Endotracheal IntubationNCT01279564
Comparison Between Etview Tracheoscopic Ventilation Tube - TVT to Standard Endotracheal Intubation
A study testing ETview TVT endotracheal tube and Endotracheal tube in people with Endotracheal Intubation, run by Rambam Health Care Campus at 1 site in Israel.
Trial summary
Airway management is one of the most important tasks facing the physician, especially the anesthesiologist. Fast and correct performance of endotracheal intubations done as normal routine in the operating room, but can save life everywhere. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Endotracheal Intubation
- What is being tested?
- ETview TVT endotracheal tube and Endotracheal tube
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteIsrael
- Study dates
- Feb 2011to Dec 2011
- 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 patients scheduled for elective surgery under general anesthesia with endotracheal intubation
Who cannot join
- Age under 18 years
- ASA greater than 3
- Lip, oral or airway infection
- Coagulopathy
- Indication to perform Sellick's maneuver for increased risk of aspiration
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison Between Etview Tracheoscopic Ventilation Tube - TVT to Standard Endotracheal Intubation During Regular and Difficult Intubation
Airway management is one of the most important tasks facing the physician, especially the anesthesiologist. Fast and correct performance of endotracheal intubations done as normal routine in the operating room, but can save life everywhere.
To make intubation easier, several newly designed tubes and laryngoscopes are developed and tested every year. Their performance is evaluated subjectively by the acting anesthesiologist, and by using objective parameters such as speed of intubation, the force applied during laryngoscopy , or catecholamines secretion during intubation as a stress parameter . The studies set for testing these parameters lead to establish accepted indications for the treatment of the airway in cases of anticipated and unanticipated difficult airway.
In the present study we will compare the performance parameters of intubation using Etview Tracheoscopic Ventilation Tube - TVT to the standard tube, of which most of daily intubations are carried with. The Etview TVT is similar to the standard endotracheal tube; its outer dimensions and material is exactly as the standard tube, the difference is only the inner fiber of the camera.
- Conditions
- Endotracheal Intubation
- Being tested
- ETview TVT endotracheal tube, Endotracheal tube
- Keywords
- Endotracheal intubation and its outcomes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ETview TVT endotracheal tubeDevice
intubation
Endotracheal tubeDevice
Intubation
| Study group | Role | What they receive |
|---|---|---|
| ETview | Experimental | ETview TVT endotracheal tube Receives: Device: ETview TVT endotracheal tube |
| Control | Sham comparator | Endotracheal tube Receives: Device: Endotracheal tube |
What is being measured
The primary outcome is the main question the study is designed to answer.
In the Present Study we Will Compare the Performance Parameters of Intubation Using Etview Tracheoscopic Ventilation Tube - TVT to the Standard Tube
Measured: 1 year
Duration of Endotracheal Intubation
Time between introducing the laryngoscope and inflation of tube's cuff
Measured: The induction of general anesthesia, on the operating day (first day)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2011 (estimated)
- Study startFeb 2011
- Primary completionDec 2011
- Study completionDec 2011
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.
- Other trials for Endotracheal 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rambam Health Care Campus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michal Barak, MD, Principal investigator, Rambam Health Care Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01279564
- Sponsor's protocol ID
- 181-09CTIL
- Other IDs
- 0181-RMB
- Status last verified
- Jun 2016
- First submitted
- 17 Jan 2011
- Last updated
- 27 Jul 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Etview Tracheoscopic Ventilation Tube - TVT to Standard Endotracheal Intubation During Regular and Difficult Intubation
- ClinicalTrials.gov ID
- NCT01279564
- Acronym / sponsor ID
- 181-09CTIL
- Conditions
- Endotracheal Intubation
- Keywords
- Endotracheal intubation and its outcomes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Rambam Health Care CampusUniversity, hospital or other
- Study start
- Feb 2011
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 19 Jan 2011 (estimated)
- Results
- Posted 11 Nov 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Airway management is one of the most important tasks facing the physician, especially the anesthesiologist. Fast and correct performance of endotracheal intubations done as normal routine in the operating room, but can save life everywhere.
To make intubation easier, several newly designed tubes and laryngoscopes are developed and tested every year. Their performance is evaluated subjectively by the acting anesthesiologist, and by using objective parameters such as speed of intubation, the force applied during laryngoscopy , or catecholamines secretion during intubation as a stress parameter . The studies set for testing these parameters lead to establish accepted indications for the treatment of the airway in cases of anticipated and unanticipated difficult airway.
In the present study we will compare the performance parameters of intubation using Etview Tracheoscopic Ventilation Tube - TVT to the standard tube, of which most of daily intubations are carried with. The Etview TVT is similar to the standard endotracheal tube; its outer dimensions and material is exactly as the standard tube, the difference is only the inner fiber of the camera.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ETview | Experimental | Device: ETview TVT endotracheal tubeETview TVT endotracheal tube |
| Control | Sham comparator | Device: Endotracheal tubeEndotracheal tube |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients scheduled for elective surgery under general anesthesia with endotracheal intubation
Key exclusion criteria (5 listed)
- Age under 18 years
- ASA greater than 3
- Lip, oral or airway infection
- Coagulopathy
- Indication to perform Sellick's maneuver for increased risk of aspiration
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 TVT endotracheal tubeintubation | Device | ETview |
| Endotracheal tubeIntubation | Device | Control |
Primary outcome
In the Present Study we Will Compare the Performance Parameters of Intubation Using Etview Tracheoscopic Ventilation Tube - TVT to the Standard Tube
Time frame: 1 year
Duration of Endotracheal Intubation
Time frame: The induction of general anesthesia, on the operating day (first day)
Time between introducing the laryngoscope and inflation of tube's cuff
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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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.
Michal Barak, MD principal investigator
Rambam Health Care Campus
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 TVT endotracheal tube and Endotracheal tube in people with Endotracheal Intubation, run by Rambam Health Care Campus at 1 site in Israel.
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 5 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 27 Jul 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 Israel. 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. Some participants in this study may receive a placebo. 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 11 Nov 2014). 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?
In the Present Study we Will Compare the Performance Parameters of Intubation Using Etview Tracheoscopic Ventilation Tube - TVT to the Standard Tube (time frame: 1 year). 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?
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 27 Jul 2016.