Tracheal IntubationETView1NCT02040961
Assessment of the the ETView Double-lumen Tube
A study testing ETView Double-Lumen Tube in people with Tracheal Intubation, run by Hopital Foch at 1 site in France.
Trial summary
The double tube ETView is particularly innovative as it includes an integrated optical fiber to visualize the carena. This study aims to verify if if its use avoids the requirement of a fibreoptic bronchoscopy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tracheal Intubation
- What is being tested?
- ETView Double-Lumen Tube
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2013to May 2014
- 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
- elective thoracic surgery with anticipated use of a DLT
Who cannot join
- left pneumonectomy or left lobectomy requiring an anastomosis on the left main bronchus
- proximal left bronchial lesion
- anatomical abnormality of the bronchial tree
- suspicion of difficult mask ventilation or intubation
Trial locations and contacts
1 site in 1 country.
About this study
The double tube ETView is particularly innovative as it includes an integrated optical fiber to visualize the carena. This study aims to verify if if its use avoids the requirement of a fibreoptic bronchoscopy.
- Conditions
- Tracheal Intubation
- Being tested
- ETView Double-Lumen Tube
- Keywords
- Patients, Undergoing, Elective, Thoracic, Surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ETView Double-Lumen TubeDevice
Tracheal intubation is performed using a ETView Double-Lumen Tube
| Study group | Role | What they receive |
|---|---|---|
| EtView | Experimental | Use of ETVew double-lumen tube Receives: Device: ETView Double-Lumen Tube |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of insertion
Rate of insertion, defined as successful placement of airway device in correct position without help of fibreoptic bronchoscopy
Measured: 300 seconds
Secondary outcomes (5)
Ease of use evaluated by the anesthesiologist
Evaluation using a score (1 = easy to use, 2 = not so easy, 3 = difficult)
Measured: 3 hours
Quality of lung collapse
Evaluation using a score (1 = atelectatic lung, 2 = lung well isolated but not atelectatic, 3 = failure of lung isolation)
Measured: 3 hours
Rate of misplacement occurring after patients removal from dorsal to lateral position
Measured: 1 hour
Rate of misplacement, occurring during surgery
Measured: 3 hours
Rate of requirement to a conventional double lumen tube
ETView Double-Lumen Tube is not well positioned. It is withdrawn and replaced by a conventional double lumen tube
Measured: 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2014 (estimated)
- Study startSep 2013
- Primary completionMay 2014
- Study completionMay 2014
Why it stopped: An incident, burned tube, happened before intubation. The promoter decided to stop the study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tracheal IntubationStudies 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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hopital Foch
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Virginie Dumans-Nizard, MD, Principal investigator, Hôpital Foch
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02040961
- Sponsor's protocol ID
- 2012/64
- Other IDs
- 2012-A01552-41
- Acronym
- ETView1
- Status last verified
- Oct 2016
- First submitted
- 16 Jan 2014
- Last updated
- 31 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the the ETView Double-lumen Tube
- ClinicalTrials.gov ID
- NCT02040961
- Acronym / sponsor ID
- ETView1 / 2012/64
- Conditions
- Tracheal Intubation
- Keywords
- Patients, Undergoing, Elective, Thoracic, Surgery
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: An incident, burned tube, happened before intubation. The promoter decided to stop the study.
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Hopital FochUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 20 Jan 2014 (estimated)
- 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.
The double tube ETView is particularly innovative as it includes an integrated optical fiber to visualize the carena. This study aims to verify if if its use avoids the requirement of a fibreoptic bronchoscopy.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EtView | Experimental | Device: ETView Double-Lumen TubeUse of ETVew double-lumen tube |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- elective thoracic surgery with anticipated use of a DLT
Key exclusion criteria (4 listed)
- left pneumonectomy or left lobectomy requiring an anastomosis on the left main bronchus
- proximal left bronchial lesion
- anatomical abnormality of the bronchial tree
- suspicion of difficult mask ventilation or intubation
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 |
|---|---|---|
| ETView Double-Lumen TubeTracheal intubation is performed using a ETView Double-Lumen Tube | Device | EtView |
Primary outcome
Rate of insertion
Time frame: 300 seconds
Rate of insertion, defined as successful placement of airway device in correct position without help of fibreoptic bronchoscopy
5 secondary outcomes
Ease of use evaluated by the anesthesiologist
Time frame: 3 hours
Quality of lung collapse
Time frame: 3 hours
Rate of misplacement occurring after patients removal from dorsal to lateral position
Time frame: 1 hour
Rate of misplacement, occurring during surgery
Time frame: 3 hours
Rate of requirement to a conventional double lumen tube
Time frame: 3 hours
Results and safety
The study was stopped early (reason given: An incident, burned tube, happened before intubation. The promoter decided to stop the study.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2016.
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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.
Virginie Dumans-Nizard, MD principal investigator
Hôpital Foch
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ETView Double-Lumen Tube in people with Tracheal Intubation, run by Hopital Foch at 1 site in France.
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 1 inclusion and 4 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 31 Oct 2016. 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 France. 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 was stopped early (reason given: An incident, burned tube, happened before intubation. The promoter decided to stop the study.). Results are not available in the source record.
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?
Rate of insertion (time frame: 300 seconds). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Oct 2016.