Laryngeal MasksNCT03931122
Comparison of Weight-based Versus External Ear-size Based Technique for Selection of Laryngeal Mask Airway in Pediatric Surgical Patients.
A study testing Ear Size Based Method (Ambu® AuraOnce™ Laryngeal Mask Airway) in people with Laryngeal Masks and Minors, run by Aga Khan University at 1 site in Pakistan.
Trial summary
Laryngeal Mask Airway (LMA) is widely used in pediatric surgical patients. The manufacturer recommends the size of LMA to be used in children should be based on actual body weight but this method has several limitations. Read more about this study
- Who is it for?
- Ages 6 months to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Laryngeal Masks, Minors, Child
- What is being tested?
- Ear Size Based Method (Ambu® AuraOnce™ Laryngeal Mask Airway)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 136 participants
- Where
- 1 sitePakistan
- Study dates
- 11 Dec 2019to 15 Jun 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 6 months to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- All children aged between 6 months to 18 years of age of either sex
- American Society of Anesthesiologist (ASA) Classification I-II
- Elective surgical procedures in whom an LMA will be indicated
- Procedure lasting up to 2hrs
Who cannot join
- Any external ear morphological abnormality
- Previous external ear surgeries
- Patient/Parent refusal
- Children with oropharyngeal lesion
- Any patient conditions (Gastroesophageal Re-flux Disease [GERD], hiatal hernia, incomplete NPO, bowel obstruction etc.) or procedures requiring rapid sequence induction and intubation
- History of Upper respiratory tract infection (URTI) within the last 2 weeks
Trial locations and contacts
1 site in 1 country.
About this study
Laryngeal Mask Airway (LMA) is widely used in pediatric surgical patients. The manufacturer recommends the size of LMA to be used in children should be based on actual body weight but this method has several limitations. To overcome these concerns, various alternatives have been tried by different researchers, one of them is external ear size for LMA size selection. Investigators therefore would like to know whether the external ear size based method can be used for LMA size selection in pediatric surgical patients in Pakistan.
Read the detailed description
OBJECTIVE:
to determine whether external ear-size is non-inferior to weight for LMA size selection in pediatric surgical patients.
INTRODUCTION:
The Laryngeal Mask Airway (LMA) is widely used in pediatric population. The manufacturer recommends the size of LMA to be used in children should be based on actual body weight. However, this method has several limitations, the range of weight for a particular size is very wide, it may not be appropriate for overweight or underweight children as it is based on actual body weight rather than ideal body weight, in emergency situations where weight of the patient is unknown the correlation between weight and size of LMA is impossible, and finally weight based recommendation may not be suitable as development of the child's oropharyngeal cavity is related to height and age rather than weight. All these factors may lead to inappropriate size selection, which may result in larger sized LMA causing trauma/injury to the airway and smaller ones causing obstruction or insufficient ventilation. To overcome these concerns various alternatives to weight based technique have been tried by different researchers in both adult and pediatric patients, one of them is external ear size. Literature revealed differences in external ear size dimensions in different ethnic population and the investigator's literature search failed to reveal any local data/study in Pakistani pediatric patients where external ear size was compared or used for size selection of the LMA. The investigators therefore would like to know whether the external ear size based method can be used for LMA size selection in pediatric surgical patients in Pakistan.
HYPOTHESIS:
External ear-size based technique is not inferior to weight based technique for LMA selection in pediatric population.
- Conditions
- Laryngeal Masks, Minors, Child, Pediatrics
- Being tested
- Ear Size Based Method (Ambu® AuraOnce™ Laryngeal Mask Airway)
- Keywords
- Ear Size
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ear Size Based Method (Ambu® AuraOnce™ Laryngeal Mask Airway)Device
The Laryngeal Mask Airway (LMA) is one of the devices used to maintain airway during general anesthesia. Its appropriate size is selected according to patients body weight as recommended by the manufacturer.
However its appropriate size can also be selected via several other methods and one of them is patients external ear size. In this study the investigators will compare external ear size based method for LMA selection with the standard weight based method for LMA size selection.
Vertical Ear length: will be measured from the most dependent portion of the lobule to the furthest portion of the auricle.
Horizontal Ear length (width): from the tragus to the furthest part of the helix horizontally.
Dimension(cm2): Vertical length (L) × Horizontal length (width-W)
LMA Size LMA Cuff Length (cm) corresponding to vertical ear length.
