Respiratory InsufficiencyEVALNCT02255838
Evaluation of a Disposable Flexible Bronchoscope, aScope IV
A study testing Bronchoscope reusable (Storz 8402 2x) and Bronchoscope disposable (aScope 4) in people with Respiratory Insufficiency and Pneumonia, run by University of Louisville at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Respiratory Insufficiency, Pneumonia, Atelectasis
- What is being tested?
- Bronchoscope reusable (Storz 8402 2x) and Bronchoscope disposable (aScope 4)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2015to 14 Jan 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult 18 years old and older
- Capable of giving informed consent or have an acceptable surrogate capable of giving legally authorized consent on the subject's behalf.
- Indication of a diagnostic and or therapeutic bronchoscopy as determined by the attending critical care physician
- Being cared for in the critical care units at the U of L Hospital
Who cannot join
- 1) Patient is moribund and a bronchoscopy is very unlikely to reduce impending mortality or can avert death
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Louisville School of Medicine
Louisville, Kentucky, 40202
About this study
Official title: Evaluation of a Disposable Flexible Bronchoscope, (aScope IV) a Randomized, Controlled, Cross-over Trial
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.
Read the detailed description
Description
Patients will be monitored by standard NIBP or invasive arterial lines, ECG and oxygen saturation. All patients are intubated due to their respiratory insufficiency or for airway protection. Patients will be anesthetized for the procedure. Anesthesia will be induced with versed 2mg, fentanyl 100 µg and paralyzed with 0.1mg/kg vecuronium. Anesthesia will be maintained with propofol infusion 50-150 µg/kg/min.
Study Procedures All patients will be under general anesthesia. Standard monitoring will be applied. This includes a blood pressure cuff or an arterial line, EKG and a pulse-oximeter. Patients will receive 2 mg/kg propofol, 1µg/kg fentanyl and 0.1mg/kg vecuronium for the procedure. After induction of anesthesia the FiO2 will be turned to 1.0 and a bronchoscopy adaptor will be interposed in the breathing circuit next to the endotracheal tube. Patients will be randomized to receiving either the non-disposable bronchoscope (Storz 8402 2x, El Segundo, CA) or the single use aScope 3 first. After randomization, bronchoscopy will be started with an inspection of the trachea and carina. Next the right lung bronchial tree will be inspected systematically beginning with the right upper lobe, following with the right middle lobe and finishing with the right lower lobe. All segmental bronchi will be inspected and cleaned by suction as deemed necessary. The bronchoscope will then be removed from the bronchial tree and rinsed with saline Subsequently, the bronchoscope will be re-inserted and advanced to the basal segmental bronchi of the right lower lobe. The tip of the bronchoscope will be brought into wedge position in one of the basal segments for broncho-alveolar lavage (BAL). A saline flush of 20 ml will be administered. The flow of saline will be observed at the distal tip of the bronchoscope. After 10 seconds of maintaining a wedge position, gentle suction will be applied to collect the lavage specimen in the collection trap. This step will be repeated 4 more times (total of 80ml) to obtain an adequate specimen. The same procedure will be repeated on the left lung using the alternate bronchoscope according to randomization. At the end of the procedure, a chest radiograph will be obtained to rule out pneumothorax.
Measurements
Before starting the procedure the set up time of each bronchoscope will be recorded. The view, image, and light of each bronchoscope will be assessed, then the inspection of the upper lobe segmental bronchi will be conducted. The time of lavage and suctioning until no more specimen can be collected will be measured. The volume of the obtained specimen will be measured. The specimen will be evaluated by a blinded observer after the procedure is completed.(clear fluids, mucous secretions, viscous secretions, pus, blood etc). The blinded observer will evaluate the quality and quanity of the sample for obtaining cultures.The blinded observer will be an attending or resident from the infectious disease department.
The overall ease of handling will be rated directly after the procedure by the investigator. All bronchoscopies will be taped and view-clarity, image and light-brightness will be assessed by a second blinded observer. This blinder observer can be another investigator not present during the procedure or an internist who was not present and is part of the study team.
