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Evaluation of a Disposable Flexible Bronchoscope, aScope IV
NA trial testing Bronchoscope reusable (Storz 8402 2x) in Respiratory Insufficiency in 12 participants. Terminated before completion.
| Lead sponsor | University of Louisville |
|---|---|
| Phase | NA |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | none |
| Primary purpose | diagnostic |
| Enrollment | 12 |
| Start date | 1 April 2015 |
| Primary completion | 14 January 2020 |
| Estimated completion | 14 January 2020 |
| Sites | 1 location across United States |
University of Louisville
Adults 18 to 80, any sex, with Respiratory Insufficiency or Pneumonia. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
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
| Group | Value | 95% CI |
|---|---|---|
| Bronchoscope Disposable, aScope IV | 7.5 | ± 1.2 |
| Reusable Bronchoscope (Storz 8402) | 8.0 | ± 0.7 |
Handling 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
| Group | Value | 95% CI |
|---|---|---|
| Bronchoscope Disposable, aScope IV | 8.0 | ± 1.5 |
| Reusable Bronchoscope(Storz 8402) | 8.0 | ± 1.1 |
Measured suction capability by volume retrieved after broncho-alveolar lavage with 10 ml of saline, measured in ml
| Group | Value | 95% CI |
|---|---|---|
| Bronchoscope Disposable, aScope IV | 5.4 | ± 0.9 |
| Bronchoscope Reusable Storz 8402 2x | 5.3 | ± 1.0 |
Flexibility 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
| Group | Value | 95% CI |
|---|---|---|
| Bronchoscope Disposable, aScope IV | 8.7 | ± 10 |
| Bronchoscope Reusable Storz 8402 2x | 7.4 | ± 1.3 |
Flexible bronchoscopes are typically reusable and therefore need high level disinfection to prevent inadvertent spread of microbial pathogens from patient to patient. The process of disinfection is time consuming and expensive. Moreover, a bronchoscope being processed may not be readily available for another patient. One solution to this problem was to use a single use disposable sheath that covers a flexible bronchoscope protecting all surfaces of the bronchoscope.(Colt, Beamis, Harrell, \& Mathur, 2000). Another way to eliminate potential hazards with a reusable bronchoscope is the use of a disposable bronchoscope. Such a disposable bronchoscope has been developed (Ambu aScope, Ambu, Glen Burnie, MD) and has been used successfully for intubations in manikins(Scutt et al., 2011) and patients. (Kristensen \& Fredensborg, 2013; Pujol, López, \& Valero, 2010; Tvede, Kristensen, \& Nyhus-Andreasen, 2012). Further advancement in the imaging and handling of this disposable flexible bronchoscope now allows for the purpose of bronchoscopy and broncho-alveolar lavage in critically ill patients with pulmonary compromise. (FDA approval: 05-11-2013 date) The aim of the study is to compare image clarity, suction capacity, and handling performance of a reusable flexible bronchoscope to the disposable flexible bronchoscope. In addition, the investigators intend to perform a cost analysis.
No peer-reviewed publications indexed yet for this trial.
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