LMA Cuff Width (cm) corresponding to horizontal ear width.
| Study group | Role | What they receive |
|---|---|---|
| Group A - Weight Based Method | No intervention | Body Weight Based method: This is the conventional method for LMA size selection. The patient will be weighed and LMA size corresponding to their weight will be used as follows. (LMA Size - 1 for up to 5 kg of body weight) (LMA Size - 1.5 for 5 to 10 kg of body weight) (LMA Size - 2 for 10 to 20 kg of body weight) (LMA Size - 2.5 for 20 to 30 kg of body weight) (LMA Size - 3 for 30 to 50 kg of body weight) |
| Group B - Ear Size Based Method | Experimental | Ear Size Based method: External ear size will be measured by using a paper ruler and will be recorded in cm as follows:
Vertical length: will be measured from the most dependent portion of the lobule to the furthest portion of the auricle.
Horizontal length (width): from the tragus to the furthest part of the helix horizontally.
Dimension(cm2): Vertical length (L) × Horizontal length (width-W )
Based on these ear measurements, nearest smaller LMA size will be selected. Receives: Device: Ear Size Based Method (Ambu® AuraOnce™ Laryngeal Mask Airway) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proper Placement
Proper LMA placement will be assessed by chest expansion on positive pressure ventilation, absence of audible leak and a square wave capnograph waveform.
Measured: 1 minute
Adequacy of Ventilation
Adequacy of ventilation: will be judged by an oxygen saturation of greater than or equal to 95% at a Fractional Inspired Oxygen concentration (FiO2) less than 0.5 and an end-tidal carbon dioxide (ETCO2) of 35-45 mmHg at a tidal volume of 6- 8 ml/kg Actual Body Weight (ABW) at peak airway pressure less than the oropharyngeal leak pressure (OLP), and by adjusting the respiratory rate (RR).
Measured: 1 minute
Secondary outcomes (3)
Oropharyngeal Leak Pressure (OLP)
Oropharyngeal Leak Pressure (OLP): will be determined at LMA intra-cuff pressure of 60 cmH2O by closing the Adjustable Pressure Limiting (APL) valve of the circle system at a fixed gas flow of 3 Liters per minute and by noting the circuit pressure at which an equilibrium will be reached and then releasing it completely.
Measured: 30 seconds
Leak fraction (LF)
Leak fraction (LF): will be determined by comparing the difference between inspired and expired tidal volumes and dividing them by the inspired tidal volume at a tidal volume (TV) of 8 ml/kg actual body weight (ABW) with an I:E ratio of 1:2 and respiratory rate (RR) of 20 breaths per minute.
Measured: 1 minute
Incidence of mucosal injury and laryngospasm
Incidence of mucosal injury in the two groups will be assessed by trauma or minor injury to the airway seen as blood on the device after removal.
Incidence of laryngospasm will also be noted.
Measured: 1 minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2019
- Study start11 Dec 2019
- Primary completion1 May 2024
- Study completion15 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (28)Papers the sponsor has linked to this study.
- Other trials for Laryngeal MasksStudies 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
- Model description
- All Laryngeal Mask Airways (LMA) devices being used in the study will be Ambu® AuraOnce™ (Ambu® A/S Baltorpbakken 13 DK-2750 Ballerup, Denmark) LMA's. LMA Size Selection: will be done for each patient according to group allocation: Group A - Weight based method Group B - Ear Size Based method Randomization technique: Patients will be randomized according to computer-generated blocked randomization (https://www.sealedenvelope.com) with blocks size of 6, by independent statistician (Anaesthesia research cell). Allocation concealment will be ensured by enclosing assignments in sealed, opaque, sequentially numbered envelopes which will be opened by one of the investigator only upon arrival of the patient in the operation room.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 136 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aga Khan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammad Qamarul Hoda, Aga Khan University
- Investigators
- Muhammad Qamarul Hoda, FCAI, Principal investigator, The Aga Khan University Hospital, Karachi, Pakistan.Muhammad Asghar Ali, FCPS, Principal investigator, The Aga Khan University Hospital, Karachi, Pakistan.Hameed Ullah, FCPS, Principal investigator, The Aga Khan University Hospital, Karachi, Pakistan.Samie Asghar Dogar, FCPS, Principal investigator, The Aga Khan University Hospital, Karachi, Pakistan.Muhammad Saad Yousuf, FCPS, Principal investigator, The Aga Khan University Hospital, Karachi, Pakistan.Bushra Salim, FCPS, Principal investigator, The Aga Khan University Hospital, Karachi, Pakistan.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03931122
- Sponsor's protocol ID
- 2019-0246-3299
- Status last verified
- Jun 2024
- First submitted
- 20 Apr 2019
- Last updated
- 26 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The investigators will not publish any identifiable data, it will remain confidential. However the investigators will present this study in local and international meetings and also publish it in local or international journal.
