Laryngeal Mask AirwayNCT05832944
Hyomental Distance Measured Ultrasonography Versus Weight-based Criteria for Laryngeal Mask Size Selection in Children
A study testing ultrasound guided hyomental distance in people with Laryngeal Mask Airway, run by Tanta University at 1 site in Egypt.
Trial summary
In pediatric surgery and emergencies, LMA represents a useful airway management device for routine and difficult airway management. Inserting an improper LMA size may result in malposition, displacement within the hypopharynx, and failed ventilation that needs repositioning. Read more about this study
- Who is it for?
- Ages 5 to 14 years
- Conditions the study is for
- Laryngeal Mask Airway
- What is being tested?
- ultrasound guided hyomental distance
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- Jun 2023to Jan 2024
- 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 5 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Parents' acceptance
- Age: between 5-14 years
- Physical Status: American Society of Anesthesiologists (ASA) I \& II)
Who cannot join
- Developmental Delay (mental and physical growth retardation).
- Hypersensitivity to any type of used drugs.
- Patient with a difficult airway ( according to thyromental height and the Mallampati test)
- Patients with a history of neck surgery
- Airway malformation.
- Upper respiratory tract infection.
- Surgeries that will take up to more than forty-five minutes.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
kafrelsheikh university, Faculty of Medicine
Cairo, 00000
Sherif k Hafez, MD, 00201004397462, dr_shama2000@yahoo.com
About this study
Official title: Hyomental Distance Measured Ultrasonography Versus Weight-based Criteria for Laryngeal Mask Size Selection in Children. A Prospective, Randomised Controlled Study
- In pediatric surgery and emergencies, LMA represents a useful airway management device for routine and difficult airway management.
- Inserting an improper LMA size may result in malposition, displacement within the hypopharynx, and failed ventilation that needs repositioning.
- Selection of the size of LMA represents a major challenge for anesthesiologists, especially in children.
- The ultrasonographic measured hyomental distance showed a correlation with the length of the pharyngeal cavity.
- Optimization of the size of the inserted LMA can be confirmed either clinically, ultrasonographic or through the fiberoptic laryngoscope.
- The ultrasonographic measured hyomental distance confirmed the optimization of LMA with results comparable to that of the clinical methods and better than those of the fiberoptic laryngoscope.
Read the detailed description
- The laryngeal mask airway (LMA) is classified as one of the supraglottic devices that have been extensively adopted as an adjunctive or alternative technique to tracheal intubation or mask ventilation for airway management in short-time surgery. Moreover, it is characterized by ease of placement and removal, less injury to the respiratory tract, better tolerability by patients, improved hemodynamic stability, less coughing, less sore throat, avoidance of laryngoscopy, and hands-free airway. However, it is not suitable to overcome functional airway problems and mechanical airway obstruction.
- Although the weight-based method was considered the traditional method for the selection of the optimal LMA size, a clinical practice viewed that this method is not always applicable as there is no linear correlation between the upper airway anatomy and body weight with the presence of usual individual anatomical variation.
- Fortunately, ultrasonography gave high-resolution images of the anatomic structures of the upper airway comparable to computed tomography and magnetic resonance imaging, Ultrasound measurements were applied for the hyomental distance and the hyomental distance ratio. Some studies revealed variable sensitivity and specificity.
- This prospective randomized controlled study will aim to assess the efficacy and safety of ultrasonographic measured hyomental distance in the optimization of the laryngeal mask(LMA)size selection and placement in pediatric patients Operational Design
- Pre-anaesthetic management:
- Informed written parental consent will be taken from all participants.
- Medical history and complete clinical examination.
- Routine laboratory investigation including :
- CBC
- CRP
- INR, PT \& PTT
- Patients will fast for at least 8 hours before surgery.
- Routine Monitoring, including heart rate (HR), oxygen saturation (SpO2) and noninvasive blood pressure (NIBP) in the pre-anaesthesia room (Base Line Data).
- A peripheral intravenous line (24-22G) will be inserted.
- A premedication of 0.01 mg/kg Atropine will be administrated IM 1 hour before surgery.
- Induction of general anaesthesia:
- Routine monitoring, including heart rate (HR), oxygen saturation (SpO2), noninvasive blood pressure (NIBP) and continuous electrocardiography (ECG) in the operation room.
- Intravenous induction of anaesthesia will be performed using Propofol 2 mg/kg, and fentanyl 1µg/kg.
- Mechanical Ventilation: 6-8 mL/kg Tidal Volume, 10-20 bpm Respiratory Rate, end-tidal CO2 35-40 mmHg and Volume Controlled ventilation with an inspiratory-expiratory ratio of 1:2 will be initiated.
