Trial Outcomes & Findings for Evaluation of a Disposable Flexible Bronchoscope, aScope IV (NCT NCT02255838)
NCT ID: NCT02255838
Last Updated: 2022-04-26
Results Overview
Visualization of the two bronchoscopes was measured by using a qualitative scale from 0 to 10; 0 being classified as "cannot be evaluated" and 10 being assessed as optimal visualization
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
12 participants
Primary outcome timeframe
10 to 30 minutes
Results posted on
2022-04-26
Participant Flow
period August 8, 2015 to July 8, 2017 location: ICU
Participant milestones
| Measure |
Disposable Bronchoscope First (aScope IV), Then Reusable Bronchoscope (Storz 8402 2x)
Randomly controlled, either the disposable bronchoscope (aScope 4) was inserted first into the trachea and advanced into the right lung. Subsequently, a reusable bronchoscope (Storz 8402) was inserted into the trachea and advanced into the left lung. If randomization assigned the reusable bronchoscope to be inserted first, then the reusable bronchoscope was inserted into the trachea and advanced into the right lung first followed by insertion of the disposable bronchoscope and advancement into the left lung. The subsequent procedure was identical for both parts of this crossover trial and is described as follows: After insertion of the bronchoscope into the bronchial tree the scope was advanced to the basal segmental bronchi of the right or left lower lobe. The tip of the bronchoscope was brought into wedge position in one of the basal segments for broncho-alveolar lavage (BAL). A saline flush of 20 ml was administered. The flow of saline was observed at the distal tip of the bronchoscope. After 10 seconds of maintaining a wedge position, gentle suction was applied to collect the lavage specimen in the collection trap. This step was repeated 4 more times (total of 80 ml) to obtain an adequate specimen.
|
Reusable Bronchoscope First (Storz 8402 2x), Then Disposable Bronchoscope (aScope IV)
Randomly controlled, either the reusable bronchoscope (Storz 8402) was inserted first into the trachea and advanced into the right lung. Subsequently, disposable bronchoscope (aScope 4) was inserted into the trachea and advanced into the left lung. If randomization assigned the reusable bronchoscope to be inserted first, then the reusable bronchoscope was inserted into the trachea and advanced into the right lung first followed by insertion of the disposable bronchoscope and advancement into the left lung. The subsequent procedure was identical for both parts of this crossover trial and is described as follows: After insertion of the bronchoscope into the bronchial tree the scope was advanced to the basal segmental bronchi of the right or left lower lobe. The tip of the bronchoscope was brought into wedge position in one of the basal segments for broncho-alveolar lavage (BAL). A saline flush of 20 ml was administered. The flow of saline was observed at the distal tip of the bronchoscope. After 10 seconds of maintaining a wedge position, gentle suction was applied to collect the lavage specimen in the collection trap. This step was repeated 4 more times (total of 80 ml) to obtain an adequate specimen.
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|---|---|---|
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Overall Study
STARTED
|
6
|
6
|
|
Overall Study
COMPLETED
|
6
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evaluation of a Disposable Flexible Bronchoscope, aScope IV
Baseline characteristics by cohort
| Measure |
Disposable Bronchoscope Insertion Followed by Reusable Bronchoscope Insertion or Vice Versa
n=12 Participants
Randomly controlled, either the disposable bronchoscope (aScope 4) was inserted first into the trachea and advanced into the right lung. Subsequently, a reusable bronchoscope (Storz 8402) was inserted into the trachea and advanced into the left lung. If randomization assigned the reusable bronchoscope to be inserted first, then the reusable bronchoscope was inserted into the trachea and advanced into the right lung first followed by insertion of the disposable bronchoscope and advancement into the left lung. The subsequent procedure was identical for both parts of this crossover trial and is described as follows: After insertion of the bronchoscope into the bronchial tree the scope was advanced to the basal segmental bronchi of the right or left lower lobe. The tip of the bronchoscope was brought into wedge position in one of the basal segments for broncho-alveolar lavage (BAL). A saline flush of 20 ml was administered. The flow of saline was observed at the distal tip of the bronchoscope. After 10 seconds of maintaining a wedge position, gentle suction was applied to collect the lavage specimen in the collection trap. This step was repeated 4 more times (total of 80 ml) to obtain an adequate specimen.
