Training Group, SensitivityI-gelNCT05545163
Comparison of Simulated Standard Versus Modified Jaw Thrust I-gel Insertion Technique in Novice Anesthesiologists
A study testing I-gel with standard insertion technique in people with Training Group, Sensitivity and Igel, run by Aga Khan University at 1 site in Pakistan.
Trial summary
The primary objective of study was to compare insertion ease by modified I-gel jaw thrust insertion technique and standard I-gel insertion technique on the basis of I-gel insertion attempts and I-gel insertion time duration. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Training Group, Sensitivity, Igel
- What is being tested?
- I-gel with standard insertion technique
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 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 residents
- Using adult mannequin
Who cannot join
- Pediatric mannequin
- Participant's refusal
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Simulated Standard Versus Modified Jaw Thrust I-gel Insertion Technique in Novice Anesthesiologists: A Randomised Control Crossover Trial
The primary objective of study was to compare insertion ease by modified I-gel jaw thrust insertion technique and standard I-gel insertion technique on the basis of I-gel insertion attempts and I-gel insertion time duration. The secondary objective of study was to analyse the impact of prior information for airway device, insertion techniques, general or specific work experience in airway management with the ease of both study's insertion techniques. And, tertiary objective of study was to analyse the trainee's preference insertion technique at the basis of learning method and practical adaptability.
Hypothesis:
The modified I-gel jaw thrust insertion technique is easy to understand and practice than the standard I-gel insertion technique at the beginning of airway management training among the novice anesthesiologists.
Read the detailed description
- I-gel insertion attempts are the number of I-gel insertion attempts with each study's insertion technique. The 10 insertion attempts allowed to performed with each insertion technique by trainees.
- I-gel insertion time duration was the time taken to complete I-gel insertion; from the holding of device till the confirmation of chest movement (artificial lung 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 were assessed by asking from participant's questionnaire based at the start of study.
- The trainees were 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, Igel
- Being tested
- I-gel with standard insertion technique
- Keywords
- I-gel, Technique, Standard, Modified, Simulation
- Medical subject headings
- Hypersensitivity, Ige Responsiveness, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
I-gel with standard insertion techniqueDevice
Also called Modified jaw thrust I-gel insertion technique
Standard I-gel insertion technique (grasping I-gel from integral bite block site and cuff facing towards chin and pressing down the manikin chin. I-gel introduced in patient's mouth in a direction towards hard palate. Then I-gel slided downwards and backwards along hard palate with a continuous but gentle push until a definitive resistance is felt)
Modified jaw thrust technique (grasping I-gel from integral bite block site and cuff facing towards chin and pressing down manikin chin. I-gel introduced in patient's mouth in a direction towards hard palate with gently advancing into oropharynx. Then after, I-gel left in oral cavity and both hands used to thrust jaw by lifting angle of mandible with little fingers and other fingers to stabilise jaw. And, at this point, both hand's thumbs used to apply balance force from I-gel stem head towards final placement position by looking at integral bite block mark at incisor teeth level)
| Study group | Role | What they receive |
|---|---|---|
| I-gel with standard insertion technique | No intervention | in this arm, trainees performed the standard I-gel insertion technique |
| Modified jaw thrust I-gel insertion technique | Experimental | in this arm, trainees performed modified jaw thrust insertion technique Receives: Device: I-gel with standard insertion technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
The ease of I-gel insertion was measured on the basis of number of I-gel insertion attempts.
Ease of I-gel insertion in mannequin mouth was measured by performing the 10 times insertion of I-gel with both study techniques in mannequin mouth by trainees.
Measured: 5 minutes
The ease of I-gel insertion was measured on the basis of final I-gel insertion time taken duration.
The total time duration of final I-gel insertion confirmation in mannequin mouth was recorded. The time duration counting was started from I-gel 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 I-gel insertion techniques.
The questionnaire based trainee's asked for the prior information of the I-gel and other supraglottic airway device.
Measured: 1 minute
The trainee's baseline knowledge was assessed for the type I-gel insertion techniques.
The questionnaire based trainee's asked for the prior information for the type of I-gel insertion techniques.
Measured: 1 minute
The trainee's baseline knowledge was assessed for the general or specific work experience in airway management using the I-gel.