Publications
Lopez-Gil M, Brimacombe J, Alvarez M. Safety and efficacy of the laryngeal mask airway. A prospective survey of 1400 children. Anaesthesia. 1996 Oct;51(10):969-72. doi: 10.1111/j.1365-2044.1996.tb14968.x.
PubMed 8984875Kim MS, Lee JS, Nam SB, Kang HJ, Kim JE. Randomized Comparison of Actual and Ideal Body Weight for Size Selection of the Laryngeal Mask Airway Classic in Overweight Patients. J Korean Med Sci. 2015 Aug;30(8):1197-202. doi: 10.3346/jkms.2015.30.8.1197. Epub 2015 Jul 15.
PubMed 26240500Kim HJ, Park MJ, Kim JT, Kim CS, Kim SD, Kim HS. Appropriate laryngeal mask airway size for overweight and underweight children. Anaesthesia. 2010 Jan;65(1):50-3. doi: 10.1111/j.1365-2044.2009.06160.x. Epub 2009 Nov 17.
PubMed 19922510Ho AM, Karmakar MK, Dion PW. Choosing the correct laryngeal mask airway sizes and cuff inflation volumes in pediatric patients. J Emerg Med. 2008 Oct;35(3):299-300. doi: 10.1016/j.jemermed.2007.10.073. Epub 2008 May 7.
PubMed 18462912Rommel N, Bellon E, Hermans R, Smet M, De Meyer AM, Feenstra L, Dejaeger E, Veereman-Wauters G. Development of the orohypopharyngeal cavity in normal infants and young children. Cleft Palate Craniofac J. 2003 Nov;40(6):606-11. doi: 10.1597/1545-1569_2003_040_0606_dotoci_2.0.co_2.
PubMed 14577816Tang MY, Tang IP, Wang CY. Optimal Size AMBU(R) Laryngeal Mask Airway Among Asian Adult Population. Med J Malaysia. 2014 Aug;69(4):151-5.
PubMed 25500841Devitt JH, Wenstone R, Noel AG, O'Donnell MP. The laryngeal mask airway and positive-pressure ventilation. Anesthesiology. 1994 Mar;80(3):550-5. doi: 10.1097/00000542-199403000-00011.
PubMed 8141451Huang YH, Cherng CH. Optimal size selection of the classic laryngeal mask airway by tongue width-based method in male adults. J Chin Med Assoc. 2014 Aug;77(8):422-5. doi: 10.1016/j.jcma.2014.05.009. Epub 2014 Jul 16.
PubMed 25043385Weng M, Ding M, Xu Y, Yang X, Li L, Zhong J, Miao C. An Evaluation of Thyromental Distance-based Method or Weight-based Method in Determining the Size of the Laryngeal Mask Airway Supreme: A Randomized Controlled Study. Medicine (Baltimore). 2016 Mar;95(9):e2902. doi: 10.1097/MD.0000000000002902.
PubMed 26945383Gallart L, Mases A, Martinez J, Montes A, Fernandez-Galinski S, Puig MM. Simple method to determine the size of the laryngeal mask airway in children. Eur J Anaesthesiol. 2003 Jul;20(7):570-4. doi: 10.1017/s0265021503000917.
PubMed 12884992Zahoor A, Ahmad N, Sereche G, Riad W. A novel method for laryngeal mask airway size selection in paediatric patients. Eur J Anaesthesiol. 2012 Aug;29(8):386-90. doi: 10.1097/EJA.0b013e32835562f4.
PubMed 22692042Haliloglu M, Bilgen S, Uzture N, Koner O. [Simple method for determining the size of the ProSeal laryngeal mask airway in children: a prospective observational study]. Rev Bras Anestesiol. 2017 Jan-Feb;67(1):15-20. doi: 10.1016/j.bjan.2016.09.007. Epub 2016 Sep 29. Portuguese.
PubMed 27692804Alexander KS, Stott DJ, Sivakumar B, Kang N. A morphometric study of the human ear. J Plast Reconstr Aesthet Surg. 2011 Jan;64(1):41-7. doi: 10.1016/j.bjps.2010.04.005. Epub 2010 May 5.
