"TRAcheostomy With Single Use Bronchoscopes vs. Conventional Bronchoscopes" (TraSUB)

November 16, 2019 updated by: Universitätsklinikum Hamburg-Eppendorf

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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)

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.m.; 4 No vision on tracheal structures

E) 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)

F) 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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
46

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • HH
      • Hamburg, HH, Germany, 20246
        • Universitätsklinikum Hamburg-Eppendorf

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients receiving percutaneous tracheotomy in the Dept. of Intensive Care Medicine.
  • Age ≥ 18 years
  • Informed consent

Exclusion Criteria:

  • Age < 18 years
  • No consent
  • Direct laryngoscopy according to Cormack-Lehane ≥ 3

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Single Use Bronchoscopy
optical guidance of percutaneous tracheotomy is done by single use bronchoscopy
Device: Single Use Bronchoscopy for PDT
optical guidance of percutaneous tracheotomy is done by single use bronchoscopy
ACTIVE_COMPARATOR: Conventional Multi Use Bronchoscopy
optical guidance of percutaneous tracheotomy is done by conventional multi use bronchoscopy
Device: Conventional Multi Use Bronchoscopy for PDT
optical guidance of percutaneous tracheotomy is done by conventional multi use bronchoscopy

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
during tracheotomy

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Minute ventilation
Time Frame: two time points: 1. during identification of landmark structures before puncture of trachea, 2. during puncture, dilatation and tracheotomy

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)
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

changes in peak airway pressure of ventilator if volume controlled mode is used

Measurement during following time Points:

  1. Measurements of Peak airway pressure before sterile drapes are applied; preintervention
  2. Measurement of Changes in Peak airway pressure before Skin incision and during identification of landmark structures
  3. Measure of Peak airway pressure after Insertion of the tracheal canula
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

change in pH-values

Measurement during following time Points:

  1. Measurements of pH values before sterile drapes are applied; preintervention
  2. Measurement of Changes in pH values before Skin incision and during identification of landmark structures
  3. Measurement of pH values after Insertion of the tracheal canula
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

Change in paO2 values

Measurement during following time Points:

  1. Measurements of paO2 values before sterile drapes are applied; preintervention
  2. Measurement of Changes in paO2 values before Skin incision and during identification of landmark structures
  3. Measurement of paO2 values after Insertion of the tracheal canula
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

Change in paCO2 values

Measurement during following time Points:

  1. Measurements of paCO2 values before sterile drapes are applied; preintervention
  2. Measurement of Changes in paCO2 values before Skin incision and during identification of landmark structures
  3. Measurement of paCO2 values after Insertion of the tracheal canula
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

Change in etCO2 values

Measurement during following time Points:

  1. Measurements of etCO2 values before sterile drapes are applied; preintervention
  2. Measurement of Changes in etCO2 values before Skin incision and during identification of landmark structures
  3. Measurement of etCO2 values after Insertion of the tracheal canula
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)

Duration of Intervention

Measurement of Duration of Intervention from Skin incision till Insertion of tracheal cannula (measured in minutes)
during tracheotomy (skin incision till insertion of tracheal cannula)
Poor visualisation
Time Frame: during tracheotomy

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
during tracheotomy
Poor control
Time Frame: during tracheotomy

Poor control of the single use bronchoscope:

Intubation of only one bronchial Segment not possible; Intubation of more than one bronchial Segment not possible.
during tracheotomy
adverse events
Time Frame: up to 1 week
any adverse events that are likely associated with tracheostomy
up to 1 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Universitätsklinikum Hamburg-Eppendorf

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jörn Grensemann, MD, Dept. of Intensive Care Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 15, 2019

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2019

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 4, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 28, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 13, 2019

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 16, 2019

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 19, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 16, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TraSUB

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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