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NCT03581474 Clinical Trial

Evaluation of BAL Procedure With Ambu aScope 3 Large in Patients in an ICU Setting

Atelectasis Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT03581474
Other study ID # CIS-001
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date September 28, 2017
Est. completion date July 3, 2018

Study information
Verified date June 2018
Source Ambu A/S
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

An Investigation to determine the single-use scope's ability to suction secretion from the lungs to resolve the collapse of the lung.

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.

Recruitment information / eligibility
Status Terminated
Enrollment 12
Est. completion date July 3, 2018
Est. primary completion date July 3, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Bronchoscopic procedure
Single-use flexible bronchoscope aScope 3 Large

Locations
Country Name City State
United States University of Chicago Medicine Chicago Illinois

Sponsors (1)
Lead Sponsor Collaborator
Ambu A/S

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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. 4 hours after procedure
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