Laryngeal Mask MalpositionLPIMRICHNCT02940652
Laryngeal Mask Position in Magnetic Resonance Imaging in Children
An observational study of Laryngeal Mask Malposition, run by Brno University Hospital at 1 site in Czechia.
Trial summary
The aim of the trial is to obtain and to describe the position of the laryngeal mask during elective magnetic resonance imaging in paediatric patient. The radiologic findings will be compared to the clinical performance of the laryngeal mask. Read more about this study
- Who is it for?
- Ages 28 days to 19 years
- Conditions the study is for
- Laryngeal Mask Malposition
- What is being tested?
- Magnetic resonance imaging
- Type of treatment
- Surgery or procedure
- How many people
- 220 participants
- Where
- 1 siteCzechia
- Study dates
- Oct 2016to May 2017
- 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 28 days to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Paediatric patients undergoing elective magnetic resonance imaging of the head (brain) and/or head (brain) and cervical spine
Who may be able to join
- paediatric patient undergoing elective MRI scanning - brain and/or brain and cervical spine
- laryngeal mask inserted for airway management during anesthesia
- age between 29 days and 19 years
Who cannot join
- outside the age limit
- laryngeal mask contraindication - gastroesophageal reflux disease, ileus, full stomach, impairment of the haemodynamics
Trial locations and contacts
1 site in 1 country.
Czechia1 site
University Hospital Brno
Brno, Jihomoravský Kraj, Czech Republic, 62500
About this study
Official title: Position of Laryngeal Mask in Paediatric Patients During Magnetic Resonance Imaging: Prospective Observational Cohort Study
The aim of the trial is to obtain and to describe the position of the laryngeal mask during elective magnetic resonance imaging in paediatric patient. The radiologic findings will be compared to the clinical performance of the laryngeal mask.
Read the detailed description
Properly inserted laryngeal mask (LMA) with good clinical performance can be misplaced (on radiological imaging) but with not know effect on clinical practice. The percentage of the misplaced LMAs are relatively high, but the exact number in paediatric population is currently not clear. The aim of this prospective observational cohort study is to describe the percentage of misplaced LMAs during elective magnetic resonance imaging (MRI) in paediatric patient. After approval of the local ethical committee all elective paediatric patients in study interval (10/2016-3/2017) indicated for elective MRI of the brain or elective MRI of the brain and cervical spine will be included to the trial. Demographic characteristics - age, weight, comorbidities, anesthesia management - education of anesthesiologist, type of LMA, number of insertion attempts, clinical performance of the LMA, presence/absence of leak, the peak inspiratory pressure (mechanical ventilation), volume of air in cuff, complications during anesthesia and LMA soil after extraction - blood, saliva, mucus, gastric content. The clinical performance will be compared to the LMA position on MRI - position of the proximal and the distal site of the LMA cuff according to the cervical vertebrae, displacement of the epiglottis, distance between proximal LMA cuff and vocal cords, distance between distal LMA cuff and vocal cords.
- Conditions
- Laryngeal Mask Malposition
- Being tested
- Magnetic resonance imaging
- Keywords
- Laryngeal mask,MRI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic resonance imagingRadiation
Also called MRI
No intervention - description of the position of the LMA obtained during routine elective MRI scanning of the brain and/or cervical spine
| Study group | Role | What they receive |
|---|---|---|
| Paediatric patients undergoing MRI scanning | All paediatric patients undergoing elective MRI scanning of the brain and/or brain and cervical spine Receives: Radiation: Magnetic resonance imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Displacement of the laryngeal mask on the MRI imaging
position of the proximal and the distal site of the LMA cuff according to the cervical vertebrae distance between proximal LMA cuff and vocal cords
Measured: 6 months
Secondary outcomes (2)
Clinical performance of the LMA
complications associated with airway management
Measured: 6 months
Demographic characteristics
age, weight, comorbidities
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2016 (estimated)
- Study startOct 2016
- Primary completionMay 2017
- Study completionMay 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Laryngeal Mask MalpositionStudies 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
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brno University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Petr Štourač, MD, Brno University Hospital
- Investigators
- Petr Štourač, doc.MD.Ph.D, Study director, Brno University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02940652
- Sponsor's protocol ID
- KDAR FN Brno 2016
- Acronym
- LPIMRICH
- Status last verified
- Nov 2018
- First submitted
- 18 Oct 2016
- Last updated
- 19 Nov 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Klucka J, Senkyrik J, Skotakova J, Stoudek R, Toukalkova M, Krikava I, Marecek L, Pavlik T, Stouracova A, Stourac P. Laryngeal mask airway Unique position in paediatric patients undergoing magnetic resonance imaging (MRI): prospective observational study. BMC Anesthesiol. 2018 Oct 24;18(1):153. doi: 10.1186/s12871-018-0617-2.
