Training Group, SensitivityLMANCT05544838
Simulated Comparison of Standard Versus Rotational Laryngeal Mask Airway Insertion in Novice Anaesthesiologists.
A study testing LMA insertion with standard technique in people with Training Group, Sensitivity, run by Aga Khan University at 1 site in Pakistan.
Trial summary
The primary objective of study was to compare insertion ease by standard and rotational LMA insertion technique on basis of LMA insertion attempts and insertion time duration. The secondary objective of study was to analyse impact of prior information for airway device, insertion techniques, general or specific work… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Training Group, Sensitivity
- What is being tested?
- LMA insertion with standard technique
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 sitePakistan
- Study dates
- 2 Oct 2021to 2 Oct 2021
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- First year anaesthesia trainee
- Using adult mannequin
Who cannot join
- Paediatric mannequin
- Participant's refusal
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Simulation Based Comparison Of Standard Versus Rotational Laryngeal Mask Airway Insertion Technique In Novice Anesthesiologists. A Randomised Control Crossover Trial
The primary objective of study was to compare insertion ease by standard and rotational LMA insertion technique on basis of LMA insertion attempts and insertion time duration. The secondary objective of study was to analyse impact of prior information for airway device, insertion techniques, general or specific work experience in airway management with ease of both insertion techniques. And, tertiary objective of study was to analyse the trainee's preference insertion technique on basis of learning method and practical adaptability.
Hypothesis:
Read more
The rotational LMA insertion technique is easy to understand and practice than the standard LMA insertion technique at the beginning of airway management training among the novice anesthesiologists.
Hypothesis:
The rotational LMA insertion technique is easy to understand and practice than the standard LMA insertion technique at the beginning of airway management training among the novice anesthesiologists.
Read the detailed description
- LMA insertion attempts are the number of LMA insertion attempts with each study's insertion technique. The 10 insertion attempts will be performed with each insertion technique by trainees.
- LMA insertion time duration is the time taken to complete LMA insertion; from the holding of device till the confirmation of chest movement (artificial lungs inflation in manikin).
- The correlation of previous information for airway device, insertion techniques, general or specific work experience in airway management with the ease of both study's insertion techniques will be asked by participant's through the questionnaire at the start of study.
- The trainees will be asked at the end of study for preferred insertion method at novice level on the basis of learning method and practical conduct (user friendly)
- Conditions
- Training Group, Sensitivity
- Being tested
- LMA insertion with standard technique
- Keywords
- LMA, Technique, Standard, Rotational, Simulation
- Medical subject headings
- Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LMA insertion with standard techniqueDevice
Also called Rotational LMA insertion technique
Standard LMA insertion technique; LMA held like a pen and index finger placed at the junction of LMA tube and cuff. Index finger used to press LMA against hard palate and posterior pharyngeal wall until definite resistance felt at the base of hypopharynx. LMA then held with non- dominant hand and index finger removed.
Rotational LMA insertion; LMA inserted like guedel airway insertion: LMA proximally grasped close to anaesthesia circuit attachment. Insertion was conducted with LMA cuff facing towards nose, hard palate and then advanced into the base of hypopharynx until resistance was felt. At this point, LMA rotated at 180 degree anti-clockwise and LMA tube black line positioned and confirmed on the nasal side.
| Study group | Role | What they receive |
|---|---|---|
| LMA with standard insertion technique | No intervention | Standard LMA insertion technique; LMA held like a pen and index finger placed at the junction of LMA tube and cuff. Index finger used to press LMA against hard palate and posterior pharyngeal wall until definite resistance felt at the base of hypopharynx. LMA then held with non- dominant hand and index finger removed. |
| Rotational LMA insertion technique | Experimental | Rotational LMA insertion; LMA inserted like guedel airway insertion: LMA proximally grasped close to anaesthesia circuit attachment. Insertion was conducted with LMA cuff facing towards nose, hard palate and then advanced into the base of hypopharynx until resistance was felt. At this point, LMA rotated at 180 degree anti-clockwise and LMA tube black line positioned and confirmed on the nasal side. Receives: Device: LMA insertion with standard technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
The ease of LMA insertion was measured on the basis of number of LMA insertion attempts.
