Respiratory InsufficiencyTraSUBNCT03952247
"TRAcheostomy With Single Use Bronchoscopes vs. Conventional Bronchoscopes"
A study testing Single Use Bronchoscopy for PDT and Conventional Multi Use Bronchoscopy for PDT in people with Respiratory Insufficiency, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
Trial summary
Optical guidance for percutaneous tracheostomy in intensive care is usually performed by conventional multi use bronchoscopy. Recently a single use bronchoscope has been introduced that allows for endotracheal visualization. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiratory Insufficiency
- What is being tested?
- Single Use Bronchoscopy for PDT and Conventional Multi Use Bronchoscopy for PDT
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteGermany
- Study dates
- 15 May 2019to 4 Nov 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients receiving percutaneous tracheotomy in the Dept. of Intensive Care Medicine.
- Age ≥ 18 years
- Informed consent
Who cannot join
- Age < 18 years
- No consent
- Direct laryngoscopy according to Cormack-Lehane ≥ 3
Trial locations and contacts
1 site in 1 country.
Germany1 site
Universitätsklinikum Hamburg-Eppendorf
Hamburg, Free and Hanseatic City of Hamburg, 20246
About this study
Official title: Prospective, Randomized Study in Ventilated Critically Ill Patients Receiving Percutaneous Tracheotomy. A Comparison of Periinterventional Visualization of Conventional Bronchoscopy and Single Use Bronchoscopy (TraSUB™)
Optical guidance for percutaneous tracheostomy in intensive care is usually performed by conventional multi use bronchoscopy. Recently a single use bronchoscope has been introduced that allows for endotracheal visualization.
For feasibility evaluation, 23 patients in intensive care receive percutaneous tracheostomy with optical guidance by the Ambu® aScopeTM 4 bronchoscope and 23 patients in intensive care receive percutaneous tracheostomy with a conventional bronchoscope (Olympus BF Type P60). The primary end point is the visualization through the single use bronchoscope of endotracheal landmark structures for tracheostomy and visualization of the needle insertion (according to score, see detailed description).
Read the detailed description
Background Long-term ventilated critically ill patients often receive a tracheostomy to facilitate weaning from the ventilator and for prevention of secondary complications by the endotracheal tube. Besides surgical tracheostomy in which a muco-cutaneous fistula is prepared between trachea and outer skin, percutaneous tracheostomy (PDT) has been introduced, in which a cannula is being inserted into the trachea. After introduction of a guidewire, the trachea is then dilated. This intervention should be led by optical guidance, i. e. to verify the correct point of tracheal cannulation between the 2nd and 3rd tracheal cartilage and to minimize the risk for accidental injury to the membranous part of the trachea. Usually, optical guidance is performed by conventional multi use bronchoscopy. During bronchoscopy in ventilated patients, a drop in minute ventilation or an increase of carbon dioxide partial pressure with a consecutive respiratory acidosis may occur. Recently, a single use bronchoscope has been introduced that permits a continuous visualisation of the trachea on a monitor connected to the camera (Ambu® aScopeTM 4, Ambu, Ballerup, Denmark) . In this study, it is being evaluated whether the optical guidance during PDT can be performed by the Ambu® aScope 4. The advantage of a single use bronchoscope for percutaneous dilatative tracheostomy in comparison to a conventional reuseable bronchoscope is that there is no need for repair or decontamination after use.
Methods:
Design of Study/ No. of Patients:
Randomized, prospective study/ 46 patients With a sample size of 46 (randomized 1:1 in 2 groups of 23 each) a difference of 35% on a visualization score [6] may be seen with an α-error of 0,05 and a β-error of 1-0,8.
Procedures:
- screening for study inclusion according to inclusion and exclusion criteria.
- Percutaneous tracheostomy with Ciaglia Blue Rhino technique
- Visualization of PDT via a conventional multi use bronchoscope vs the aScopeTM 4 single use bronchoscope. study inclusion: All patients being treated in the Dept. of Intensive Care Medicine receiving percutaneous tracheostomy due to long term ventilation are screened according to inclusion and exclusion criteria.
