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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-28

Study Completion Date

2018-07-03

Brief Summary

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

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Detailed Description

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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.

Conditions

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Atelectasis Bronchoscopy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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aScope 3 Large

Bronchoscopic procedure

Group Type OTHER

Bronchoscopic procedure

Intervention Type DEVICE

Single-use flexible bronchoscope aScope 3 Large

Interventions

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Bronchoscopic procedure

Single-use flexible bronchoscope aScope 3 Large

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No