All assessments will be performed using a VAS scale of 0 to 10 cm as shown below. The investigator will mark directly on the scale.
We will only enroll patients who were admitted to a critical care unit at the University of Louisville and who are intubated.
- Conditions
- Respiratory Insufficiency, Pneumonia, Atelectasis
- Being tested
- Bronchoscope reusable (Storz 8402 2x), Bronchoscope disposable (aScope 4)
- Medical subject headings
- Respiratory Insufficiency, Pneumonia, Pulmonary Atelectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bronchoscope reusable (Storz 8402 2x)Device
Also called Storz 8402 2x (Storz, El Segundo, CA)
Bronchoscopy and alveolar lavage
Bronchoscope disposable (aScope 4)Device
Also called aScope 4 (Ambu, Glen Burnie, MD)
Bronchoscopy and alveolar lavage
| Study group | Role | What they receive |
|---|---|---|
| Disposable bronchoscope first (aScope IV), then Reusable bronchoscope (Storz 8402 2x) | Experimental | the bronchoscope will be re-inserted and advanced to the basal segmental bronchi of the right lower lobe. The tip of the bronchoscope will be brought into wedge position in one of the basal segments for broncho-alveolar lavage (BAL). A saline flush of 20 ml will be administered. The flow of saline will be observed at the distal tip of the bronchoscope. After 10 seconds of maintaining a wedge position, gentle suction will be applied to collect the lavage specimen in the collection trap. This step will be repeated 4 more times (total of 80ml) to obtain an adequate specimen. Receives: Device: Bronchoscope disposable (aScope 4) |
| Reusable bronchoscope first (Storz 8402 2x), then Disposable bronchoscope (aScope IV) | Active comparator | the bronchoscope will be re-inserted and advanced to the basal segmental bronchi of the right lower lobe. The tip of the bronchoscope will be brought into wedge position in one of the basal segments for broncho-alveolar lavage (BAL). A saline flush of 20 ml will be administered. The flow of saline will be observed at the distal tip of the bronchoscope. After 10 seconds of maintaining a wedge position, gentle suction will be applied to collect the lavage specimen in the collection trap. This step will be repeated 4 more times (total of 80ml) to obtain an adequate specimen. Receives: Device: Bronchoscope reusable (Storz 8402 2x) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of Visualization of Two Different Flexible Bronchoscopes; a Disposable and a Reusable Bronchoscope
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
Measured: 10 to 30 minutes
Evaluation of the Handling of Two Different Flexible Bronchoscopes, a Disposable and a Reusable Bronchoscope
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
Measured: 10-30 minutes
Secondary outcomes (2)
Evaluation of Ability to Suction With Two Different Flexible Bronchoscopes, a Disposable and a Reusable Bronchoscope
Measured suction capability by volume retrieved after broncho-alveolar lavage with 10 ml of saline, measured in ml
Measured: 10-30 minutes
Evaluation of Flexibility of Two Different Flexible Bronchoscopes, a Disposable and a Reusable Bronchoscope
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
Measured: 10-30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2014 (estimated)
- Study start1 Apr 2015
- Primary completion14 Jan 2020
- Study completion14 Jan 2020
Why it stopped: slow enrollment, outdated material
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for Respiratory InsufficiencyStudies of the same condition, open and under way.
- More trials run by University of LouisvilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- The disposable aScope IV bronchoscope will be compared to the re-usable bronchoscope
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Louisville
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rainer Lenhardt, University of Louisville
- Investigators
- Rainer Lenhardt, MD MBA, Principal investigator, University of Louisville School of Medicine Department of Anesthesiology and Perioperative Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02255838
- Sponsor's protocol ID
- 14.0689
- Acronym
- EVAL
- Status last verified
- Apr 2022
- First submitted
- 24 Sep 2014
- Last updated
- 26 Apr 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Bellomo R, Tai E, Parkin G. Fibreoptic bronchoscopy in the critically ill: a prospective study of its diagnostic and therapeutic value. Anaesth Intensive Care. 1992 Nov;20(4):464-9. doi: 10.1177/0310057X9202000412.