Details of study-procedures:
Bronchoscopy:
The bronchoscopy for percutaneous tracheostomy is done according to the standard operating procedure of the Dept. for Intensive Care Medicine. Furthermore, during this study the bronchoscopy is done by a physician with an experience of more than 200 bronchoscopies.
Percutaneous Tracheostomy:
The tracheostomy is performed according to the Ciaglia Blue Rhino method(Ciaglia Blue Rhino® G2, Cook Medical, Bloomington, IN, USA). After skin incision and an optional blunt dissection of the subcutaneous tissue, the trachea is cannulated between the 2nd and 3rd tracheal cartilage.
Visualization is provided by a conventional multi use bronchoscope or by a single use bronchoscope. Should visualization be insufficient by a single use bronchoscope backup is provided by a conventional multi use bronchoscope.
The tracheostomy is performed by an experienced fellow or attending physician. rating of visualization of tracheal structures and ventilation during percutaneous dilatational tracheostomy:
Rating (each item 1 to 4 points)
- Identification of: thyroid cartilage, cricoid cartilage, 1st-3rd tracheal cartilage:
1 Reliable identification; 2 Only cricoid cartilage and tracheal cartilages; 3 Only tracheal cartilages; 4 No vision on tracheal structures
- Visualization of tracheal circumference:
1 Complete; 2 circumference 1/3 to 2/3 of circumference; 3 Only small parts of trachea; 4 No vision on tracheal structures
- Monitoring puncture: midline + level below 1st or 2nd tracheal cartilage:
1 Reliable identification; 2 Midline sure Level uncertain, but below the 1st tracheal cartilage; 3 Level of puncture uncertain; 4 No vision on tracheal structures
- Monitoring dilatation Anterior wall and Pars membranacea (P.m.) visible:
1 Reliable identification; 2 P.m. only; 3 Only small parts of trachea visible, no control of P.m.; 4 No vision on tracheal structures
- Quality of Ventilation Before puncture and worst ventilation during PDT, respectively:
1 Minute ventilation (MV) as before starting tracheotomy; 2 MV < 2 L/min or oxygen saturation (SO2) 80-90% (>2minutes); 3 MV < 0,5l /min or SO2 70 - 79% (> 2 minutes); 4 MV = 0 or SO2 < 70% (> 2 minutes)
- Quality of the suction channel:
1 Uncomplicated suction of secretion; 2 suction only under flush; 3 suction only possible after multiple removing and flushing of the bronchoscope.; 4 suction not possible.
Consent: all patients or their legal surrogate give written informed consent.
Data protection: Data are anonymized.
- Conditions
- Respiratory Insufficiency
- Being tested
- Single Use Bronchoscopy for PDT, Conventional Multi Use Bronchoscopy for PDT
- Keywords
- tracheotomy, bronchoscopy, critical care
- Medical subject headings
- Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single Use Bronchoscopy for PDTDevice
optical guidance of percutaneous tracheotomy is done by single use bronchoscopy
Conventional Multi Use Bronchoscopy for PDTDevice
optical guidance of percutaneous tracheotomy is done by conventional multi use bronchoscopy
| Study group | Role | What they receive |
|---|---|---|
| Single Use Bronchoscopy | Experimental | optical guidance of percutaneous tracheotomy is done by single use bronchoscopy Receives: Device: Single Use Bronchoscopy for PDT |
| Conventional Multi Use Bronchoscopy | Active comparator | optical guidance of percutaneous tracheotomy is done by conventional multi use bronchoscopy Receives: Device: Conventional Multi Use Bronchoscopy for PDT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visualisation
visualisation through the single use bronchoscope of endotracheal landmark structures for tracheotomy and visualization of the needle insertion (according to score) Scale Name: Rating A) Identification of: thyroid cartilage, cricoid cartilage, 1st-3rd tracheal cartilage 1 Reliable identification; 2 Only cricoid cartilage and tracheal cartilages; 3 Only tracheal cartilages; 4 No vision on tracheal structures B) Visualization of tracheal circumference 1 Complete; 2 circumference 1/3 to 2/3 of circumference; 3 Only small parts of trachea; 4 No vision on tracheal structures C) Monitoring puncture: midline + level below 1st or 2nd tracheal cartilage
1 Reliable identification; 2 Midline sure Level uncertain, but below the 1st tracheal cartilage; 3 Level of puncture uncertain; 4 No vision on tracheal structures D) Monitoring dilatation Anterior wall and Pars membranacea (P.m.) visible; 1 Reliable identification; 2 P.m. only; 3 Only small parts of trachea visible, no control of P.
