Intubation;DifficultNCT04438772
Effect of LPEC Compared With a Sham Procedure in the General Anesthesia
A study of Intubation;Difficult, run by University of Liege at 1 site in Belgium.
Trial summary
Check the condition of intubation with LPEC compared with a sham procedure in the general anesthesia Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intubation;Difficult
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Jun 2020to 1 Nov 2020
- 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
- Intubation
Who cannot join
- ENT neoplasia
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
Javillier
Liège, 4000
Benjamin Javillier, MD, 003243667180, benjamin.javillier@chuliege.be
About this study
Check the condition of intubation with LPEC compared with a sham procedure in the general anesthesia
- Conditions
- Intubation;Difficult
- Being tested
- Check the condition of intubation with LPEC compared with a sham procedure in the general anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Check the condition of intubation with LPEC compared with a sham procedure in the general anesthesiaOther
Intubation with Left Paratracheal Esophagus Compression (LPEC) or sham procedure and evaluation of intubation's condition
| Study group | Role | What they receive |
|---|---|---|
| LPEC | Experimental | Not described Receives: Other: Check the condition of intubation with LPEC compared with a sham procedure in the general anesthesia |
| Sham procedure | Sham comparator | Not described Receives: Other: Check the condition of intubation with LPEC compared with a sham procedure in the general anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cormack score
from 0 to 4
Measured: During laryngoscopy
Secondary outcomes (1)
Time to intubation
Measured: During laryngoscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2020
- Study start1 Jun 2020
- Primary completion1 Oct 2020 (estimated)
- Study completion1 Nov 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intubation;DifficultStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Liege
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Benjamin Javillier, University of Liege
- Investigators
- Benjamin Javillier, MD, Principal investigator, University of Liege
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04438772
- Sponsor's protocol ID
- LPEConditions
- Status last verified
- Jun 2020
- First submitted
- 15 Jun 2020
- Last updated
- 19 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of LPEC Compared With a Sham Procedure in the General Anesthesia
- ClinicalTrials.gov ID
- NCT04438772
- Acronym / sponsor ID
- LPEConditions
- Conditions
- Intubation;Difficult
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of LiegeUniversity, hospital or other
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 1 Oct 2020 (estimated)
- Study completion
- 1 Nov 2020 (estimated)
- First posted
- 19 Jun 2020 (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.
Check the condition of intubation with LPEC compared with a sham procedure in the general anesthesia
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LPEC | Experimental | Other: Check the condition of intubation with LPEC compared with a sham procedure in the general anesthesia |
| Sham procedure | Sham comparator | Other: Check the condition of intubation with LPEC compared with a sham procedure in the general anesthesia |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Intubation
Key exclusion criteria (1 listed)
- ENT neoplasia
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 |
|---|---|---|
| Check the condition of intubation with LPEC compared with a sham procedure in the general anesthesiaIntubation with Left Paratracheal Esophagus Compression (LPEC) or sham procedure and evaluation of intubation's condition | Other | LPEC, Sham procedure |
Primary outcome
Cormack score
Time frame: During laryngoscopy
from 0 to 4
1 secondary outcome
Time to intubation
Time frame: During laryngoscopy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2020.
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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.
Benjamin Javillier, MD principal investigator
University of Liege
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Intubation;Difficult, run by University of Liege at 1 site in Belgium.
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 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: status not confirmed, as of the sponsor's last update on 19 Jun 2020. 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 Belgium. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Benjamin Javillier, MD (003243667180, benjamin.javillier@chuliege.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cormack score (time frame: During laryngoscopy). 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 19 Jun 2020.