Back to resultsEvaluation of BAL Procedure With Ambu aScope 3 Large in Patients in an ICU Setting
Primary Purpose
Atelectasis, Bronchoscopy
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Bronchoscopic procedure
Sponsored by
About this trial
This is an interventional treatment trial for Atelectasis
Eligibility Criteria
Inclusion Criteria:
- Patients ≥18 years
- Clinical indication and eligible for a BAL procedure, as judged by the investigator
- Patients being admitted in the ICU at the investigational centre
- Provision of signed IC by subject, or subject's legal representative e.g. next of kin
Exclusion Criteria:
- Patients where BAL treatment cannot be clinically justified, judged by the investigator
- ETT >7 mm and ≤8.5 mm in diameter
- Participating in other interventional clinical investigations or have previously participated in this investigation
Sites / Locations
- University of Chicago Medicine
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
aScope 3 Large
Arm Description
Bronchoscopic procedure
Outcomes
Primary Outcome Measures
Improvement in Oxygenation (PaO2/FiO2 Ratio) After a BAL Treatment
Resolution of atelectasis measured by improvement in oxygenation after a bronchoscopic procedure (bronchoalveolar lavage treatment). PaO2/FiO2 ratio will be compared between baseline and 4 hourst post the BAL procedure.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03581474
Brief Title
Evaluation of BAL Procedure With Ambu aScope 3 Large in Patients in an ICU Setting
Official Title
Evaluation of a Bronchoalveolar Lavage Procedure With a Flexible Disposable Bronchoscope, Ambu aScope 3 Large in Patients in an Intensive Care Unit Setting
Study Type
Interventional
2. Study Status
Record Verification Date
June 2018
Overall Recruitment Status
Terminated
Why Stopped
Slow recruitment
Study Start Date
September 28, 2017 (Actual)
Primary Completion Date
July 3, 2018 (Actual)
Study Completion Date
July 3, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ambu A/S
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
An Investigation to determine the single-use scope's ability to suction secretion from the lungs to resolve the collapse of the lung.
Detailed Description
The purpose of this investigation it to determine the single-use scope's ability to suction secretion from the lungs to resolve the collapse of the lung. The hypothesis is that aScope 3 Large is able to manage the secretion and thereby facilitating the resolution of secretion in the lung.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atelectasis, Bronchoscopy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
aScope 3 Large
Arm Type
Other
Arm Description
Bronchoscopic procedure
Intervention Type
Device
Intervention Name(s)
Bronchoscopic procedure
Intervention Description
Single-use flexible bronchoscope aScope 3 Large
Primary Outcome Measure Information:
Title
Improvement in Oxygenation (PaO2/FiO2 Ratio) After a BAL Treatment
Description
Resolution of atelectasis measured by improvement in oxygenation after a bronchoscopic procedure (bronchoalveolar lavage treatment). PaO2/FiO2 ratio will be compared between baseline and 4 hourst post the BAL procedure.
Time Frame
4 hours after procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients ≥18 years
Clinical indication and eligible for a BAL procedure, as judged by the investigator
Patients being admitted in the ICU at the investigational centre
Provision of signed IC by subject, or subject's legal representative e.g. next of kin
Exclusion Criteria:
Patients where BAL treatment cannot be clinically justified, judged by the investigator
ETT >7 mm and ≤8.5 mm in diameter
Participating in other interventional clinical investigations or have previously participated in this investigation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anna Charlotte Lundgaard
Organizational Affiliation
Ambu A/S
Official's Role
Study Chair
Facility Information:
Facility Name
University of Chicago Medicine
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Evaluation of BAL Procedure With Ambu aScope 3 Large in Patients in an ICU Setting
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