs before Day 4
Secondary	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).	Comparing baseline, Day 1, Day 2, and Day 4/discharge.
Secondary	Oxygenation index (SpO2 /FiO2 ratio).	Oxygenation Index (SpO2 /FiO2 ratio) at Day 1, Day 2, and day 4/discharge compared to baseline.	Oxygenation Index (SpO2 /FiO2 ratio) at Day 1, Day 2, and day 4/discharge
Secondary	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.	Patient reported level of dyspnea assessed by Modified Borg Dyspnea Scale on Day 0, Day 1, and Day 2.
Secondary	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	Respiratory status evaluation at time of enrollment and on Day 2