Airway MorbidityNCT04109898
Comparison of Ease of I-gel Insertion With Two Different Techniques in Adults
A study testing Supraglottic airway device (I-gel) insertion in people with Airway Morbidity, run by Aga Khan University at 1 site in Pakistan.
Trial summary
Study will evaluate the I-gel airway device standard insertion technique versus interventional (modified jaw thurst) insertion technique in adult patients. The half of the patients will receive standard and other half will receive the modified jaw thrust insertion technique Read more about this study
- Who is it for?
- Ages 16 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Airway Morbidity
- What is being tested?
- Supraglottic airway device (I-gel) insertion
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114 participants
- Where
- 1 sitePakistan
- Study dates
- 7 Sep 2019to 19 Mar 2020
- 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 16 to 60 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- ASA I and II patients.
- Age 16 years to 60 years.
- Patient scheduled for elective surgical procedure.
Who cannot join
- Gastroesophageal reflux disorders
- Obesity BMI more than 30.
- Pregnancy
- Reactive airway disease/asthma
- Patients with mallampati score III \& IV
- Anticipated difficult airway
- Emergent surgery.
- Known allergic to isoflurane and propofol.
Trial locations and contacts
1 site in 1 country.
About this study
Study will evaluate the I-gel airway device standard insertion technique versus interventional (modified jaw thurst) insertion technique in adult patients. The half of the patients will receive standard and other half will receive the modified jaw thrust insertion technique
Read the detailed description
The I-gel is used to provide the oxygenation and ventilation in anaesthetised patients. The inventor suggested insertion technique is called standard technique.
Standard I-gel insertion technique: I-gel insertion will be performed by firmly grasping the lubricated I-gel along the integral bite block site. I-gel cuff outlet will face towards the patient's chin and before insertion chin will be gently pressed down. The I-gel soft tip will be introduced into patient's mouth in a direction towards the hard palate. Then I-gel will be slide downwards and backwards along the hard palate with a continuous but gentle push until a definitive resistance is felt.
Modified jaw thrust technique: I-gel insertion will be performed by firmly grasping the lubricated I-gel along the integral bite block. I-gel cuff outlet will face towards the patient's chin and before insertion chin will be gently pressed down. The I-gel soft tip will be introduced into patient's mouth in a direction towards the hard palate and it slides gently into the oropharynx. I-gel will be left in oral cavity and both hands will be used to thrust the jaw by lifting the angle of mandible with little fingers and other fingers to stabilize the jaw then both thumbs will used to apply the balance force towards the final I-gel placement position by looking at the integral bite block mark at incisor teeth level.
- Conditions
- Airway Morbidity
- Being tested
- Supraglottic airway device (I-gel) insertion
- Keywords
- airway management, I-gel, anaesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supraglottic airway device (I-gel) insertionDevice
Modified I-gel insertion technique believed to be easier and non traumatic in anaesthetised patients.
| Study group | Role | What they receive |
|---|---|---|
| standard I-gel insertion technique | No intervention | Investigator will apply the recommended (standard) I-gel insertion technique in patients |
| Modified I-gel insertion technique | Experimental | Investigator will apply the modified (interventional) I-gel insertion technique in patients Receives: Device: Supraglottic airway device (I-gel) insertion |
What is being measured
The primary outcome is the main question the study is designed to answer.
adverse airway events
All study patients will be monitored for I-gel insertion resistance, insertion time duration, insertion attempts.
Measured: 5 minutes
Secondary outcomes (1)
adverse airway events
All study patients will be monitored forI-gel insertion complications such as an laryngospasm, hypoxemia (Sp02<92%) and trauma to surrounding airway structures will be observe as blood stained I-gel at removal.
Measured: 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2019
- Study start7 Sep 2019
- Primary completion15 Mar 2020
- Study completion19 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Airway MorbidityStudies 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 114 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
- NCT04109898
- Sponsor's protocol ID
- 2019-1878-4900.
- Status last verified
- Feb 2021
- First submitted
- 27 Sep 2019
- Last updated
- 16 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Ease of I-gel Insertion With Two Different Techniques in Adults
- ClinicalTrials.gov ID
- NCT04109898
- Acronym / sponsor ID
- 2019-1878-4900.
- Conditions
- Airway Morbidity
- Keywords
- airway management, I-gel, anaesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- Aga Khan UniversityUniversity, hospital or other
- Study start
- 7 Sep 2019 (actual)
- Primary completion
- 15 Mar 2020 (actual)
- Study completion
- 19 Mar 2020 (actual)
- First posted
- 1 Oct 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.
Study will evaluate the I-gel airway device standard insertion technique versus interventional (modified jaw thurst) insertion technique in adult patients. The half of the patients will receive standard and other half will receive the modified jaw thrust insertion technique
Detailed description
The I-gel is used to provide the oxygenation and ventilation in anaesthetised patients. The inventor suggested insertion technique is called standard technique.
Standard I-gel insertion technique: I-gel insertion will be performed by firmly grasping the lubricated I-gel along the integral bite block site. I-gel cuff outlet will face towards the patient's chin and before insertion chin will be gently pressed down. The I-gel soft tip will be introduced into patient's mouth in a direction towards the hard palate. Then I-gel will be slide downwards and backwards along the hard palate with a continuous but gentle push until a definitive resistance is felt.
Modified jaw thrust technique: I-gel insertion will be performed by firmly grasping the lubricated I-gel along the integral bite block. I-gel cuff outlet will face towards the patient's chin and before insertion chin will be gently pressed down. The I-gel soft tip will be introduced into patient's mouth in a direction towards the hard palate and it slides gently into the oropharynx. I-gel will be left in oral cavity and both hands will be used to thrust the jaw by lifting the angle of mandible with little fingers and other fingers to stabilize the jaw then both thumbs will used to apply the balance force towards the final I-gel placement position by looking at the integral bite block mark at incisor teeth level.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| standard I-gel insertion technique | No intervention | –Investigator will apply the recommended (standard) I-gel insertion technique in patients |
| Modified I-gel insertion technique | Experimental | Device: Supraglottic airway device (I-gel) insertionInvestigator will apply the modified (interventional) I-gel insertion technique in patients |
Who may qualify
- Ages
- 16 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- ASA I and II patients.
- Age 16 years to 60 years.
- Patient scheduled for elective surgical procedure.
Key exclusion criteria (8 listed)
- Gastroesophageal reflux disorders
- Obesity BMI more than 30.
- Pregnancy
- Reactive airway disease/asthma
- Patients with mallampati score III \& IV
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 |
|---|---|---|
| Supraglottic airway device (I-gel) insertionModified I-gel insertion technique believed to be easier and non traumatic in anaesthetised patients. | Device | Modified I-gel insertion technique |
Primary outcome
adverse airway events
Time frame: 5 minutes
All study patients will be monitored for I-gel insertion resistance, insertion time duration, insertion attempts.
1 secondary outcome
adverse airway events
Time frame: 60 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 Feb 2021.
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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 Supraglottic airway device (I-gel) insertion in people with Airway Morbidity, 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 3 inclusion and 8 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 Feb 2021. 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?
adverse airway events (time frame: 5 minutes). 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 16 Feb 2021.