Measured: during tracheotomy
Secondary outcomes (10)
Minute ventilation
minute ventilation (according to score)
Scale Name: Quality of Ventilation
1 Minute ventilation (MV) as before starting tracheotomy; 2 MV < 2 L/min or oxygen saturation (SO2) 80-90% (>2minutes); 3 MV < 0,5l /min or SO2 70 - 79% (> 2 minutes); 4 MV = 0 or SO2 < 70% (> 2 minutes)
Measured: two time points: 1. during identification of landmark structures before puncture of trachea, 2. during puncture, dilatation and tracheotomy
Peak airway pressure
changes in peak airway pressure of ventilator if volume controlled mode is used
Measurement during following time Points:
- Measurements of Peak airway pressure before sterile drapes are applied; preintervention
- Measurement of Changes in Peak airway pressure before Skin incision and during identification of landmark structures
- Measure of Peak airway pressure after Insertion of the tracheal canula
Measured: three time points: baseline value (before sterile drapes are applied), 0 min before skin incision, and 0 min after insertion of tracheal cannula
pH
change in pH-values
Measurement during following time Points:
- Measurements of pH values before sterile drapes are applied; preintervention
- Measurement of Changes in pH values before Skin incision and during identification of landmark structures
- Measurement of pH values after Insertion of the tracheal canula
Measured: three time points: baseline value (before sterile drapes are applied), 0 min before skin incision, and 0 min after insertion of tracheal cannula
paO2
Change in paO2 values
Measurement during following time Points:
- Measurements of paO2 values before sterile drapes are applied; preintervention
- Measurement of Changes in paO2 values before Skin incision and during identification of landmark structures
- Measurement of paO2 values after Insertion of the tracheal canula
Measured: three time points: baseline value (before sterile drapes are applied), 0 min before skin incision, and 0 min after insertion of tracheal cannula
paCO2
Change in paCO2 values
Measurement during following time Points:
- Measurements of paCO2 values before sterile drapes are applied; preintervention
- Measurement of Changes in paCO2 values before Skin incision and during identification of landmark structures
- Measurement of paCO2 values after Insertion of the tracheal canula
Measured: three time points: baseline value (before sterile drapes are applied), 0 min before skin incision, and 0 min after insertion of tracheal cannula
etCO2
Change in etCO2 values
Measurement during following time Points:
- Measurements of etCO2 values before sterile drapes are applied; preintervention
- Measurement of Changes in etCO2 values before Skin incision and during identification of landmark structures
- Measurement of etCO2 values after Insertion of the tracheal canula
Measured: three time points: baseline value (before sterile drapes are applied), 0 min before skin incision, and 0 min after insertion of tracheal cannula
Duration of intervention
Duration of Intervention
Measurement of Duration of Intervention from Skin incision till Insertion of tracheal cannula (measured in minutes)
Measured: during tracheotomy (skin incision till insertion of tracheal cannula)
Poor visualisation
Poor visualisation with single use bronchoscopy Poor identification thyroid cartilage, cricoid cartilage, 1st-3rd tracheal cartilage : Only identification of tracheal cartilages; No vision possible on tracheal structures Poor visualization of tracheal circumference: Only visualisation of small parts of trachea; No vision on tracheal structures
Poor monitoring of puncture: midline + level below 1st or 2nd tracheal cartilage
: Level of puncture uncertain; No vision on tracheal structures Poor Monitoring of Dilatation: Only small parts of trachea visible, no control of P.m.; No vision on tracheal structures
Measured: during tracheotomy
Poor control
Poor control of the single use bronchoscope:
Intubation of only one bronchial Segment not possible; Intubation of more than one bronchial Segment not possible.