PubMed 1463174Colt HG, Beamis JJ, Harrell JH, Mathur PM. Novel flexible bronchoscope and single-use disposable-sheath endoscope system. A preliminary technology evaluation. Chest. 2000 Jul;118(1):183-7. doi: 10.1378/chest.118.1.183.
PubMed 10893377Estella A. [Analysis of 208 flexible bronchoscopies performed in an intensive care unit]. Med Intensiva. 2012 Aug-Sep;36(6):396-401. doi: 10.1016/j.medin.2011.11.005. Epub 2011 Dec 20. Spanish.
PubMed 22192316Facciolongo N, Patelli M, Gasparini S, Lazzari Agli L, Salio M, Simonassi C, Del Prato B, Zanoni P. Incidence of complications in bronchoscopy. Multicentre prospective study of 20,986 bronchoscopies. Monaldi Arch Chest Dis. 2009 Mar;71(1):8-14. doi: 10.4081/monaldi.2009.370.
PubMed 19522159Georgiades G, Myrianthefs P, Venetsanou K, Kythreoti A, Kyroudi A, Kittas C, Baltopoulos G. Temperature and serum proinflammatory cytokine changes in patients with NSCLC after BAL. Lung. 2003;181(1):35-47. doi: 10.1007/s00408-003-1001-6.
PubMed 12879338Huang YC, Bassett MA, Levin D, Montilla T, Ghio AJ. Acute phase reaction in healthy volunteers after bronchoscopy with lavage. Chest. 2006 Jun;129(6):1565-9. doi: 10.1378/chest.129.6.1565.
PubMed 16778276Ikeda S, Yanai N, Ishikawa S. Flexible bronchofiberscope. Keio J Med. 1968 Mar;17(1):1-16. doi: 10.2302/kjm.17.1. No abstract available.
PubMed 5674435Kreider ME, Lipson DA. Bronchoscopy for atelectasis in the ICU: a case report and review of the literature. Chest. 2003 Jul;124(1):344-50. doi: 10.1378/chest.124.1.344.
PubMed 12853543Kristensen MS, Fredensborg BB. The disposable Ambu aScope vs. a conventional flexible videoscope for awake intubation -- a randomised study. Acta Anaesthesiol Scand. 2013 Aug;57(7):888-95. doi: 10.1111/aas.12094. Epub 2013 Mar 15.
PubMed 23495767Lucena CM, Martinez-Olondris P, Badia JR, Xaubet A, Ferrer M, Torres A, Agusti C. [Fiberoptic bronchoscopy in a respiratory intensive care unit]. Med Intensiva. 2012 Aug-Sep;36(6):389-95. doi: 10.1016/j.medin.2011.11.004. Epub 2011 Dec 22. Spanish.
PubMed 22195599Perkins GD, Chatterjie S, McAuley DF, Gao F, Thickett DR. Role of nonbronchoscopic lavage for investigating alveolar inflammation and permeability in acute respiratory distress syndrome. Crit Care Med. 2006 Jan;34(1):57-64. doi: 10.1097/01.ccm.0000190197.69945.c5.
PubMed 16374157Pujol E, Lopez AM, Valero R. Use of the Ambu((R)) aScope in 10 patients with predicted difficult intubation. Anaesthesia. 2010 Oct;65(10):1037-40. doi: 10.1111/j.1365-2044.2010.06477.x.
PubMed 20707786Du Rand IA, Blaikley J, Booton R, Chaudhuri N, Gupta V, Khalid S, Mandal S, Martin J, Mills J, Navani N, Rahman NM, Wrightson JM, Munavvar M; British Thoracic Society Bronchoscopy Guideline Group. Summary of the British Thoracic Society guideline for diagnostic flexible bronchoscopy in adults. Thorax. 2013 Aug;68(8):786-7. doi: 10.1136/thoraxjnl-2013-203629.