- For all patients, maintenance of anaesthesia will be performed using Sevoflurane 1-2 %. The depth of anaesthesia will be monitored according to HR.
- Process:
- Before starting the current study, a pilot experiment has been done, measuring the upper airway parameters of 10 children who used LMA during operation by ultrasound, investigators found that when the hyomental distance was less than 2 cm, 80% of subjects were suited for class 2 LMA and if 2-3 cm, suited for class 2.5 LMA. Additionally, size 3 LMA were fitted to the hyomental distance above 3 cm.
- After getting ethical committee approval, and clinical trial registration, 60 pediatric participants will be scheduled for surgery using a laryngeal mask and will be divided randomly into two groups (30 in each group)
- Conditions
- Laryngeal Mask Airway
- Being tested
- ultrasound guided hyomental distance
- Keywords
- hyomental distance, children
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasound guided hyomental distanceDevice
measuring the hyomental distance by ultrasound guidance
| Study group | Role | What they receive |
|---|---|---|
| Group HMD (30 patients) | Experimental | where the size of LMA will be according to measured hyomental distance by ultrasound as follows:
* If Less than 2 cm: LMA size 2 will be used.
* If 2-3 cm: LMA size 2.5 will be used.
* If more than 3 cm: LMA size 3 will be used. Receives: Device: ultrasound guided hyomental distance |
| Group CONTROL (30 patients) | No intervention | where size selection will be based on the weight guide |
What is being measured
The primary outcome is the main question the study is designed to answer.
correct size selection of LMA
- A five-point scale will be used to evaluate the ease of LMA insertion from 1 to 5, considering that 1 corresponds to (inserted without resistance) and 5 corresponds to (impossible to insert).
Measured: During LMA insertion (5 minutes duration)
Secondary outcomes (3)
Values of oropharyngeal leak pressure (OLP) after airway management
hearing of leakage sounds from LMA
Measured: During 30 minutes after LMA insertion
postoperative oral injury
blood adhering to the LMA surface
Measured: After removal of LMA for 5 minutes
many insertion attempts
defined as re-insertion after complete LMA removal from the oral cavity
Measured: During LMA insertion attempts for 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2023
- Study startJun 2023 (estimated)
- Primary completionNov 2023 (estimated)
- Study completionJan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laryngeal Mask AirwayStudies of the same condition, open and under way.
- More trials run by Tanta 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, AHMED ABDELAZIZ SHAMA, Tanta University
- Investigators
- AHMED A SHAMA, MD, Principal investigator, Assistant professor of anesthesia in Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05832944
- Sponsor's protocol ID
- MKSU 51-2-18
- Status last verified
- Apr 2023
- First submitted
- 16 Apr 2023
- Last updated
- 3 May 2023
- 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 3 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hyomental Distance Measured Ultrasonography Versus Weight-based Criteria for Laryngeal Mask Size Selection in Children. A Prospective, Randomised Controlled Study
- ClinicalTrials.gov ID
- NCT05832944
- Acronym / sponsor ID
- MKSU 51-2-18
- Conditions
- Laryngeal Mask Airway
- Keywords
- hyomental distance, children
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- Jun 2023 (estimated)
- Primary completion
- Nov 2023 (estimated)
- Study completion
- Jan 2024 (estimated)
- First posted
- 27 Apr 2023 (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.
- In pediatric surgery and emergencies, LMA represents a useful airway management device for routine and difficult airway management.
- Inserting an improper LMA size may result in malposition, displacement within the hypopharynx, and failed ventilation that needs repositioning.
- Selection of the size of LMA represents a major challenge for anesthesiologists, especially in children.
- The ultrasonographic measured hyomental distance showed a correlation with the length of the pharyngeal cavity.
- Optimization of the size of the inserted LMA can be confirmed either clinically, ultrasonographic or through the fiberoptic laryngoscope.
- The ultrasonographic measured hyomental distance confirmed the optimization of LMA with results comparable to that of the clinical methods and better than those of the fiberoptic laryngoscope.
Detailed description
- The laryngeal mask airway (LMA) is classified as one of the supraglottic devices that have been extensively adopted as an adjunctive or alternative technique to tracheal intubation or mask ventilation for airway management in short-time surgery. Moreover, it is characterized by ease of placement and removal, less injury to the respiratory tract, better tolerability by patients, improved hemodynamic stability, less coughing, less sore throat, avoidance of laryngoscopy, and hands-free airway. However, it is not suitable to overcome functional airway problems and mechanical airway obstruction.
- Although the weight-based method was considered the traditional method for the selection of the optimal LMA size, a clinical practice viewed that this method is not always applicable as there is no linear correlation between the upper airway anatomy and body weight with the presence of usual individual anatomical variation.
