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

Evaluation of a Bronchoalveolar Lavage Procedure With a Flexible Disposable Bronchoscope, Ambu aScope 3 Large in Patients in an Intensive Care Unit Setting

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

Study Overview

• Status: Terminated
• Conditions: Bronchoscopy; Atelectasis
• Intervention / Treatment: Device: Bronchoscopic procedure

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 Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60637
      • University of Chicago Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: aScope 3 Large; Bronchoscopic procedure	Device: Bronchoscopic procedure; Single-use flexible bronchoscope aScope 3 Large

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Ambu A/S
• Investigators: Study Chair: Anna Charlotte Lundgaard, Ambu A/S

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 28, 2017
• Primary Completion (ACTUAL): July 3, 2018
• Study Completion (ACTUAL): July 3, 2018

Study Registration Dates

• First Submitted: September 22, 2017
• First Submitted That Met QC Criteria: July 9, 2018
• First Posted (ACTUAL): July 10, 2018

Study Record Updates

• Last Update Posted (ACTUAL): February 13, 2020
• Last Update Submitted That Met QC Criteria: February 3, 2020
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Pulmonary Atelectasis
• Other Study ID Numbers: CIS-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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