Ease of LMA insertion in mannequin mouth was measured by performing the 10 times insertion of LMA with both study techniques in mannequin mouth by trainees.
Measured: 5 minute
The ease of LMA insertion was measured on the basis of final LMA insertion time taken duration.
The total time duration of final LMA insertion confirmation in mannequin mouth was recorded. The time duration counting was started from LMA holding in operator's hand to the confirmed successful insertion in mannequin mouth.
Measured: 5 minutes
Secondary outcomes (4)
The trainee's baseline knowledge was assessed for the type of supraglottic airway devices and LMA insertion techniques.
The questionnaire based trainee's asked for the prior information of the LMA and other supraglottic airway devices.
Measured: 1 minute
The trainee's baseline knowledge was assessed for the type LMA insertion techniques.
The trainee's baseline knowledge was assessed for the type LMA insertion techniques.
Measured: 1 minute
The trainee's baseline knowledge was assessed for the general or specific work experience in airway management using the LMA.
The questionnaire based trainee's asked for previous experience in using the LMA device.
Measured: 1 minute
The trainee's baseline knowledge was assessed for the studied Rotational LMA insertion technique.
The questionnaire based trainee's asked for the previous experience for rotational LMA insertion technique.
Measured: 2 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2022
- Study start2 Oct 2021
- Primary completion2 Oct 2021
- Study completion2 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Training Group, SensitivityStudies 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
- Crossover
- Model description
- Each novice resident will place ten times LMA insertion with each insertion technique in randomised cross over manner by dividing the residents in two groups (5 residents in each group), by draw method. The one group will place LMA with standard insertion technique and other group will place by rotational LMA insertion technique, then after, the groups will switch over with concerned insertion techniques
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aga Khan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dileep Kumar, Aga Khan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05544838
- Sponsor's protocol ID
- 2022-6256-22361
- Acronym
- LMA
- Status last verified
- Sep 2022
- First submitted
- 13 Sep 2022
- Last updated
- 16 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The plan is to publish the study and consent has been taken from participants.
Publications
Kumar D, Khan M, Ishaq M. Rotational vs. standard smooth laryngeal mask airway insertion in adults. J Coll Physicians Surg Pak. 2012 May;22(5):275-9.
PubMed 22538029Komasawa N, Berg BW. Simulation-based Airway Management Training for Anesthesiologists - A Brief Review of its Essential Role in Skills Training for Clinical Competency. J Educ Perioper Med. 2017 Oct 1;19(4):E612. eCollection 2017 Oct-Dec.
PubMed 29766036Kennedy CC, Cannon EK, Warner DO, Cook DA. Advanced airway management simulation training in medical education: a systematic review and meta-analysis. Crit Care Med. 2014 Jan;42(1):169-78. doi: 10.1097/CCM.0b013e31829a721f.
PubMed 24220691Lee DW, Kang MJ, Kim YH, Lee JH, Cho KW, Kim YW, Cho JH, Kim YS, Hong CK, Hwang SY. Performance of intubation with 4 different airway devices by unskilled rescuers: manikin study. Am J Emerg Med. 2015 May;33(5):691-6. doi: 10.1016/j.ajem.2015.03.006. Epub 2015 Mar 12.
PubMed 25800412Liti A, Giusti GD, Gili A, Giontella M, Dell'Omo S, Camerlingo V, Fronteddu A, Galazzi A, Bambi S. Insertion of four different types of supraglottic airway devices by emergency nurses. A mannequin-based simulation study. Acta Biomed. 2020 Nov 30;91(12-S):e2020016. doi: 10.23750/abm.v91i12-S.10832.