PubMed 23842821Scutt S, Clark N, Cook TM, Smith C, Christmas T, Coppel L, Crewdson K. Evaluation of a single-use intubating videoscope (Ambu aScope ) in three airway training manikins for oral intubation, nasal intubation and intubation via three supraglottic airway devices. Anaesthesia. 2011 Apr;66(4):293-9. doi: 10.1111/j.1365-2044.2011.06647.x. Epub 2011 Feb 24.
PubMed 21401543Sharif-Kashani B, Shahabi P, Behzadnia N, Mohammad-Taheri Z, Mansouri D, Masjedi MR, Zargari L, Salimi Negad L. Incidence of fever and bacteriemia following flexible fiberoptic bronchoscopy: a prospective study. Acta Med Iran. 2010 Nov-Dec;48(6):385-8.
PubMed 21287478
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Disposable Flexible Bronchoscope, (aScope IV) a Randomized, Controlled, Cross-over Trial
- ClinicalTrials.gov ID
- NCT02255838
- Acronym / sponsor ID
- EVAL / 14.0689
- Conditions
- Respiratory Insufficiency, Pneumonia, Atelectasis
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: slow enrollment, outdated material
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of LouisvilleUniversity, hospital or other
- Study start
- 1 Apr 2015 (actual)
- Primary completion
- 14 Jan 2020 (actual)
- Study completion
- 14 Jan 2020 (actual)
- First posted
- 3 Oct 2014 (estimated)
- Results
- Posted 26 Apr 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Description
Patients will be monitored by standard NIBP or invasive arterial lines, ECG and oxygen saturation. All patients are intubated due to their respiratory insufficiency or for airway protection. Patients will be anesthetized for the procedure. Anesthesia will be induced with versed 2mg, fentanyl 100 µg and paralyzed with 0.1mg/kg vecuronium. Anesthesia will be maintained with propofol infusion 50-150 µg/kg/min.
Study Procedures All patients will be under general anesthesia. Standard monitoring will be applied. This includes a blood pressure cuff or an arterial line, EKG and a pulse-oximeter. Patients will receive 2 mg/kg propofol, 1µg/kg fentanyl and 0.1mg/kg vecuronium for the procedure. After induction of anesthesia the FiO2 will be turned to 1.0 and a bronchoscopy adaptor will be interposed in the breathing circuit next to the endotracheal tube. Patients will be randomized to receiving either the non-disposable bronchoscope (Storz 8402 2x, El Segundo, CA) or the single use aScope 3 first. After randomization, bronchoscopy will be started with an inspection of the trachea and carina. Next the right lung bronchial tree will be inspected systematically beginning with the right upper lobe, following with the right middle lobe and finishing with the right lower lobe. All segmental bronchi will be inspected and cleaned by suction as deemed necessary. The bronchoscope will then be removed from the bronchial tree and rinsed with saline Subsequently, the bronchoscope will be re-inserted and advanced to the basal segmental bronchi of the right lower lobe. The tip of the bronchoscope will be brought into wedge position in one of the basal segments for broncho-alveolar lavage (BAL). A saline flush of 20 ml will be administered. The flow of saline will be observed at the distal tip of the bronchoscope. After 10 seconds of maintaining a wedge position, gentle suction will be applied to collect the lavage specimen in the collection trap. This step will be repeated 4 more times (total of 80ml) to obtain an adequate specimen. The same procedure will be repeated on the left lung using the alternate bronchoscope according to randomization. At the end of the procedure, a chest radiograph will be obtained to rule out pneumothorax.
Measurements
Before starting the procedure the set up time of each bronchoscope will be recorded. The view, image, and light of each bronchoscope will be assessed, then the inspection of the upper lobe segmental bronchi will be conducted. The time of lavage and suctioning until no more specimen can be collected will be measured. The volume of the obtained specimen will be measured. The specimen will be evaluated by a blinded observer after the procedure is completed.(clear fluids, mucous secretions, viscous secretions, pus, blood etc). The blinded observer will evaluate the quality and quanity of the sample for obtaining cultures.The blinded observer will be an attending or resident from the infectious disease department.