Measured: during tracheotomy
adverse events
any adverse events that are likely associated with tracheostomy
Measured: up to 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2019
- Study start15 May 2019
- Primary completion1 Nov 2019
- Study completion4 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Respiratory InsufficiencyStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Assignment
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jörn Grensemann, MD, Principal investigator, Dept. of Intensive Care Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03952247
- Sponsor's protocol ID
- TraSUB
- Acronym
- TraSUB
- Status last verified
- Nov 2019
- First submitted
- 28 Apr 2019
- Last updated
- 19 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Dreher M, Kluge S. [Airway devices in the intensive care unit]. Pneumologie. 2014 Jun;68(6):371-7. doi: 10.1055/s-0034-1365318. Epub 2014 Mar 25. German.
PubMed 24668495Ciaglia P, Firsching R, Syniec C. Elective percutaneous dilatational tracheostomy. A new simple bedside procedure; preliminary report. Chest. 1985 Jun;87(6):715-9. doi: 10.1378/chest.87.6.715.
PubMed 3996056Braune S, Kluge S. [Percutaneous dilatational tracheostomy]. Dtsch Med Wochenschr. 2011 Jun;136(23):1265-9. doi: 10.1055/s-0031-1280549. Epub 2011 May 31. No abstract available. German.
PubMed 21630175Vargas M, Sutherasan Y, Antonelli M, Brunetti I, Corcione A, Laffey JG, Putensen C, Servillo G, Pelosi P. Tracheostomy procedures in the intensive care unit: an international survey. Crit Care. 2015 Aug 13;19(1):291. doi: 10.1186/s13054-015-1013-7.
PubMed 26271742Grensemann J, Eichler L, Kahler S, Jarczak D, Simon M, Pinnschmidt HO, Kluge S. Bronchoscopy versus an endotracheal tube mounted camera for the peri-interventional visualization of percutaneous dilatational tracheostomy - a prospective, randomized trial (VivaPDT). Crit Care. 2017 Dec 29;21(1):330. doi: 10.1186/s13054-017-1901-0.
PubMed 29284503Baumann HJ, Kemei C, Kluge S. [Tracheostomy in the intensive care unit]. Pneumologie. 2010 Dec;64(12):769-76. doi: 10.1055/s-0030-1255743. Epub 2010 Sep 20. German.
PubMed 20857374Byhahn C, Wilke HJ, Halbig S, Lischke V, Westphal K. Percutaneous tracheostomy: ciaglia blue rhino versus the basic ciaglia technique of percutaneous dilational tracheostomy. Anesth Analg. 2000 Oct;91(4):882-6. doi: 10.1097/00000539-200010000-00021.
PubMed 11004042Linstedt U, Zenz M, Krull K, Hager D, Prengel AW. Laryngeal mask airway or endotracheal tube for percutaneous dilatational tracheostomy: a comparison of visibility of intratracheal structures. Anesth Analg. 2010 Apr 1;110(4):1076-82. doi: 10.1213/ANE.0b013e3181d27fb4.
PubMed 20357150Tariparast PA, Brockmann A, Hartwig R, Kluge S, Grensemann J. Percutaneous dilatational tracheostomy with single use bronchoscopes versus reusable bronchoscopes - a prospective randomized trial (TraSUB). BMC Anesthesiol. 2022 Apr 2;22(1):90. doi: 10.1186/s12871-022-01618-4.
PubMed 35366806
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Randomized Study in Ventilated Critically Ill Patients Receiving Percutaneous Tracheotomy. A Comparison of Periinterventional Visualization of Conventional Bronchoscopy and Single Use Bronchoscopy (TraSUB™)
- ClinicalTrials.gov ID
- NCT03952247
- Acronym / sponsor ID
- TraSUB / TraSUB
- Conditions
- Respiratory Insufficiency
- Keywords
- tracheotomy, bronchoscopy, critical care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Universitätsklinikum Hamburg-EppendorfUniversity, hospital or other
- Study start
- 15 May 2019 (actual)
- Primary completion
- 1 Nov 2019 (actual)
- Study completion
- 4 Nov 2019 (actual)
- First posted
- 16 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Optical guidance for percutaneous tracheostomy in intensive care is usually performed by conventional multi use bronchoscopy. Recently a single use bronchoscope has been introduced that allows for endotracheal visualization.