PubMed 30355285
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Position of Laryngeal Mask in Paediatric Patients During Magnetic Resonance Imaging: Prospective Observational Cohort Study
- ClinicalTrials.gov ID
- NCT02940652
- Acronym / sponsor ID
- LPIMRICH / KDAR FN Brno 2016
- Conditions
- Laryngeal Mask Malposition
- Keywords
- Laryngeal mask,MRI
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- Brno University HospitalUniversity, hospital or other
- Study start
- Oct 2016
- Primary completion
- May 2017 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 21 Oct 2016 (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 aim of the trial is to obtain and to describe the position of the laryngeal mask during elective magnetic resonance imaging in paediatric patient. The radiologic findings will be compared to the clinical performance of the laryngeal mask.
Detailed description
Properly inserted laryngeal mask (LMA) with good clinical performance can be misplaced (on radiological imaging) but with not know effect on clinical practice. The percentage of the misplaced LMAs are relatively high, but the exact number in paediatric population is currently not clear. The aim of this prospective observational cohort study is to describe the percentage of misplaced LMAs during elective magnetic resonance imaging (MRI) in paediatric patient. After approval of the local ethical committee all elective paediatric patients in study interval (10/2016-3/2017) indicated for elective MRI of the brain or elective MRI of the brain and cervical spine will be included to the trial. Demographic characteristics - age, weight, comorbidities, anesthesia management - education of anesthesiologist, type of LMA, number of insertion attempts, clinical performance of the LMA, presence/absence of leak, the peak inspiratory pressure (mechanical ventilation), volume of air in cuff, complications during anesthesia and LMA soil after extraction - blood, saliva, mucus, gastric content. The clinical performance will be compared to the LMA position on MRI - position of the proximal and the distal site of the LMA cuff according to the cervical vertebrae, displacement of the epiglottis, distance between proximal LMA cuff and vocal cords, distance between distal LMA cuff and vocal cords.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Paediatric patients undergoing MRI scanning | – | Radiation: Magnetic resonance imagingAll paediatric patients undergoing elective MRI scanning of the brain and/or brain and cervical spine |
Who may qualify
- Ages
- 28 days to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Paediatric patients undergoing elective magnetic resonance imaging of the head (brain) and/or head (brain) and cervical spine
Key inclusion criteria (3 listed)
- paediatric patient undergoing elective MRI scanning - brain and/or brain and cervical spine
- laryngeal mask inserted for airway management during anesthesia
- age between 29 days and 19 years
Key exclusion criteria (2 listed)
- outside the age limit
- laryngeal mask contraindication - gastroesophageal reflux disease, ileus, full stomach, impairment of the haemodynamics
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 |
|---|---|---|
| Magnetic resonance imagingAlso: MRINo intervention - description of the position of the LMA obtained during routine elective MRI scanning of the brain and/or cervical spine | Radiation | Paediatric patients undergoing MRI scanning |
Primary outcome
Displacement of the laryngeal mask on the MRI imaging
Time frame: 6 months
position of the proximal and the distal site of the LMA cuff according to the cervical vertebrae distance between proximal LMA cuff and vocal cords
2 secondary outcomes
Clinical performance of the LMA
Time frame: 6 months
Demographic characteristics
Time frame: 6 months
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 19 Nov 2018.
- Derived from this study: PubMed 30355285Klucka J, Senkyrik J, Skotakova J, Stoudek R, Toukalkova M, Krikava I, Marecek L, Pavlik T, Stouracova A, Stourac P. Laryngeal mask airway Unique position in paediatric patients undergoing magnetic resonance imaging (MRI): prospective observational study. BMC Anesthesiol. 2018 Oct 24;18(1):153. doi: 10.1186/s12871-018-0617-2.
- Full text open accessLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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.
Petr Štourač, doc.MD.Ph.D study director
Brno University Hospital
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 Laryngeal Mask Malposition, run by Brno University Hospital at 1 site in Czechia.
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 3 inclusion and 2 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 19 Nov 2018. 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 Czechia. 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?
Displacement of the laryngeal mask on the MRI imaging (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02940652, which also lists 1 linked publication.
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 Nov 2018.