VideolaryngoscopyNCT04128982
Vidéolaryngoscopy Study of the LPEC in Obese Patients
An observational study of Videolaryngoscopy, run by University of Liege at 1 site in Belgium.
Trial summary
1. Check the intubation conditions during laryngoscopy without external mobilization of the larynx, with Sellick manoeuvre or with low paratracheal esophagal compression in obese patient 2. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Videolaryngoscopy
- What is being tested?
- mobilization of the larynx
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteBelgium
- Study dates
- 5 Nov 2019to 1 Sep 2020
- Phase
- Observational
- 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 to 80 years
- All sexes
- Adult, Older adult
Study population: Adults patients obese
Who may be able to join
- Adults patients with BMI > 35 undergoing general anaesthesia
Who cannot join
- pregnant women
- people with facial
- oropharyngeal abnormalities
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Impact of Sellick's Manoeuvre or Para-tracheal Compression of the Cervical Esophagus on Laryngeal Mass Movement and Vocal Cord Visualization in Obese Patients.
- Check the intubation conditions during laryngoscopy without external mobilization of the larynx, with Sellick manoeuvre or with low paratracheal esophagal compression in obese patient
- International surveys comparing tracheal intubation difficulty on a scale of 1 to 3 between cricoid pressure, Left Paratracheal Esophageal Compression and neutral position
Read the detailed description
Check the intubation conditions during laryngoscopy without external mobilization of the larynx, with Sellick manoeuvre or with low paratracheal esophagal compression in obese patient
International surveys comparing tracheal intubation difficulty on a scale of 1 to 3 between cricoid pressure, Left Paratracheal Esophageal Compression and neutral position
- Conditions
- Videolaryngoscopy
- Being tested
- mobilization of the larynx
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mobilization of the larynxProcedure or surgery
Check the intubation conditions during laryngoscopy without external mobilization of the larynx, with Sellick manoeuvre or with low paratracheal esophagal compression in 2 groups: patient in dorsal decubitus or Rapid Airway Management Positioner.
| Study group | Role | What they receive |
|---|---|---|
| Videolaryngoscopy | Check the intubation conditions during laryngoscopy without external mobilization of the larynx, with Sellick manoeuvre or with low paratracheal esophagal compression in 2 groups: patient in dorsal decubitus or Rapid Airway Management Positioner. Receives: Procedure: mobilization of the larynx |
What is being measured
The primary outcome is the main question the study is designed to answer.
Distance between oesophagus and trachea
Distance between oesophagus and trachea
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 posted16 Oct 2019
- Study start5 Nov 2019
- Primary completion1 Aug 2020
- Study completion1 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VideolaryngoscopyStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Liege
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Benjamin Javillier, University of Liege
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04128982
- Sponsor's protocol ID
- LPECOBESITY
- Status last verified
- Oct 2020
- First submitted
- 14 Oct 2019
- Last updated
- 6 Oct 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 6 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Impact of Sellick's Manoeuvre or Para-tracheal Compression of the Cervical Esophagus on Laryngeal Mass Movement and Vocal Cord Visualization in Obese Patients.
- ClinicalTrials.gov ID
- NCT04128982
- Acronym / sponsor ID
- LPECOBESITY
- Conditions
- Videolaryngoscopy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of LiegeUniversity, hospital or other
- Study start
- 5 Nov 2019 (actual)
- Primary completion
- 1 Aug 2020 (actual)
- Study completion
- 1 Sep 2020 (actual)
- First posted
- 16 Oct 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.
- Check the intubation conditions during laryngoscopy without external mobilization of the larynx, with Sellick manoeuvre or with low paratracheal esophagal compression in obese patient
- International surveys comparing tracheal intubation difficulty on a scale of 1 to 3 between cricoid pressure, Left Paratracheal Esophageal Compression and neutral position
Detailed description
Check the intubation conditions during laryngoscopy without external mobilization of the larynx, with Sellick manoeuvre or with low paratracheal esophagal compression in obese patient
International surveys comparing tracheal intubation difficulty on a scale of 1 to 3 between cricoid pressure, Left Paratracheal Esophageal Compression and neutral position
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Videolaryngoscopy | – | Procedure: mobilization of the larynxCheck the intubation conditions during laryngoscopy without external mobilization of the larynx, with Sellick manoeuvre or with low paratracheal esophagal compression in 2 groups: patient in dorsal decubitus or Rapid Airway Management Positioner. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Adults patients obese
Key inclusion criteria (1 listed)
- Adults patients with BMI > 35 undergoing general anaesthesia
Key exclusion criteria (3 listed)
- pregnant women
- people with facial
- oropharyngeal abnormalities
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 |
|---|---|---|
| mobilization of the larynxCheck the intubation conditions during laryngoscopy without external mobilization of the larynx, with Sellick manoeuvre or with low paratracheal esophagal compression in 2 groups: patient in dorsal decubitus or Rapid Airway Management Positioner. | Procedure or surgery | Videolaryngoscopy |
Primary outcome
Distance between oesophagus and trachea
Time frame: During laryngoscopy
Distance between oesophagus and trachea
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 6 Oct 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Videolaryngoscopy, 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 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 6 Oct 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. 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?
Distance between oesophagus and trachea (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 6 Oct 2020.