For feasibility evaluation, 23 patients in intensive care receive percutaneous tracheostomy with optical guidance by the Ambu® aScopeTM 4 bronchoscope and 23 patients in intensive care receive percutaneous tracheostomy with a conventional bronchoscope (Olympus BF Type P60). The primary end point is the visualization through the single use bronchoscope of endotracheal landmark structures for tracheostomy and visualization of the needle insertion (according to score, see detailed description).
Detailed description
Background Long-term ventilated critically ill patients often receive a tracheostomy to facilitate weaning from the ventilator and for prevention of secondary complications by the endotracheal tube. Besides surgical tracheostomy in which a muco-cutaneous fistula is prepared between trachea and outer skin, percutaneous tracheostomy (PDT) has been introduced, in which a cannula is being inserted into the trachea. After introduction of a guidewire, the trachea is then dilated. This intervention should be led by optical guidance, i. e. to verify the correct point of tracheal cannulation between the 2nd and 3rd tracheal cartilage and to minimize the risk for accidental injury to the membranous part of the trachea. Usually, optical guidance is performed by conventional multi use bronchoscopy. During bronchoscopy in ventilated patients, a drop in minute ventilation or an increase of carbon dioxide partial pressure with a consecutive respiratory acidosis may occur. Recently, a single use bronchoscope has been introduced that permits a continuous visualisation of the trachea on a monitor connected to the camera (Ambu® aScopeTM 4, Ambu, Ballerup, Denmark) . In this study, it is being evaluated whether the optical guidance during PDT can be performed by the Ambu® aScope 4. The advantage of a single use bronchoscope for percutaneous dilatative tracheostomy in comparison to a conventional reuseable bronchoscope is that there is no need for repair or decontamination after use.
Methods:
Design of Study/ No. of Patients:
Randomized, prospective study/ 46 patients With a sample size of 46 (randomized 1:1 in 2 groups of 23 each) a difference of 35% on a visualization score [6] may be seen with an α-error of 0,05 and a β-error of 1-0,8.
Procedures:
- screening for study inclusion according to inclusion and exclusion criteria.
- Percutaneous tracheostomy with Ciaglia Blue Rhino technique
- Visualization of PDT via a conventional multi use bronchoscope vs the aScopeTM 4 single use bronchoscope. study inclusion: All patients being treated in the Dept. of Intensive Care Medicine receiving percutaneous tracheostomy due to long term ventilation are screened according to inclusion and exclusion criteria.
Details of study-procedures:
Bronchoscopy:
The bronchoscopy for percutaneous tracheostomy is done according to the standard operating procedure of the Dept. for Intensive Care Medicine. Furthermore, during this study the bronchoscopy is done by a physician with an experience of more than 200 bronchoscopies.
Percutaneous Tracheostomy:
The tracheostomy is performed according to the Ciaglia Blue Rhino method(Ciaglia Blue Rhino® G2, Cook Medical, Bloomington, IN, USA). After skin incision and an optional blunt dissection of the subcutaneous tissue, the trachea is cannulated between the 2nd and 3rd tracheal cartilage.
Visualization is provided by a conventional multi use bronchoscope or by a single use bronchoscope. Should visualization be insufficient by a single use bronchoscope backup is provided by a conventional multi use bronchoscope.
