Trial Outcomes & Findings for Evaluation of BAL Procedure With Ambu aScope 3 Large in Patients in an ICU Setting (NCT NCT03581474)

NCT ID: NCT03581474

Last Updated: 2020-02-13

Results Overview

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.

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 12 participants
• Primary outcome timeframe: 4 hours after procedure
• Results posted on: 2020-02-13

Participant Flow

Participant milestones

Measure	aScope 3 Large Bronchoscopic procedure Bronchoscopic procedure: Single-use flexible bronchoscope aScope 3 Large
Overall Study STARTED	12
Overall Study COMPLETED	12
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	aScope 3 Large n=12 Participants Bronchoscopic procedure Bronchoscopic procedure: Single-use flexible bronchoscope aScope 3 Large
Age, Continuous	54.2 years STANDARD_DEVIATION 16.7 • n=12 Participants
Sex: Female, Male Female	3 Participants n=12 Participants
Sex: Female, Male Male	9 Participants n=12 Participants
Height	173.9 cm STANDARD_DEVIATION 10.2 • n=12 Participants
Weight	113.3 kg STANDARD_DEVIATION 39.3 • n=12 Participants
ASA-score I.	0 Participants n=12 Participants
ASA-score II.	5 Participants n=12 Participants
ASA-score III.	6 Participants n=12 Participants
ASA-score IV.	1 Participants n=12 Participants
ASA-score V.	0 Participants n=12 Participants
Indication for invasive mechanical ventilation Cardiogenic shock	4 Participants n=12 Participants
Indication for invasive mechanical ventilation Lung transplant	1 Participants n=12 Participants
Indication for invasive mechanical ventilation Respiratory failure	4 Participants n=12 Participants
Indication for invasive mechanical ventilation Cardiac arrest	1 Participants n=12 Participants
Indication for invasive mechanical ventilation Severe aortic stenosis	1 Participants n=12 Participants
Indication for invasive mechanical ventilation aortic regurgitation	1 Participants n=12 Participants
Endotracheal tube size Size 7	1 Participants n=12 Participants
Endotracheal tube size Size 7.5	4 Participants n=12 Participants
Endotracheal tube size Size 8	6 Participants n=12 Participants
Endotracheal tube size Size 8.5	1 Participants n=12 Participants

PRIMARY outcome

Timeframe: 4 hours after procedure

Population: Missing data at 4h post measures for one subject

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.

Outcome measures

Measure	aScope 3 Large n=12 Participants Bronchoscopic procedure Bronchoscopic procedure: Single-use flexible bronchoscope aScope 3 Large
Improvement in Oxygenation (PaO2/FiO2 Ratio) After a BAL Treatment PaO2/FiO2 Baseline	194.69 PaO2/FiO2 Standard Deviation 111.27
Improvement in Oxygenation (PaO2/FiO2 Ratio) After a BAL Treatment PaO2/FiO2 4h post	211.54 PaO2/FiO2 Standard Deviation 94.92

Adverse Events

aScope 3 Large

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Anna Charlotte Lundgaard

Ambu A/S

Phone: +4529643748

Email: aclu@ambu.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place