The overall ease of handling will be rated directly after the procedure by the investigator. All bronchoscopies will be taped and view-clarity, image and light-brightness will be assessed by a second blinded observer. This blinder observer can be another investigator not present during the procedure or an internist who was not present and is part of the study team.
All assessments will be performed using a VAS scale of 0 to 10 cm as shown below. The investigator will mark directly on the scale.
We will only enroll patients who were admitted to a critical care unit at the University of Louisville and who are intubated.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The disposable aScope IV bronchoscope will be compared to the re-usable bronchoscope
| Arm | Type | Receives |
|---|---|---|
| Disposable bronchoscope first (aScope IV), then Reusable bronchoscope (Storz 8402 2x) | Experimental | Device: Bronchoscope disposable (aScope 4)the bronchoscope will be re-inserted and advanced to the basal segmental bronchi of the right lower lobe. The tip of the bronchoscope will be brought into wedge position in one of the basal segments for broncho-alveolar lavage (BAL). A saline flush of 20 ml will be administered. The flow of saline will be observed at the distal tip of the bronchoscope. After 10 seconds of maintaining a wedge position, gentle suction will be applied to collect the lavage specimen in the collection trap. This step will be repeated 4 more times (total of 80ml) to obtain an adequate specimen. |
| Reusable bronchoscope first (Storz 8402 2x), then Disposable bronchoscope (aScope IV) | Active comparator | Device: Bronchoscope reusable (Storz 8402 2x)the bronchoscope will be re-inserted and advanced to the basal segmental bronchi of the right lower lobe. The tip of the bronchoscope will be brought into wedge position in one of the basal segments for broncho-alveolar lavage (BAL). A saline flush of 20 ml will be administered. The flow of saline will be observed at the distal tip of the bronchoscope. After 10 seconds of maintaining a wedge position, gentle suction will be applied to collect the lavage specimen in the collection trap. This step will be repeated 4 more times (total of 80ml) to obtain an adequate specimen. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult 18 years old and older
- Capable of giving informed consent or have an acceptable surrogate capable of giving legally authorized consent on the subject's behalf.
- Indication of a diagnostic and or therapeutic bronchoscopy as determined by the attending critical care physician
- Being cared for in the critical care units at the U of L Hospital
Key exclusion criteria (1 listed)
- 1) Patient is moribund and a bronchoscopy is very unlikely to reduce impending mortality or can avert death
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bronchoscope reusable (Storz 8402 2x)Also: Storz 8402 2x (Storz, El Segundo, CA)Bronchoscopy and alveolar lavage | Device | Reusable bronchoscope first (Storz 8402 2x), then Disposable bronchoscope (aScope IV) |
| Bronchoscope disposable (aScope 4)Also: aScope 4 (Ambu, Glen Burnie, MD)Bronchoscopy and alveolar lavage | Device | Disposable bronchoscope first (aScope IV), then Reusable bronchoscope (Storz 8402 2x) |
Primary outcome
Evaluation of Visualization of Two Different Flexible Bronchoscopes; a Disposable and a Reusable Bronchoscope
Time frame: 10 to 30 minutes
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
Evaluation of the Handling of Two Different Flexible Bronchoscopes, a Disposable and a Reusable Bronchoscope
Time frame: 10-30 minutes
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
2 secondary outcomes
Evaluation of Ability to Suction With Two Different Flexible Bronchoscopes, a Disposable and a Reusable Bronchoscope
Time frame: 10-30 minutes
Evaluation of Flexibility of Two Different Flexible Bronchoscopes, a Disposable and a Reusable Bronchoscope
Time frame: 10-30 minutes
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 1463174Bellomo R, Tai E, Parkin G. Fibreoptic bronchoscopy in the critically ill: a prospective study of its diagnostic and therapeutic value. Anaesth Intensive Care. 1992 Nov;20(4):464-9. doi: 10.1177/0310057X9202000412.