PubMed 33263351D K, C K. Simulation-Based Comparison of Standard Versus Rotational Laryngeal Mask Airway Insertion Techniques in Novice Anesthesiologists: A Randomized Controlled Crossover Trial. Anesthesiol Res Pract. 2025 Dec 31;2025:7850095. doi: 10.1155/anrp/7850095. eCollection 2025.
PubMed 41479467
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Simulation Based Comparison Of Standard Versus Rotational Laryngeal Mask Airway Insertion Technique In Novice Anesthesiologists. A Randomised Control Crossover Trial
- ClinicalTrials.gov ID
- NCT05544838
- Acronym / sponsor ID
- LMA / 2022-6256-22361
- Conditions
- Training Group, Sensitivity
- Keywords
- LMA, Technique, Standard, Rotational, Simulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Aga Khan UniversityUniversity, hospital or other
- Study start
- 2 Oct 2021 (actual)
- Primary completion
- 2 Oct 2021 (actual)
- Study completion
- 2 Oct 2021 (actual)
- First posted
- 16 Sep 2022 (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 primary objective of study was to compare insertion ease by standard and rotational LMA insertion technique on basis of LMA insertion attempts and insertion time duration. The secondary objective of study was to analyse impact of prior information for airway device, insertion techniques, general or specific work experience in airway management with ease of both insertion techniques. And, tertiary objective of study was to analyse the trainee's preference insertion technique on basis of learning method and practical adaptability.
Hypothesis:
The rotational LMA insertion technique is easy to understand and practice than the standard LMA insertion technique at the beginning of airway management training among the novice anesthesiologists.
Hypothesis:
The rotational LMA insertion technique is easy to understand and practice than the standard LMA insertion technique at the beginning of airway management training among the novice anesthesiologists.
Detailed description
- LMA insertion attempts are the number of LMA insertion attempts with each study's insertion technique. The 10 insertion attempts will be performed with each insertion technique by trainees.
- LMA insertion time duration is the time taken to complete LMA insertion; from the holding of device till the confirmation of chest movement (artificial lungs inflation in manikin).
- The correlation of previous information for airway device, insertion techniques, general or specific work experience in airway management with the ease of both study's insertion techniques will be asked by participant's through the questionnaire at the start of study.
- The trainees will be asked at the end of study for preferred insertion method at novice level on the basis of learning method and practical conduct (user friendly)
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Each novice resident will place ten times LMA insertion with each insertion technique in randomised cross over manner by dividing the residents in two groups (5 residents in each group), by draw method. The one group will place LMA with standard insertion technique and other group will place by rotational LMA insertion technique, then after, the groups will switch over with concerned insertion techniques
| Arm | Type | Receives |
|---|---|---|
| LMA with standard insertion technique | No intervention | –Standard LMA insertion technique; LMA held like a pen and index finger placed at the junction of LMA tube and cuff. Index finger used to press LMA against hard palate and posterior pharyngeal wall until definite resistance felt at the base of hypopharynx. LMA then held with non- dominant hand and index finger removed. |
| Rotational LMA insertion technique | Experimental | Device: LMA insertion with standard techniqueRotational LMA insertion; LMA inserted like guedel airway insertion: LMA proximally grasped close to anaesthesia circuit attachment. Insertion was conducted with LMA cuff facing towards nose, hard palate and then advanced into the base of hypopharynx until resistance was felt. At this point, LMA rotated at 180 degree anti-clockwise and LMA tube black line positioned and confirmed on the nasal side. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- First year anaesthesia trainee
- Using adult mannequin
Key exclusion criteria (2 listed)
- Paediatric mannequin
- Participant's refusal
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 |
|---|---|---|
| LMA insertion with standard techniqueAlso: Rotational LMA insertion techniqueStandard LMA insertion technique; LMA held like a pen and index finger placed at the junction of LMA tube and cuff. Index finger used to press LMA against hard palate and posterior pharyngeal wall until definite resistance felt at the base of hypopharynx. LMA then held with non- dominant hand and index finger removed. Rotational LMA insertion; LMA inserted like guedel airway insertion: LMA proximally grasped close to anaesthesia circuit attachment. Insertion was conducted with LMA cuff facing towards nose, hard palate and then advanced into the base of hypopharynx until resistance was felt. At this point, LMA rotated at 180 degree anti-clockwise and LMA tube black line positioned and confirmed on the nasal side. | Device | Rotational LMA insertion technique |
Primary outcome
The ease of LMA insertion was measured on the basis of number of LMA insertion attempts.