The tracheostomy is performed by an experienced fellow or attending physician. rating of visualization of tracheal structures and ventilation during percutaneous dilatational tracheostomy:
Rating (each item 1 to 4 points)
- Identification of: thyroid cartilage, cricoid cartilage, 1st-3rd tracheal cartilage:
1 Reliable identification; 2 Only cricoid cartilage and tracheal cartilages; 3 Only tracheal cartilages; 4 No vision on tracheal structures
- Visualization of tracheal circumference:
1 Complete; 2 circumference 1/3 to 2/3 of circumference; 3 Only small parts of trachea; 4 No vision on tracheal structures
- Monitoring puncture: midline + level below 1st or 2nd tracheal cartilage:
1 Reliable identification; 2 Midline sure Level uncertain, but below the 1st tracheal cartilage; 3 Level of puncture uncertain; 4 No vision on tracheal structures
- Monitoring dilatation Anterior wall and Pars membranacea (P.m.) visible:
1 Reliable identification; 2 P.m. only; 3 Only small parts of trachea visible, no control of P.m.; 4 No vision on tracheal structures
- Quality of Ventilation Before puncture and worst ventilation during PDT, respectively:
1 Minute ventilation (MV) as before starting tracheotomy; 2 MV < 2 L/min or oxygen saturation (SO2) 80-90% (>2minutes); 3 MV < 0,5l /min or SO2 70 - 79% (> 2 minutes); 4 MV = 0 or SO2 < 70% (> 2 minutes)
- Quality of the suction channel:
1 Uncomplicated suction of secretion; 2 suction only under flush; 3 suction only possible after multiple removing and flushing of the bronchoscope.; 4 suction not possible.
Consent: all patients or their legal surrogate give written informed consent.
Data protection: Data are anonymized.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Parallel Assignment
| Arm | Type | Receives |
|---|---|---|
| Single Use Bronchoscopy | Experimental | Device: Single Use Bronchoscopy for PDToptical guidance of percutaneous tracheotomy is done by single use bronchoscopy |
| Conventional Multi Use Bronchoscopy | Active comparator | Device: Conventional Multi Use Bronchoscopy for PDToptical guidance of percutaneous tracheotomy is done by conventional multi use bronchoscopy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients receiving percutaneous tracheotomy in the Dept. of Intensive Care Medicine.
- Age ≥ 18 years
- Informed consent
Key exclusion criteria (3 listed)
- Age < 18 years
- No consent
- Direct laryngoscopy according to Cormack-Lehane ≥ 3
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 |
|---|---|---|
| Single Use Bronchoscopy for PDToptical guidance of percutaneous tracheotomy is done by single use bronchoscopy | Device | Single Use Bronchoscopy |
| Conventional Multi Use Bronchoscopy for PDToptical guidance of percutaneous tracheotomy is done by conventional multi use bronchoscopy | Device | Conventional Multi Use Bronchoscopy |
Primary outcome
Visualisation
Time frame: during tracheotomy
visualisation through the single use bronchoscope of endotracheal landmark structures for tracheotomy and visualization of the needle insertion (according to score) Scale Name: Rating A) Identification of: thyroid cartilage, cricoid cartilage, 1st-3rd tracheal cartilage 1 Reliable identification; 2 Only cricoid cartilage and tracheal cartilages; 3 Only tracheal cartilages; 4 No vision on tracheal structures B) Visualization of tracheal circumference 1 Complete; 2 circumference 1/3 to 2/3 of circumference; 3 Only small parts of trachea; 4 No vision on tracheal structures C) Monitoring puncture: midline + level below 1st or 2nd tracheal cartilage 1 Reliable identification; 2 Midline sure Level uncertain, but below the 1st tracheal cartilage; 3 Level of puncture uncertain; 4 No vision on tracheal structures D) Monitoring dilatation Anterior wall and Pars membranacea (P.m.) visible; 1 Reliable identification; 2 P.m. only; 3 Only small parts of trachea visible, no control of P.