- Fortunately, ultrasonography gave high-resolution images of the anatomic structures of the upper airway comparable to computed tomography and magnetic resonance imaging, Ultrasound measurements were applied for the hyomental distance and the hyomental distance ratio. Some studies revealed variable sensitivity and specificity.
- This prospective randomized controlled study will aim to assess the efficacy and safety of ultrasonographic measured hyomental distance in the optimization of the laryngeal mask(LMA)size selection and placement in pediatric patients Operational Design
- Pre-anaesthetic management:
- Informed written parental consent will be taken from all participants.
- Medical history and complete clinical examination.
- Routine laboratory investigation including :
- CBC
- CRP
- INR, PT \& PTT
- Patients will fast for at least 8 hours before surgery.
- Routine Monitoring, including heart rate (HR), oxygen saturation (SpO2) and noninvasive blood pressure (NIBP) in the pre-anaesthesia room (Base Line Data).
- A peripheral intravenous line (24-22G) will be inserted.
- A premedication of 0.01 mg/kg Atropine will be administrated IM 1 hour before surgery.
- Induction of general anaesthesia:
- Routine monitoring, including heart rate (HR), oxygen saturation (SpO2), noninvasive blood pressure (NIBP) and continuous electrocardiography (ECG) in the operation room.
- Intravenous induction of anaesthesia will be performed using Propofol 2 mg/kg, and fentanyl 1µg/kg.
- Mechanical Ventilation: 6-8 mL/kg Tidal Volume, 10-20 bpm Respiratory Rate, end-tidal CO2 35-40 mmHg and Volume Controlled ventilation with an inspiratory-expiratory ratio of 1:2 will be initiated.
- For all patients, maintenance of anaesthesia will be performed using Sevoflurane 1-2 %. The depth of anaesthesia will be monitored according to HR.
- Process:
- Before starting the current study, a pilot experiment has been done, measuring the upper airway parameters of 10 children who used LMA during operation by ultrasound, investigators found that when the hyomental distance was less than 2 cm, 80% of subjects were suited for class 2 LMA and if 2-3 cm, suited for class 2.5 LMA. Additionally, size 3 LMA were fitted to the hyomental distance above 3 cm.
- After getting ethical committee approval, and clinical trial registration, 60 pediatric participants will be scheduled for surgery using a laryngeal mask and will be divided randomly into two groups (30 in each group)
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group HMD (30 patients) | Experimental | Device: ultrasound guided hyomental distancewhere the size of LMA will be according to measured hyomental distance by ultrasound as follows: * If Less than 2 cm: LMA size 2 will be used. * If 2-3 cm: LMA size 2.5 will be used. * If more than 3 cm: LMA size 3 will be used. |
| Group CONTROL (30 patients) | No intervention | –where size selection will be based on the weight guide |
Who may qualify
- Ages
- 5 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Parents' acceptance
- Age: between 5-14 years
- Physical Status: American Society of Anesthesiologists (ASA) I \& II)
Key exclusion criteria (7 listed)
- Developmental Delay (mental and physical growth retardation).
- Hypersensitivity to any type of used drugs.
- Patient with a difficult airway ( according to thyromental height and the Mallampati test)
- Patients with a history of neck surgery
- Airway malformation.
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 |
|---|---|---|
| ultrasound guided hyomental distancemeasuring the hyomental distance by ultrasound guidance | Device | Group HMD (30 patients) |
Primary outcome
correct size selection of LMA
Time frame: During LMA insertion (5 minutes duration)
* A five-point scale will be used to evaluate the ease of LMA insertion from 1 to 5, considering that 1 corresponds to (inserted without resistance) and 5 corresponds to (impossible to insert).
3 secondary outcomes
Values of oropharyngeal leak pressure (OLP) after airway management
Time frame: During 30 minutes after LMA insertion
postoperative oral injury
Time frame: After removal of LMA for 5 minutes
many insertion attempts
Time frame: During LMA insertion attempts for 5 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2023.
- Individual participant dataSharing planned: No
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Effect of Laryngeal Mask Airway vs Endotracheal Tube on Hypothermia in Laparoscopic Hernia Surgery
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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.
AHMED A SHAMA, MD principal investigator
Assistant professor of anesthesia in Tanta University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ultrasound guided hyomental distance in people with Laryngeal Mask Airway, run by Tanta 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 3 inclusion and 7 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 3 May 2023. 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.
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 AHMED A SHAMA, MD (0580925443, ahmed.shama@med.tanta.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
correct size selection of LMA (time frame: During LMA insertion (5 minutes duration)). 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 3 May 2023.