PubMed 20447883Suzanna AB, Liu CY, Rozaidi SW, Ooi JS. Comparison between LMA-Classic and AMBU AuraOnce laryngeal mask airway in patients undergoing elective general anaesthesia with positive pressure ventilation. Med J Malaysia. 2011 Oct;66(4):304-7.
PubMed 22299547Jagannathan N, Hajduk J, Sohn L, Huang A, Sawardekar A, Gebhardt ER, Johnson K, De Oliveira GS. A randomised comparison of the Ambu(R) AuraGain and the LMA(R) supreme in infants and children. Anaesthesia. 2016 Feb;71(2):205-12. doi: 10.1111/anae.13330. Epub 2015 Dec 9.
PubMed 26648173
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Weight-based Versus External Ear-size Based Technique for Selection of Laryngeal Mask Airway in Pediatric Surgical Patients.
- ClinicalTrials.gov ID
- NCT03931122
- Acronym / sponsor ID
- 2019-0246-3299
- Conditions
- Laryngeal Masks, Minors, Child, Pediatrics
- Keywords
- Ear Size
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 136 participants (actual)
- Lead sponsor
- Aga Khan UniversityUniversity, hospital or other
- Study start
- 11 Dec 2019 (actual)
- Primary completion
- 1 May 2024 (actual)
- Study completion
- 15 Jun 2024 (actual)
- First posted
- 30 Apr 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.
Laryngeal Mask Airway (LMA) is widely used in pediatric surgical patients. The manufacturer recommends the size of LMA to be used in children should be based on actual body weight but this method has several limitations. To overcome these concerns, various alternatives have been tried by different researchers, one of them is external ear size for LMA size selection. Investigators therefore would like to know whether the external ear size based method can be used for LMA size selection in pediatric surgical patients in Pakistan.
Detailed description
OBJECTIVE:
to determine whether external ear-size is non-inferior to weight for LMA size selection in pediatric surgical patients.
INTRODUCTION:
The Laryngeal Mask Airway (LMA) is widely used in pediatric population. The manufacturer recommends the size of LMA to be used in children should be based on actual body weight. However, this method has several limitations, the range of weight for a particular size is very wide, it may not be appropriate for overweight or underweight children as it is based on actual body weight rather than ideal body weight, in emergency situations where weight of the patient is unknown the correlation between weight and size of LMA is impossible, and finally weight based recommendation may not be suitable as development of the child's oropharyngeal cavity is related to height and age rather than weight. All these factors may lead to inappropriate size selection, which may result in larger sized LMA causing trauma/injury to the airway and smaller ones causing obstruction or insufficient ventilation. To overcome these concerns various alternatives to weight based technique have been tried by different researchers in both adult and pediatric patients, one of them is external ear size. Literature revealed differences in external ear size dimensions in different ethnic population and the investigator's literature search failed to reveal any local data/study in Pakistani pediatric patients where external ear size was compared or used for size selection of the LMA. The investigators therefore would like to know whether the external ear size based method can be used for LMA size selection in pediatric surgical patients in Pakistan.
HYPOTHESIS:
External ear-size based technique is not inferior to weight based technique for LMA selection in pediatric population.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- All Laryngeal Mask Airways (LMA) devices being used in the study will be Ambu® AuraOnce™ (Ambu® A/S Baltorpbakken 13 DK-2750 Ballerup, Denmark) LMA's. LMA Size Selection: will be done for each patient according to group allocation: Group A - Weight based method Group B - Ear Size Based method Randomization technique: Patients will be randomized according to computer-generated blocked randomization (https://www.sealedenvelope.com) with blocks size of 6, by independent statistician (Anaesthesia research cell). Allocation concealment will be ensured by enclosing assignments in sealed, opaque, sequentially numbered envelopes which will be opened by one of the investigator only upon arrival of the patient in the operation room.