The questionnaire based trainee's asked for previous experience in using the I-gel device.
Measured: 1 minute
The trainee's baseline knowledge was assessed for the studied modified jaw thrust I-gel insertion technique.
The questionnaire based trainee's asked for the previous experience for modified jaw thrust I-gel 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 posted19 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 (7)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 I-gel insertion with each insertion technique in randomized cross over manner by dividing the residents in two groups (5 residents in each group), by draw method. The one group will place I-gel with standard insertion technique and other group will place by modified jaw thrust I-gel insertion technique, then after, the groups will switch over with concerned insertion techniques
- Masking
- None (open label)
- Enrolment
- 14 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
- Investigators
- dileep kumar, MD, Principal investigator, Aga Khan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05545163
- Sponsor's protocol ID
- 2021-6257-21893
- Acronym
- I-gel
- Status last verified
- Sep 2022
- First submitted
- 13 Sep 2022
- Last updated
- 19 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
Boet S, Borges BC, Naik VN, Siu LW, Riem N, Chandra D, Bould MD, Joo HS. Complex procedural skills are retained for a minimum of 1 yr after a single high-fidelity simulation training session. Br J Anaesth. 2011 Oct;107(4):533-9. doi: 10.1093/bja/aer160. Epub 2011 Jun 9.
PubMed 21659406Kennedy 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 24220691Sun Y, Pan C, Li T, Gan TJ. Airway management education: simulation based training versus non-simulation based training-A systematic review and meta-analyses. BMC Anesthesiol. 2017 Feb 1;17(1):17. doi: 10.1186/s12871-017-0313-7.
PubMed 28143389Lee 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 25800412Jackson KM, Cook TM. Evaluation of four airway training manikins as patient simulators for the insertion of eight types of supraglottic airway devices. Anaesthesia. 2007 Apr;62(4):388-93. doi: 10.1111/j.1365-2044.2007.04983.x.
PubMed 17381577Kumar D, Hayat M, Khan A. i-gel insertion with modified jaw thrust technique. Indian J Anaesth. 2015 Feb;59(2):132-3. doi: 10.4103/0019-5049.151383. No abstract available.
PubMed 25788752Bhardwaj M, Singhal SK, Rashmi, Dahiya A. A prospective randomised trial to compare three insertion techniques for i-gel placement: Standard, reverse, and rotation. Indian J Anaesth. 2020 Jul;64(7):618-623. doi: 10.4103/ija.IJA_937_19. Epub 2020 Jul 1.
PubMed 32792739
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Simulated Standard Versus Modified Jaw Thrust I-gel Insertion Technique in Novice Anesthesiologists: A Randomised Control Crossover Trial
- ClinicalTrials.gov ID
- NCT05545163
- Acronym / sponsor ID
- I-gel / 2021-6257-21893
- Conditions
- Training Group, Sensitivity, Igel
- Keywords
- I-gel, Technique, Standard, Modified, Simulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 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
- 19 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 modified I-gel jaw thrust insertion technique and standard I-gel insertion technique on the basis of I-gel insertion attempts and I-gel insertion time duration. The secondary objective of study was to analyse the impact of prior information for airway device, insertion techniques, general or specific work experience in airway management with the ease of both study's insertion techniques. And, tertiary objective of study was to analyse the trainee's preference insertion technique at the basis of learning method and practical adaptability.
Hypothesis:
The modified I-gel jaw thrust insertion technique is easy to understand and practice than the standard I-gel insertion technique at the beginning of airway management training among the novice anesthesiologists.
Detailed description
- I-gel insertion attempts are the number of I-gel insertion attempts with each study's insertion technique. The 10 insertion attempts allowed to performed with each insertion technique by trainees.
- I-gel insertion time duration was the time taken to complete I-gel insertion; from the holding of device till the confirmation of chest movement (artificial lung 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 were assessed by asking from participant's questionnaire based at the start of study.