Time frame: 5 minute
Ease of LMA insertion in mannequin mouth was measured by performing the 10 times insertion of LMA with both study techniques in mannequin mouth by trainees.
The ease of LMA insertion was measured on the basis of final LMA insertion time taken duration.
Time frame: 5 minutes
The total time duration of final LMA insertion confirmation in mannequin mouth was recorded. The time duration counting was started from LMA holding in operator's hand to the confirmed successful insertion in mannequin mouth.
4 secondary outcomes
The trainee's baseline knowledge was assessed for the type of supraglottic airway devices and LMA insertion techniques.
Time frame: 1 minute
The trainee's baseline knowledge was assessed for the type LMA insertion techniques.
Time frame: 1 minute
The trainee's baseline knowledge was assessed for the general or specific work experience in airway management using the LMA.
Time frame: 1 minute
The trainee's baseline knowledge was assessed for the studied Rotational LMA insertion technique.
Time frame: 2 minutes
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 16 Sep 2022.
- Background: PubMed 22538029Kumar D, Khan M, Ishaq M. Rotational vs. standard smooth laryngeal mask airway insertion in adults. J Coll Physicians Surg Pak. 2012 May;22(5):275-9.
- Background: PubMed 29766036Komasawa N, Berg BW. Simulation-based Airway Management Training for Anesthesiologists - A Brief Review of its Essential Role in Skills Training for Clinical Competency. J Educ Perioper Med. 2017 Oct 1;19(4):E612. eCollection 2017 Oct-Dec.
- Background: PubMed 24220691Kennedy CC, Cannon EK, Warner DO, Cook DA. Advanced airway management simulation training in medical education: a systematic review and meta-analysis. Crit Care Med. 2014 Jan;42(1):169-78. doi: 10.1097/CCM.0b013e31829a721f.
- Background: PubMed 25800412Lee DW, Kang MJ, Kim YH, Lee JH, Cho KW, Kim YW, Cho JH, Kim YS, Hong CK, Hwang SY. Performance of intubation with 4 different airway devices by unskilled rescuers: manikin study. Am J Emerg Med. 2015 May;33(5):691-6. doi: 10.1016/j.ajem.2015.03.006. Epub 2015 Mar 12.
- Results publication: PubMed 33263351Liti A, Giusti GD, Gili A, Giontella M, Dell'Omo S, Camerlingo V, Fronteddu A, Galazzi A, Bambi S. Insertion of four different types of supraglottic airway devices by emergency nurses. A mannequin-based simulation study. Acta Biomed. 2020 Nov 30;91(12-S):e2020016. doi: 10.23750/abm.v91i12-S.10832.
- Derived from this study: PubMed 41479467D K, C K. Simulation-Based Comparison of Standard Versus Rotational Laryngeal Mask Airway Insertion Techniques in Novice Anesthesiologists: A Randomized Controlled Crossover Trial. Anesthesiol Res Pract. 2025 Dec 31;2025:7850095. doi: 10.1155/anrp/7850095. eCollection 2025.
- Individual participant dataSharing planned: Yes. The plan is to publish the study and consent has been taken from participants.
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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?
A study testing LMA insertion with standard technique in people with Training Group, Sensitivity, 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 2 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 16 Sep 2022. 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?
The ease of LMA insertion was measured on the basis of number of LMA insertion attempts. (time frame: 5 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 NCT05544838, which also lists 6 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 16 Sep 2022.