Atelectasis, Bronchoscopy
Conditions
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.
Interventions
DEVICEBronchoscopic procedure
Single-use flexible bronchoscope aScope 3 Large
Sponsors
Ambu A/S
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| aScope 3 Large Bronchoscopic procedure
Bronchoscopic procedure: Single-use flexible bronchoscope aScope 3 Large | 12 |
| Total | 12 |
Baseline characteristics
| Characteristic | aScope 3 Large | — |
|---|---|---|
| Age, Continuous | 54.2 years STANDARD_DEVIATION 16.7 | — |
| ASA-score I. | 0 Participants | — |
| ASA-score II. | 5 Participants | — |
| ASA-score III. | 6 Participants | — |
| ASA-score IV. | 1 Participants | — |
| ASA-score V. | 0 Participants | — |
| Endotracheal tube size Size 7 | 1 Participants | — |
| Endotracheal tube size Size 7.5 | 4 Participants | — |
| Endotracheal tube size Size 8 | 6 Participants | — |
| Endotracheal tube size Size 8.5 | 1 Participants | — |
| Height | 173.9 cm STANDARD_DEVIATION 10.2 | — |
| Indication for invasive mechanical ventilation aortic regurgitation | 1 Participants | — |
| Indication for invasive mechanical ventilation Cardiac arrest | 1 Participants | — |
| Indication for invasive mechanical ventilation Cardiogenic shock | 4 Participants | — |
| Indication for invasive mechanical ventilation Lung transplant | 1 Participants | — |
| Indication for invasive mechanical ventilation Respiratory failure | 4 Participants | — |
| Indication for invasive mechanical ventilation Severe aortic stenosis | 1 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 3 Participants | — |
| Sex: Female, Male Male | 9 Participants | — |
| Weight | 113.3 kg STANDARD_DEVIATION 39.3 | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 12 |
| other Total, other adverse events | 0 / 12 |
| serious Total, serious adverse events | 0 / 12 |
Outcome results
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.
Time frame: 4 hours after procedure
Population: Missing data at 4h post measures for one subject
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| aScope 3 Large | Improvement in Oxygenation (PaO2/FiO2 Ratio) After a BAL Treatment | PaO2/FiO2 Baseline | 194.69 PaO2/FiO2 | Standard Deviation 111.27 |
| aScope 3 Large | Improvement in Oxygenation (PaO2/FiO2 Ratio) After a BAL Treatment | PaO2/FiO2 4h post | 211.54 PaO2/FiO2 | Standard Deviation 94.92 |