| Arm | Type | Receives |
|---|---|---|
| Group A - Weight Based Method | No intervention | –Body Weight Based method: This is the conventional method for LMA size selection. The patient will be weighed and LMA size corresponding to their weight will be used as follows. (LMA Size - 1 for up to 5 kg of body weight) (LMA Size - 1.5 for 5 to 10 kg of body weight) (LMA Size - 2 for 10 to 20 kg of body weight) (LMA Size - 2.5 for 20 to 30 kg of body weight) (LMA Size - 3 for 30 to 50 kg of body weight) |
| Group B - Ear Size Based Method | Experimental | Device: Ear Size Based Method (Ambu® AuraOnce™ Laryngeal Mask Airway)Ear Size Based method: External ear size will be measured by using a paper ruler and will be recorded in cm as follows: Vertical length: will be measured from the most dependent portion of the lobule to the furthest portion of the auricle. Horizontal length (width): from the tragus to the furthest part of the helix horizontally. Dimension(cm2): Vertical length (L) × Horizontal length (width-W ) Based on these ear measurements, nearest smaller LMA size will be selected. |
Who may qualify
- Ages
- 6 months to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- All children aged between 6 months to 18 years of age of either sex
- American Society of Anesthesiologist (ASA) Classification I-II
- Elective surgical procedures in whom an LMA will be indicated
- Procedure lasting up to 2hrs
Key exclusion criteria (6 listed)
- Any external ear morphological abnormality
- Previous external ear surgeries
- Patient/Parent refusal
- Children with oropharyngeal lesion
- Any patient conditions (Gastroesophageal Re-flux Disease [GERD], hiatal hernia, incomplete NPO, bowel obstruction etc.) or procedures requiring rapid sequence induction and intubation
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 |
|---|---|---|
| Ear Size Based Method (Ambu® AuraOnce™ Laryngeal Mask Airway)The Laryngeal Mask Airway (LMA) is one of the devices used to maintain airway during general anesthesia. Its appropriate size is selected according to patients body weight as recommended by the manufacturer. However its appropriate size can also be selected via several other methods and one of them is patients external ear size. In this study the investigators will compare external ear size based method for LMA selection with the standard weight based method for LMA size selection. Vertical Ear length: will be measured from the most dependent portion of the lobule to the furthest portion of the auricle. Horizontal Ear length (width): from the tragus to the furthest part of the helix horizontally. Dimension(cm2): Vertical length (L) × Horizontal length (width-W) LMA Size LMA Cuff Length (cm) corresponding to vertical ear length. LMA Cuff Width (cm) corresponding to horizontal ear width. | Device | Group B - Ear Size Based Method |
Primary outcome
Proper Placement
Time frame: 1 minute
Proper LMA placement will be assessed by chest expansion on positive pressure ventilation, absence of audible leak and a square wave capnograph waveform.
Adequacy of Ventilation
Time frame: 1 minute
Adequacy of ventilation: will be judged by an oxygen saturation of greater than or equal to 95% at a Fractional Inspired Oxygen concentration (FiO2) less than 0.5 and an end-tidal carbon dioxide (ETCO2) of 35-45 mmHg at a tidal volume of 6- 8 ml/kg Actual Body Weight (ABW) at peak airway pressure less than the oropharyngeal leak pressure (OLP), and by adjusting the respiratory rate (RR).
3 secondary outcomes
Oropharyngeal Leak Pressure (OLP)
Time frame: 30 seconds
Leak fraction (LF)
Time frame: 1 minute
Incidence of mucosal injury and laryngospasm
Time frame: 1 minute
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 26 Jun 2024.
- Background: PubMed 8984875Lopez-Gil M, Brimacombe J, Alvarez M. Safety and efficacy of the laryngeal mask airway. A prospective survey of 1400 children. Anaesthesia. 1996 Oct;51(10):969-72. doi: 10.1111/j.1365-2044.1996.tb14968.x.
- Background: PubMed 26240500Kim MS, Lee JS, Nam SB, Kang HJ, Kim JE. Randomized Comparison of Actual and Ideal Body Weight for Size Selection of the Laryngeal Mask Airway Classic in Overweight Patients. J Korean Med Sci. 2015 Aug;30(8):1197-202. doi: 10.3346/jkms.2015.30.8.1197. Epub 2015 Jul 15.
- Background: PubMed 19922510Kim HJ, Park MJ, Kim JT, Kim CS, Kim SD, Kim HS. Appropriate laryngeal mask airway size for overweight and underweight children. Anaesthesia. 2010 Jan;65(1):50-3. doi: 10.1111/j.1365-2044.2009.06160.x. Epub 2009 Nov 17.
- Background: PubMed 18462912Ho AM, Karmakar MK, Dion PW. Choosing the correct laryngeal mask airway sizes and cuff inflation volumes in pediatric patients. J Emerg Med. 2008 Oct;35(3):299-300. doi: 10.1016/j.jemermed.2007.10.073. Epub 2008 May 7.
