the Position of Laryngeal Mask AirwayPhase 1NCT04090944
Comparison Between Blind And Ultrasound Guided Laryngeal Mask Airway Insertion
A Phase 1 study testing the fiberoptic laryngoscope (KARL STORZ 11301BN1, Germany) for confirmation of LMA position in people with the Position of Laryngeal Mask Airway, run by Beni-Suef University at 1 site in Egypt.
Trial summary
The Proper position of a laryngeal mask airway (LMA) requires confirmation to ensure the adequacy of laryngeal seal and pulmonary ventilation. This confirmation may help in prevention of the peri-operative airway complication and ventilation events associated with LMA placement Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- the Position of Laryngeal Mask Airway
- What is being tested?
- the fiberoptic laryngoscope (KARL STORZ 11301BN1, Germany) for confirmation of LMA position
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteEgypt
- Study dates
- Oct 2019to Mar 2020
- Phase
- Phase 1
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients aged from 18- 60 years of either sex, ASA physical status I - II, weighting 50-100 kg, who will scheduled for elective surgery under general anesthesia.
Who cannot join
- - Patients whom LMA is contraindicated as patients who are at an increased risk of gastric aspiration as (obstetrics, hiatal hernia or esophageal reflux ), patients with high airway resistance e.g. (bronchospasm or pulmonary edema), patients with low pulmonary compliance e.g. (obesity), cases of an inability to open the mouth or an infection or pathologic abnormality within the oral cavity or pharynx and nonsupine position of operation .
- Patients with a known or predicted difficult airway as patients with class III and IV Modified Mallampati Score or with score > 5 wilson's risk score.
- Patients with cardiovascular disease (congestive heart failure, coronary artery disease), history of renal or hepatic insufficiency, and endocrinal Diseases will be excluded from the study.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Beni-suef University Hospital
Banī Suwayf, Beni Suweif Governorate
mohammed abd moselhy, MD, 0201145504361, mohamed-abdelkader@med.bsu.edu.eg
About this study
Official title: Comparison Between Blind And Ultrasound Guided Laryngeal Mask Airway Insertion In Adult Patients Undergoing Elective Surgery: A Randomized Control Study
The Proper position of a laryngeal mask airway (LMA) requires confirmation to ensure the adequacy of laryngeal seal and pulmonary ventilation. This confirmation may help in prevention of the peri-operative airway complication and ventilation events associated with LMA placement
Read the detailed description
It is common practice to inflate the cuff of LMA with the maximum recommended volume (size 3, 20 ml; size 4, 30 ml; size 5, 40 ml), as illustrated in several studies , but it may become more rigid which may cause displacement of the LMA and decreases the airway sealing of LMA, more pressure on pharyngeal mucosa which might cause severe mucosal ischemia leading to post- operative sore throat, dysphagia or hoarseness.
Ultrasonography can reliably confirm correct placement of supraglottic devices like laryngeal mask airway (LMA) and rules out causes of inadequate ventilation , also it was found to be a sensitive in detecting rotational malposition of LMA in children.
the replacement of air with saline in LMA cuffs enable detection of cuffs in the airway allowing visualization of the surrounding structures and tissues as the ultrasound beam can be transmitted through the fluid-filled cuffs without being reflected from air mucosal interface.
the adequacy of LMA position will be confirmed by a fiberoptic laryngoscope (FOL)
- Conditions
- the Position of Laryngeal Mask Airway
- Being tested
- the fiberoptic laryngoscope (KARL STORZ 11301BN1, Germany) for confirmation of LMA position
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
the fiberoptic laryngoscope (KARL STORZ 11301BN1, Germany) for confirmation of LMA positionProcedure or surgery
-The position of LMA will be assessed by another anesthetist (blinded assessor) using the fiberoptic laryngoscope (KARL STORZ 11301BN1, Germany) per the grading licensed by Aoyama et al.
| Study group | Role | What they receive |
|---|---|---|
| 1st group (group B) | Active comparator | The LMA LarySeal Multiple will be inserted using the blind technique which involves holding the LMA like a pen guided into the pharynx with the index finger of the operator at the junction of the tube and the bowl, with the operator at the head of the patient and the LMA facing caudally.
The position of LMA will be assessed by another anesthetist (blinded assessor) using the fiberoptic laryngoscope (KARL STORZ 11301BN1, Germany) per the grading devised by Aoyama et al. Receives: Procedure: the fiberoptic laryngoscope (KARL STORZ 11301BN1, Germany) for confirmation of LMA position |
| 2nd group:(group U) | Active comparator | The LMA LarySeal Multiple will be inserted under the guide of B-mode US on the anterior neck . Transverse scans , Sagittal view and Parasagittal view.
-The position of LMA will be assessed by another anesthetist (blinded assessor) using the fiberoptic laryngoscope (KARL STORZ 11301BN1, Germany) per the grading devised by Aoyama et al. Receives: Procedure: the fiberoptic laryngoscope (KARL STORZ 11301BN1, Germany) for confirmation of LMA position |
What is being measured
The primary outcome is the main question the study is designed to answer.
the Score of the fibreoptic view of the larynx
the aim of this study is to compare between the blind technique and US guided technique of laryngeal mask airway insertion regarding the position as confirmed by the fiberoptic laryngoscope.
Measured: from the clinical judgement of correct position (as ventilation without substantial leak at an airway pressure ≤20 cm H2O, observation of EtCO2 trace )up to 120 second
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2019
- Study startOct 2019 (estimated)
- Primary completionMar 2020 (estimated)
- Study completionMar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for the Position of Laryngeal Mask AirwayStudies of the same condition, open and under way.