- The trainees were 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 I-gel insertion with each insertion technique in randomized cross over manner by dividing the residents in two groups (5 residents in each group), by draw method. The one group will place I-gel with standard insertion technique and other group will place by modified jaw thrust I-gel insertion technique, then after, the groups will switch over with concerned insertion techniques
| Arm | Type | Receives |
|---|---|---|
| I-gel with standard insertion technique | No intervention | –in this arm, trainees performed the standard I-gel insertion technique |
| Modified jaw thrust I-gel insertion technique | Experimental | Device: I-gel with standard insertion techniquein this arm, trainees performed modified jaw thrust insertion technique |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- First year anaesthesia residents
- Using adult mannequin
Key exclusion criteria (2 listed)
- Pediatric 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 |
|---|---|---|
| I-gel with standard insertion techniqueAlso: Modified jaw thrust I-gel insertion techniqueStandard I-gel insertion technique (grasping I-gel from integral bite block site and cuff facing towards chin and pressing down the manikin chin. I-gel introduced in patient's mouth in a direction towards hard palate. Then I-gel slided downwards and backwards along hard palate with a continuous but gentle push until a definitive resistance is felt) Modified jaw thrust technique (grasping I-gel from integral bite block site and cuff facing towards chin and pressing down manikin chin. I-gel introduced in patient's mouth in a direction towards hard palate with gently advancing into oropharynx. Then after, I-gel left in oral cavity and both hands used to thrust jaw by lifting angle of mandible with little fingers and other fingers to stabilise jaw. And, at this point, both hand's thumbs used to apply balance force from I-gel stem head towards final placement position by looking at integral bite block mark at incisor teeth level) | Device | Modified jaw thrust I-gel insertion technique |
Primary outcome
The ease of I-gel insertion was measured on the basis of number of I-gel insertion attempts.
Time frame: 5 minutes
Ease of I-gel insertion in mannequin mouth was measured by performing the 10 times insertion of I-gel with both study techniques in mannequin mouth by trainees.
The ease of I-gel insertion was measured on the basis of final I-gel insertion time taken duration.
Time frame: 5 minutes
The total time duration of final I-gel insertion confirmation in mannequin mouth was recorded. The time duration counting was started from I-gel 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 I-gel insertion techniques.
Time frame: 1 minute
The trainee's baseline knowledge was assessed for the type I-gel 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 I-gel.
Time frame: 1 minute
The trainee's baseline knowledge was assessed for the studied modified jaw thrust I-gel 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 19 Sep 2022.
- Background: PubMed 21659406Boet S, Borges BC, Naik VN, Siu LW, Riem N, Chandra D, Bould MD, Joo HS. Complex procedural skills are retained for a minimum of 1 yr after a single high-fidelity simulation training session. Br J Anaesth. 2011 Oct;107(4):533-9. doi: 10.1093/bja/aer160. Epub 2011 Jun 9.
- 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 28143389Sun Y, Pan C, Li T, Gan TJ. Airway management education: simulation based training versus non-simulation based training-A systematic review and meta-analyses. BMC Anesthesiol. 2017 Feb 1;17(1):17. doi: 10.1186/s12871-017-0313-7.
- 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.
- Background: PubMed 17381577Jackson KM, Cook TM. Evaluation of four airway training manikins as patient simulators for the insertion of eight types of supraglottic airway devices. Anaesthesia. 2007 Apr;62(4):388-93. doi: 10.1111/j.1365-2044.2007.04983.x.
- Background: PubMed 25788752Kumar D, Hayat M, Khan A. i-gel insertion with modified jaw thrust technique. Indian J Anaesth. 2015 Feb;59(2):132-3. doi: 10.4103/0019-5049.151383. No abstract available.
- Background: PubMed 32792739Bhardwaj M, Singhal SK, Rashmi, Dahiya A. A prospective randomised trial to compare three insertion techniques for i-gel placement: Standard, reverse, and rotation. Indian J Anaesth. 2020 Jul;64(7):618-623. doi: 10.4103/ija.IJA_937_19. Epub 2020 Jul 1.
- 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.
dileep kumar, MD principal investigator
Aga Khan 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 I-gel with standard insertion technique in people with Training Group, Sensitivity and Igel, 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 19 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 I-gel insertion was measured on the basis of number of I-gel insertion attempts. (time frame: 5 minutes). 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 NCT05545163, which also lists 7 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 19 Sep 2022.