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

Not Applicable

Terminated

• Conditions: Bronchoscopy; Atelectasis
• Interventions: Device: Bronchoscopic procedure

• Registration Number: NCT03581474
• Lead Sponsor: Ambu A/S

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.

Study Timeline

• Study First Submitted: 2017-09-22
• Study Start: 2017-09-28
• Status Verified: 2018-06
• Primary Completion: 2018-07-03
• Study Completion: 2018-07-03
• Study First Submitted QC: 2018-07-09
• Study First Posted: 2018-07-10
• Results First Submitted: 2019-10-14
• Results First Submitted QC: 2020-02-03
• Last Update Submitted: 2020-02-03
• Results First Posted: 2020-02-13
• Last Update Posted: 2020-02-13

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 12

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
aScope 3 Large	Bronchoscopic procedure	Bronchoscopic procedure

Primary Outcome Measures

Name	Time	Method
Improvement in Oxygenation (PaO2/FiO2 Ratio) After a BAL Treatment	4 hours after procedure	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.

Trial Locations

Locations (1)

University of Chicago Medicine; 🇺🇸 Chicago, Illinois, United States