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

Ambu A/S1 site in 1 country12 target enrollmentSeptember 28, 2017

ConditionsAtelectasis Bronchoscopy

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Atelectasis
Sponsor: Ambu A/S
Enrollment: 12
Locations: 1
Primary Endpoint: Improvement in Oxygenation (PaO2/FiO2 Ratio) After a BAL Treatment
Status: Terminated
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

September 28, 2017

End Date

July 3, 2018

Last Updated

6 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Ambu A/S

Responsible Party

Sponsor

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

Outcomes

Primary Outcomes

Improvement in Oxygenation (PaO2/FiO2 Ratio) After a BAL Treatment

Time Frame: 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.