- More trials run by Beni-Suef UniversityThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 102 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beni-Suef University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, mohammed abd elrehman moselhy, Beni-Suef University
- Investigators
- mohammed abd moselhy, MD, Principal investigator, lecturer in anesthesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04090944
- Sponsor's protocol ID
- Beni-suef Hospital
- Status last verified
- Sep 2019
- First submitted
- 13 Sep 2019
- Last updated
- 16 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Blind And Ultrasound Guided Laryngeal Mask Airway Insertion In Adult Patients Undergoing Elective Surgery: A Randomized Control Study
- ClinicalTrials.gov ID
- NCT04090944
- Acronym / sponsor ID
- Beni-suef Hospital
- Conditions
- the Position of Laryngeal Mask Airway
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- Beni-Suef UniversityUniversity, hospital or other
- Study start
- Oct 2019 (estimated)
- Primary completion
- Mar 2020 (estimated)
- Study completion
- Mar 2020 (estimated)
- First posted
- 16 Sep 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.
The Proper position of a laryngeal mask airway (LMA) requires confirmation to ensure the adequacy of laryngeal seal and pulmonary ventilation. This confirmation may help in prevention of the peri-operative airway complication and ventilation events associated with LMA placement
Detailed description
It is common practice to inflate the cuff of LMA with the maximum recommended volume (size 3, 20 ml; size 4, 30 ml; size 5, 40 ml), as illustrated in several studies , but it may become more rigid which may cause displacement of the LMA and decreases the airway sealing of LMA, more pressure on pharyngeal mucosa which might cause severe mucosal ischemia leading to post- operative sore throat, dysphagia or hoarseness.
Ultrasonography can reliably confirm correct placement of supraglottic devices like laryngeal mask airway (LMA) and rules out causes of inadequate ventilation , also it was found to be a sensitive in detecting rotational malposition of LMA in children.
the replacement of air with saline in LMA cuffs enable detection of cuffs in the airway allowing visualization of the surrounding structures and tissues as the ultrasound beam can be transmitted through the fluid-filled cuffs without being reflected from air mucosal interface.
the adequacy of LMA position will be confirmed by a fiberoptic laryngoscope (FOL)
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1st group (group B) | Active comparator | Procedure: the fiberoptic laryngoscope (KARL STORZ 11301BN1, Germany) for confirmation of LMA positionThe LMA LarySeal Multiple will be inserted using the blind technique which involves holding the LMA like a pen guided into the pharynx with the index finger of the operator at the junction of the tube and the bowl, with the operator at the head of the patient and the LMA facing caudally. The position of LMA will be assessed by another anesthetist (blinded assessor) using the fiberoptic laryngoscope (KARL STORZ 11301BN1, Germany) per the grading devised by Aoyama et al. |
| 2nd group:(group U) | Active comparator | Procedure: the fiberoptic laryngoscope (KARL STORZ 11301BN1, Germany) for confirmation of LMA positionThe LMA LarySeal Multiple will be inserted under the guide of B-mode US on the anterior neck . Transverse scans , Sagittal view and Parasagittal view. -The position of LMA will be assessed by another anesthetist (blinded assessor) using the fiberoptic laryngoscope (KARL STORZ 11301BN1, Germany) per the grading devised by Aoyama et al. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patients aged from 18- 60 years of either sex, ASA physical status I - II, weighting 50-100 kg, who will scheduled for elective surgery under general anesthesia.
Key exclusion criteria (3 listed)
- - Patients whom LMA is contraindicated as patients who are at an increased risk of gastric aspiration as (obstetrics, hiatal hernia or esophageal reflux ), patients with high airway resistance e.g. (bronchospasm or pulmonary edema), patients with low pulmonary compliance e.g. (obesity), cases of an inability to open the mouth or an infection or pathologic abnormality within the oral cavity or pharynx and nonsupine position of operation .
- Patients with a known or predicted difficult airway as patients with class III and IV Modified Mallampati Score or with score > 5 wilson's risk score.
- Patients with cardiovascular disease (congestive heart failure, coronary artery disease), history of renal or hepatic insufficiency, and endocrinal Diseases will be excluded from the study.
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 |
|---|---|---|
| the fiberoptic laryngoscope (KARL STORZ 11301BN1, Germany) for confirmation of LMA position-The position of LMA will be assessed by another anesthetist (blinded assessor) using the fiberoptic laryngoscope (KARL STORZ 11301BN1, Germany) per the grading licensed by Aoyama et al. | Procedure or surgery | 1st group (group B), 2nd group:(group U) |
Primary outcome
the Score of the fibreoptic view of the larynx
Time frame: from the clinical judgement of correct position (as ventilation without substantial leak at an airway pressure ≤20 cm H2O, observation of EtCO2 trace )up to 120 second
the aim of this study is to compare between the blind technique and US guided technique of laryngeal mask airway insertion regarding the position as confirmed by the fiberoptic laryngoscope.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2019.
- Individual participant dataSharing planned: No
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The Insertion of I-gel and Classic LMA in Different Head Positions in Elderly Patients
Airway Management Assessment, Supraglottic Airways
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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.
mohammed abd moselhy, MD principal investigator
lecturer in anesthesia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing the fiberoptic laryngoscope (KARL STORZ 11301BN1, Germany) for confirmation of LMA position in people with the Position of Laryngeal Mask Airway, run by Beni-Suef University at 1 site in Egypt.
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: status not confirmed, as of the sponsor's last update on 16 Sep 2019. 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 Egypt. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 mohammed abd moselhy, MD (0201145504361, mohamed_abdelkader@med.bsu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the Score of the fibreoptic view of the larynx (time frame: from the clinical judgement of correct position (as ventilation without substantial leak at an airway pressure ≤20 cm H2O, observation of EtCO2 trace )up to 120 second). 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 16 Sep 2019.