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|---|---|
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Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
12 Participants
n=93 Participants
|
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Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
|
Age, Continuous
|
72 years
STANDARD_DEVIATION 10 • n=93 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=93 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=93 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
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Region of Enrollment
United States
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12 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: 10 to 30 minutesVisualization of the two bronchoscopes was measured by using a qualitative scale from 0 to 10; 0 being classified as "cannot be evaluated" and 10 being assessed as optimal visualization
Outcome measures
| Measure |
Bronchoscope Disposable, aScope IV
n=12 Participants
Randomly controlled, the disposable bronchoscope (aScope 4) was inserted into the trachea and advanced into the right lung or the disposable bronchoscope was inserted as the second bronchoscope into the left lung.
|
Reusable Bronchoscope (Storz 8402)
n=12 Participants
Randomly controlled, the reusable bronchoscope (Storz 8402) was inserted into the trachea and advanced into the right lung or the reusable bronchoscope was inserted as the second bronchoscope into the left lung.
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|---|---|---|
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Evaluation of Visualization of Two Different Flexible Bronchoscopes; a Disposable and a Reusable Bronchoscope
|
7.5 score on a scale
Standard Deviation 1.2
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8.0 score on a scale
Standard Deviation 0.7
|
PRIMARY outcome
Timeframe: 10-30 minutesHandling of the two bronchoscopes using a qualitative scale from 0 to 10; 0 being classified as "cannot be evaluated" and 10 being assessed as optimal visualization
Outcome measures
| Measure |
Bronchoscope Disposable, aScope IV
n=12 Participants
Randomly controlled, the disposable bronchoscope (aScope 4) was inserted into the trachea and advanced into the right lung or the disposable bronchoscope was inserted as the second bronchoscope into the left lung.
|
Reusable Bronchoscope (Storz 8402)
n=12 Participants
Randomly controlled, the reusable bronchoscope (Storz 8402) was inserted into the trachea and advanced into the right lung or the reusable bronchoscope was inserted as the second bronchoscope into the left lung.
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|---|---|---|
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Evaluation of the Handling of Two Different Flexible Bronchoscopes, a Disposable and a Reusable Bronchoscope
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8.0 score on a scale
Standard Deviation 1.5
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8.0 score on a scale
Standard Deviation 1.1
|
SECONDARY outcome
Timeframe: 10-30 minutesMeasured suction capability by volume retrieved after broncho-alveolar lavage with 10 ml of saline, measured in ml
Outcome measures
| Measure |
Bronchoscope Disposable, aScope IV
n=12 Participants
Randomly controlled, the disposable bronchoscope (aScope 4) was inserted into the trachea and advanced into the right lung or the disposable bronchoscope was inserted as the second bronchoscope into the left lung.
|
Reusable Bronchoscope (Storz 8402)
n=12 Participants
Randomly controlled, the reusable bronchoscope (Storz 8402) was inserted into the trachea and advanced into the right lung or the reusable bronchoscope was inserted as the second bronchoscope into the left lung.
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|---|---|---|
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Evaluation of Ability to Suction With Two Different Flexible Bronchoscopes, a Disposable and a Reusable Bronchoscope
|
5.4 milliliter
Standard Deviation 0.9
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5.3 milliliter
Standard Deviation 1.0
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SECONDARY outcome
Timeframe: 10-30 minutesFlexibility of the two bronchoscopes was measured by using a qualitative scale from 0 to 10; 0 being classified as "cannot be evaluated" and 10 being assessed as optimal flexibility
Outcome measures
| Measure |
Bronchoscope Disposable, aScope IV
n=12 Participants
Randomly controlled, the disposable bronchoscope (aScope 4) was inserted into the trachea and advanced into the right lung or the disposable bronchoscope was inserted as the second bronchoscope into the left lung.
|
Reusable Bronchoscope (Storz 8402)
n=12 Participants
Randomly controlled, the reusable bronchoscope (Storz 8402) was inserted into the trachea and advanced into the right lung or the reusable bronchoscope was inserted as the second bronchoscope into the left lung.
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|---|---|---|
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Evaluation of Flexibility of Two Different Flexible Bronchoscopes, a Disposable and a Reusable Bronchoscope
|
8.7 score on a scale
Standard Deviation 10
|
7.4 score on a scale
Standard Deviation 1.3
|
Adverse Events
Disposable Bronchoscope First (aScope IV), Then Reusable Bronchoscope (Storz 8402 2x)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Reusable Bronchoscope First (Storz 8402 2x), Then Disposable Bronchoscope (aScope IV)
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place