- Background: PubMed 14577816Rommel N, Bellon E, Hermans R, Smet M, De Meyer AM, Feenstra L, Dejaeger E, Veereman-Wauters G. Development of the orohypopharyngeal cavity in normal infants and young children. Cleft Palate Craniofac J. 2003 Nov;40(6):606-11. doi: 10.1597/1545-1569_2003_040_0606_dotoci_2.0.co_2.
- Background: PubMed 25500841Tang MY, Tang IP, Wang CY. Optimal Size AMBU(R) Laryngeal Mask Airway Among Asian Adult Population. Med J Malaysia. 2014 Aug;69(4):151-5.
- Background: PubMed 8141451Devitt JH, Wenstone R, Noel AG, O'Donnell MP. The laryngeal mask airway and positive-pressure ventilation. Anesthesiology. 1994 Mar;80(3):550-5. doi: 10.1097/00000542-199403000-00011.
- Background: PubMed 25043385Huang YH, Cherng CH. Optimal size selection of the classic laryngeal mask airway by tongue width-based method in male adults. J Chin Med Assoc. 2014 Aug;77(8):422-5. doi: 10.1016/j.jcma.2014.05.009. Epub 2014 Jul 16.
- Background: PubMed 26945383Weng M, Ding M, Xu Y, Yang X, Li L, Zhong J, Miao C. An Evaluation of Thyromental Distance-based Method or Weight-based Method in Determining the Size of the Laryngeal Mask Airway Supreme: A Randomized Controlled Study. Medicine (Baltimore). 2016 Mar;95(9):e2902. doi: 10.1097/MD.0000000000002902.
- Background: PubMed 12884992Gallart L, Mases A, Martinez J, Montes A, Fernandez-Galinski S, Puig MM. Simple method to determine the size of the laryngeal mask airway in children. Eur J Anaesthesiol. 2003 Jul;20(7):570-4. doi: 10.1017/s0265021503000917.
- Background: PubMed 22692042Zahoor A, Ahmad N, Sereche G, Riad W. A novel method for laryngeal mask airway size selection in paediatric patients. Eur J Anaesthesiol. 2012 Aug;29(8):386-90. doi: 10.1097/EJA.0b013e32835562f4.
- Background: PubMed 27692804Haliloglu M, Bilgen S, Uzture N, Koner O. [Simple method for determining the size of the ProSeal laryngeal mask airway in children: a prospective observational study]. Rev Bras Anestesiol. 2017 Jan-Feb;67(1):15-20. doi: 10.1016/j.bjan.2016.09.007. Epub 2016 Sep 29. Portuguese.
- Individual participant dataSharing planned: Yes. The investigators will not publish any identifiable data, it will remain confidential. However the investigators will present this study in local and international meetings and also publish it in local or international journal.
Related trials for Laryngeal Masks
Not yet recruitingPhase 4
Effect of Neuromuscular Blocking Agent Use on Video Laryngeal Mask Airway Insertion
Airway Management, Supraglottic Airway Device Insertion
RecruitingObservational study
Effect of Muscle Relaxants on Postoperative Sore Throat in Video Laryngeal Mask Airway(LMA) Use
Laryngeal Mask Airway
RecruitingObservational study
The Effect of Ultrasonographic Airway Measurements and Anatomical Differences on Laryngeal Mask Placement in Young and Older Adults
Airway Management, Laryngeal Mask Airway Insertion Skill
Not yet recruitingObservational study
Comparison of I-gel and SaCoVLM in Laparoscopic Cholecystectomy
Hemodynamic Monitoring, Laryngeal Mask Success Rate
Recruiting
Supraglottic Airway for Resuscitation in Preemies
Respiratory Failure, Premature Neonates
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.
Muhammad Qamarul Hoda, FCAI principal investigator
The Aga Khan University Hospital, Karachi, Pakistan.
Muhammad Asghar Ali, FCPS principal investigator
The Aga Khan University Hospital, Karachi, Pakistan.
Hameed Ullah, FCPS principal investigator
The Aga Khan University Hospital, Karachi, Pakistan.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ear Size Based Method (Ambu® AuraOnce™ Laryngeal Mask Airway) in people with Laryngeal Masks and Minors, run by Aga Khan University at 1 site in Pakistan.
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 4 inclusion and 6 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 26 Jun 2024. 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 Pakistan. 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?
Proper Placement (time frame: 1 minute). The study lists 2 primary outcomes in all. 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 NCT03931122, which also lists 28 linked publications.
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 26 Jun 2024; AzTrials last refreshed its copy on 29 Oct 2026.