Effective I -Gel Mask Airway Placement TechniqueNCT03542032
Comparison of I-Gel Laryngeal Mask Airway Placement Methods in Elective Surgery
A study testing i-gel placement maneuvers in people with Effective I -Gel Mask Airway Placement Technique, run by Ankara Diskapi Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
To compare the jaw thrust maneuver with the conventional technical methods to place the I-Gel laryngeal mask Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Effective I -Gel Mask Airway Placement Technique
- What is being tested?
- i-gel placement maneuvers
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2018to 30 Jun 2019
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients between the ages of 18 and 75 years
- American Society of Anesthesiologists I, II or III
Who cannot join
- Those with anatomical disorders related to the upper airway
- lung disease
- gastric regurgitation
- Those who have had lung infection in the last 3 weeks
- Supraglottic airway vehicle not settled
- Those who are hired for any reason
Show all 9Show fewer
- EtCO2> 45
- American Society of Anesthesiologists 4 or 5
- -
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Diskapi Yildirim Beyazit Training Research Hospital
Ankara
About this study
Official title: Comparison of I -Gel Mask Airway Placement Methods in Elective Surgery: Jaw Thrust Maneuver vs Conventional Technique
To compare the jaw thrust maneuver with the conventional technical methods to place the I-Gel laryngeal mask
Read the detailed description
Patients who underwent elective surgery under general anesthesia and who were between the ages of 18 and 75 and who had ASA score I-II-III would be included in the study. Patients' mallampati scores, thyromental distances, mouth openings will be recorded.
Patients will be divided into two groups according to supraglottic airway insertion method.
Both groups will record the insertion time of i-gel, number of trials, operative time, placement complications.
Recorded complications (blood, laryngospasm, etc.) during insertion and removal of supraglottic airway devices will be assessed.
Patients' postoperative sore throat will be questioned and recorded.
- Being tested
- i-gel placement maneuvers
- Keywords
- i-gel, jaw-thrust
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
i-gel placement maneuversOther
the i-gel was inserted with triple airway maneuver (mouth opening, head extension and jaw thrust) In the classic maneuver , the index finger used as a guide, pushes the back of i-gel towards the hard palate, inserting it into the pharynx till a resistance is felt and the i-gel is then fixed it its place.
| Study group | Role | What they receive |
|---|---|---|
| jaw-thrust | Other | the i-gel was inserted with triple airway maneuver (mouth opening, head extension and jaw thrust) This groups will record the insertion time of i-gel, number of trials, operative time, placement complications.
Recorded complications (blood, laryngospasm, etc.) during insertion and removal of supraglottic airway devices will be assessed.
Patients' postoperative sore throat will be questioned and recorded. Receives: Other: i-gel placement maneuvers |
| classic group | No intervention | In the classic group, the index finger used as a guide, pushes the back of i-gel towards the hard palate, inserting it into the pharynx till a resistance is felt and the i-gel is then fixed it its place. This groups will record the insertion time of i-gel, number of trials, operative time, placement complications. Recorded complications (blood, laryngospasm, etc.) during insertion and removal of supraglottic airway devices will be assessed. Patients' postoperative sore throat will be questioned and recorded. |
What is being measured
The primary outcome is the main question the study is designed to answer.
insertion time
Time for successful i-gel insertion
Measured: 2 minutes
successful insertion number
successful insertion number
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 posted31 May 2018
- Study start1 Jun 2018
- Primary completion30 Mar 2019
- Study completion30 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Effective I -Gel Mask Airway Placement TechniqueStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara Diskapi Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ilkay baran akkuş, Diskapi Teaching and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03542032
- Sponsor's protocol ID
- I-Gel
- Status last verified
- May 2018
- First submitted
- 18 May 2018
- Last updated
- 5 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of I -Gel Mask Airway Placement Methods in Elective Surgery: Jaw Thrust Maneuver vs Conventional Technique
- ClinicalTrials.gov ID
- NCT03542032
- Acronym / sponsor ID
- I-Gel
- Keywords
- i-gel, jaw-thrust
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Ankara Diskapi Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 30 Mar 2019 (actual)
- Study completion
- 30 Jun 2019 (actual)
- First posted
- 31 May 2018 (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.
To compare the jaw thrust maneuver with the conventional technical methods to place the I-Gel laryngeal mask
Detailed description
Patients who underwent elective surgery under general anesthesia and who were between the ages of 18 and 75 and who had ASA score I-II-III would be included in the study. Patients' mallampati scores, thyromental distances, mouth openings will be recorded.
Patients will be divided into two groups according to supraglottic airway insertion method.
Both groups will record the insertion time of i-gel, number of trials, operative time, placement complications.
Recorded complications (blood, laryngospasm, etc.) during insertion and removal of supraglottic airway devices will be assessed.
Patients' postoperative sore throat will be questioned and recorded.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| jaw-thrust | Other | Other: i-gel placement maneuversthe i-gel was inserted with triple airway maneuver (mouth opening, head extension and jaw thrust) This groups will record the insertion time of i-gel, number of trials, operative time, placement complications. Recorded complications (blood, laryngospasm, etc.) during insertion and removal of supraglottic airway devices will be assessed. Patients' postoperative sore throat will be questioned and recorded. |
| classic group | No intervention | –In the classic group, the index finger used as a guide, pushes the back of i-gel towards the hard palate, inserting it into the pharynx till a resistance is felt and the i-gel is then fixed it its place. This groups will record the insertion time of i-gel, number of trials, operative time, placement complications. Recorded complications (blood, laryngospasm, etc.) during insertion and removal of supraglottic airway devices will be assessed. Patients' postoperative sore throat will be questioned and recorded. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients between the ages of 18 and 75 years
- American Society of Anesthesiologists I, II or III
Key exclusion criteria (9 listed)
- Those with anatomical disorders related to the upper airway
- lung disease
- gastric regurgitation
- Those who have had lung infection in the last 3 weeks
- Supraglottic airway vehicle not settled
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 placement maneuversthe i-gel was inserted with triple airway maneuver (mouth opening, head extension and jaw thrust) In the classic maneuver , the index finger used as a guide, pushes the back of i-gel towards the hard palate, inserting it into the pharynx till a resistance is felt and the i-gel is then fixed it its place. | Other | jaw-thrust |
Primary outcome
insertion time
Time frame: 2 minutes
Time for successful i-gel insertion
successful insertion number
Time frame: 2 minutes
successful insertion number
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 5 Jul 2019.
- Individual participant dataSharing planned: No
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 i-gel placement maneuvers in people with Effective I -Gel Mask Airway Placement Technique, run by Ankara Diskapi Training and Research Hospital at 1 site in Turkey (Türkiye).
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 9 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 5 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). 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?
insertion time (time frame: 2 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?
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 5 Jul 2019.