10 secondary outcomes
Minute ventilation
Time frame: two time points: 1. during identification of landmark structures before puncture of trachea, 2. during puncture, dilatation and tracheotomy
Peak airway pressure
Time frame: three time points: baseline value (before sterile drapes are applied), 0 min before skin incision, and 0 min after insertion of tracheal cannula
pH
Time frame: three time points: baseline value (before sterile drapes are applied), 0 min before skin incision, and 0 min after insertion of tracheal cannula
paO2
Time frame: three time points: baseline value (before sterile drapes are applied), 0 min before skin incision, and 0 min after insertion of tracheal cannula
paCO2
Time frame: three time points: baseline value (before sterile drapes are applied), 0 min before skin incision, and 0 min after insertion of tracheal cannula
etCO2
Time frame: three time points: baseline value (before sterile drapes are applied), 0 min before skin incision, and 0 min after insertion of tracheal cannula
Duration of intervention
Time frame: during tracheotomy (skin incision till insertion of tracheal cannula)
Poor visualisation
Time frame: during tracheotomy
Poor control
Time frame: during tracheotomy
adverse events
Time frame: up to 1 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2019.
- Background: PubMed 24668495Dreher M, Kluge S. [Airway devices in the intensive care unit]. Pneumologie. 2014 Jun;68(6):371-7. doi: 10.1055/s-0034-1365318. Epub 2014 Mar 25. German.
- Background: PubMed 3996056Ciaglia P, Firsching R, Syniec C. Elective percutaneous dilatational tracheostomy. A new simple bedside procedure; preliminary report. Chest. 1985 Jun;87(6):715-9. doi: 10.1378/chest.87.6.715.
- Background: PubMed 21630175Braune S, Kluge S. [Percutaneous dilatational tracheostomy]. Dtsch Med Wochenschr. 2011 Jun;136(23):1265-9. doi: 10.1055/s-0031-1280549. Epub 2011 May 31. No abstract available. German.
- Background: PubMed 26271742Vargas M, Sutherasan Y, Antonelli M, Brunetti I, Corcione A, Laffey JG, Putensen C, Servillo G, Pelosi P. Tracheostomy procedures in the intensive care unit: an international survey. Crit Care. 2015 Aug 13;19(1):291. doi: 10.1186/s13054-015-1013-7.
- Background: PubMed 29284503Grensemann J, Eichler L, Kahler S, Jarczak D, Simon M, Pinnschmidt HO, Kluge S. Bronchoscopy versus an endotracheal tube mounted camera for the peri-interventional visualization of percutaneous dilatational tracheostomy - a prospective, randomized trial (VivaPDT). Crit Care. 2017 Dec 29;21(1):330. doi: 10.1186/s13054-017-1901-0.
- Background: PubMed 20857374Baumann HJ, Kemei C, Kluge S. [Tracheostomy in the intensive care unit]. Pneumologie. 2010 Dec;64(12):769-76. doi: 10.1055/s-0030-1255743. Epub 2010 Sep 20. German.
- Background: PubMed 11004042Byhahn C, Wilke HJ, Halbig S, Lischke V, Westphal K. Percutaneous tracheostomy: ciaglia blue rhino versus the basic ciaglia technique of percutaneous dilational tracheostomy. Anesth Analg. 2000 Oct;91(4):882-6. doi: 10.1097/00000539-200010000-00021.
- Background: PubMed 20357150Linstedt U, Zenz M, Krull K, Hager D, Prengel AW. Laryngeal mask airway or endotracheal tube for percutaneous dilatational tracheostomy: a comparison of visibility of intratracheal structures. Anesth Analg. 2010 Apr 1;110(4):1076-82. doi: 10.1213/ANE.0b013e3181d27fb4.
- Derived from this study: PubMed 35366806Tariparast PA, Brockmann A, Hartwig R, Kluge S, Grensemann J. Percutaneous dilatational tracheostomy with single use bronchoscopes versus reusable bronchoscopes - a prospective randomized trial (TraSUB). BMC Anesthesiol. 2022 Apr 2;22(1):90. doi: 10.1186/s12871-022-01618-4.
- 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.
Jörn Grensemann, MD principal investigator
Dept. of Intensive Care 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 Single Use Bronchoscopy for PDT and Conventional Multi Use Bronchoscopy for PDT in people with Respiratory Insufficiency, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
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 3 inclusion and 3 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: finished, as of the sponsor's last update on 19 Nov 2019. 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 Germany. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Visualisation (time frame: during tracheotomy). 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 NCT03952247, which also lists 9 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 19 Nov 2019.