- Background: PubMed 10893377Colt HG, Beamis JJ, Harrell JH, Mathur PM. Novel flexible bronchoscope and single-use disposable-sheath endoscope system. A preliminary technology evaluation. Chest. 2000 Jul;118(1):183-7. doi: 10.1378/chest.118.1.183.
- Background: PubMed 22192316Estella A. [Analysis of 208 flexible bronchoscopies performed in an intensive care unit]. Med Intensiva. 2012 Aug-Sep;36(6):396-401. doi: 10.1016/j.medin.2011.11.005. Epub 2011 Dec 20. Spanish.
- Background: PubMed 19522159Facciolongo N, Patelli M, Gasparini S, Lazzari Agli L, Salio M, Simonassi C, Del Prato B, Zanoni P. Incidence of complications in bronchoscopy. Multicentre prospective study of 20,986 bronchoscopies. Monaldi Arch Chest Dis. 2009 Mar;71(1):8-14. doi: 10.4081/monaldi.2009.370.
- Background: PubMed 12879338Georgiades G, Myrianthefs P, Venetsanou K, Kythreoti A, Kyroudi A, Kittas C, Baltopoulos G. Temperature and serum proinflammatory cytokine changes in patients with NSCLC after BAL. Lung. 2003;181(1):35-47. doi: 10.1007/s00408-003-1001-6.
- Background: PubMed 16778276Huang YC, Bassett MA, Levin D, Montilla T, Ghio AJ. Acute phase reaction in healthy volunteers after bronchoscopy with lavage. Chest. 2006 Jun;129(6):1565-9. doi: 10.1378/chest.129.6.1565.
- Background: PubMed 5674435Ikeda S, Yanai N, Ishikawa S. Flexible bronchofiberscope. Keio J Med. 1968 Mar;17(1):1-16. doi: 10.2302/kjm.17.1. No abstract available.
- Background: PubMed 12853543Kreider ME, Lipson DA. Bronchoscopy for atelectasis in the ICU: a case report and review of the literature. Chest. 2003 Jul;124(1):344-50. doi: 10.1378/chest.124.1.344.
- Background: PubMed 23495767Kristensen MS, Fredensborg BB. The disposable Ambu aScope vs. a conventional flexible videoscope for awake intubation -- a randomised study. Acta Anaesthesiol Scand. 2013 Aug;57(7):888-95. doi: 10.1111/aas.12094. Epub 2013 Mar 15.
- Background: PubMed 22195599Lucena CM, Martinez-Olondris P, Badia JR, Xaubet A, Ferrer M, Torres A, Agusti C. [Fiberoptic bronchoscopy in a respiratory intensive care unit]. Med Intensiva. 2012 Aug-Sep;36(6):389-95. doi: 10.1016/j.medin.2011.11.004. Epub 2011 Dec 22. Spanish.
- Background: PubMed 16374157Perkins GD, Chatterjie S, McAuley DF, Gao F, Thickett DR. Role of nonbronchoscopic lavage for investigating alveolar inflammation and permeability in acute respiratory distress syndrome. Crit Care Med. 2006 Jan;34(1):57-64. doi: 10.1097/01.ccm.0000190197.69945.c5.
- Background: PubMed 20707786Pujol E, Lopez AM, Valero R. Use of the Ambu((R)) aScope in 10 patients with predicted difficult intubation. Anaesthesia. 2010 Oct;65(10):1037-40. doi: 10.1111/j.1365-2044.2010.06477.x.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rainer Lenhardt, MD MBA principal investigator
University of Louisville School of Medicine Department of Anesthesiology and Perioperative Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bronchoscope reusable (Storz 8402 2x) and Bronchoscope disposable (aScope 4) in people with Respiratory Insufficiency and Pneumonia, run by University of Louisville at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 26 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Apr 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of Visualization of Two Different Flexible Bronchoscopes; a Disposable and a Reusable Bronchoscope (time frame: 10 to 30 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02255838, which also lists 19 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2022.