Ultrasound ImagingNCT04652466
Ultrasound Imaging to Validate I-gel Placement in pediatrıc Patients
An observational study of Ultrasound Imaging and Supraglottic Airway Device, run by Selcuk University at 1 site in Turkey (Türkiye).
Trial summary
For nearly half a century, supraglottic airway devices (SGA) have been used in pediatric patients, which are more practical than face masks, facilitate oxygenation and ventilation without the need for endotracheal intubation, and less invasive than endotracheal tubes. Read more about this study
- Who is it for?
- Ages 1 month to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Ultrasound Imaging, Supraglottic Airway Device, Fiberoptic Bronchoscopy
- What is being tested?
- farukcicekci2
- Type of treatment
- Medical device
- How many people
- 110 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Dec 2020to 15 Feb 2021
- Phase
- Observational
- 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 1 month to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: The pediatric patients who were scheduled to undergo surgery under general anesthesia placed I-Gel for airway were enrolled in the study.
Who may be able to join
- Undergoing elective pediatric surgery
- American Society of Anesthesiologists (ASA) status I-II
- Placed I-Gel for airway
Who cannot join
- Patients with head and neck anatomical malformation and airway congenital defects
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Selcuk University, School of Medicine
Konya, 42250
About this study
Official title: Comparison of Fiberoptic Bronchoscopy and Ultrasound Imaging to Validate I-gel Placement in Pediatric Patients
For nearly half a century, supraglottic airway devices (SGA) have been used in pediatric patients, which are more practical than face masks, facilitate oxygenation and ventilation without the need for endotracheal intubation, and less invasive than endotracheal tubes. I-Gel is a supraglottic airway management device introduced in 2007, made of a medical grade thermoplastic elastomer, designed to create a non-inflatable, anatomical seal in the pharyngeal, laryngeal and perilaryngeal structures that prevents compression trauma. Recently, the use of I-Gel has become popular in children undergoing surgery that does not require muscle relaxation. It is important to place an I-Gel in the most appropriate position in order to provide adequate ventilation and prevent complications such as mucosal injury, glottic ptosis, and gastric insufflation with potential aspiration. Successful placement is usually clinically assessed by a capnogram with endtidal carbon dioxide (ETCO2) value, visual examination and auscultation with appropriate chest elevation, absence of oropharyngeal leakage at 20 cm H2O peak inspiratory pressure. Although Fiberoptic Bronchoscope (FOB) is accepted as the preferred verification tool for direct visualization, some studies on I-Gel position using FOB reported that I-Gel placement should be repositioned in some children (12.8-49%). Ultrasonography (USG), which has recently entered the practice of upper airway examination, has become a valuable, non-invasive, simple and portable technology for evaluating airway management even in upper airway anatomy impaired by pathology or trauma. The aim of this study is to compare the use of USG with the FOB to evaluate I-Gel placement in pediatric patients. The primary endpoint is to compare the incidence of for I-Gel malposition between USG and FOB. Secondary endpoints are to find the correlation between I-Gel's USG and FOB-detected malposition and to determine the diagnostic performance of the USG.
Read the detailed description
The population of the study was created from the parents of pediatric patients who were scheduled for elective pediatric surgery under general anesthesia between December 2020 and February 2021 at Selcuk University Department of Anesthesiology and Reanimation. All patients were monitored with standard monitoring (ECG, non-invasive blood pressure, SpO2, ETCO2, Ppeak), after a minimum of 2 minutes of preoxygenation, mask ventilation was performed with 6-7% sevoflurane at the beginning of general anesthesia induction. Intravenous vein access was provided, and according to standard procedures; propofol 3.5 mg.kg 1, fentanyl 1 mg.kg 1 iv and remifentanil 0.1 mcg kg min 1 infusion was administered, but neuromuscular blocker was not used. The choice of the size of the I-Gel was selected according to the manufacturer's recommendations (size 1: 2-5 kg, size 1.5: 5 to 12 kg, size 2: 10 to 25 kg). Adequate anesthesia depth was confirmed by loss of eyelash reflex, symmetrical small pupils and absence of swallowing, and was guided gently along the hard palate by the 1st anesthesiologist until resistance was felt, with the I-Gel opening facing the applicator. If the patient did not tolerate the insertion of the I-Gel, an extra dose of fentanyl up to a maximum of 0.5 mcg / kg in total was administered. However, if the insertion attempt was still not tolerated, or if the capnography curve was not obtained and there was an audible leak, the technique was considered to be unsuccessful, and another SGA was then placed in the airway. If this change was not tolerated, endotracheal intubation was initiated by applying neuromuscular blocker and these were recorded.
USG examination of the neck was performed by the second anesthesiologist using an 8-18 MHz linear probe Esaote Imaging was done in three planes (Transverse plane between hyoid bone and thyroid bone, Transverse plane of the lateral suprasternal notch and Parasagittal plane of pharynx and larynx) the USG score was assigned to the deployment view using a modification of the criteria proposed.
The fiberoptic bronchoscope was passed through I-Gel until the glottis image was obtained.Optimal placement was defined as the end of the I-Gel behind the arytenoids, with a visible epiglottis, with or without folding to the airway, and the vocal cords are visible when the FOB is advanced under the epiglottis.
- Being tested
- farukcicekci2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
farukcicekci2Device
To compare the incidence of for I-Gel malposition between USG and FOB, and to find the correlation between I-Gel's USG and FOB-detected malposition
What is being measured
The primary outcome is the main question the study is designed to answer.
the incidence of for I-Gel malposition between USG and FOB
to compare the incidence of for I-Gel malposition between USG and FOB.
Measured: 1 months
Secondary outcomes (1)
the correlation between I-Gel's USG and FOB
to find the correlation between I-Gel's USG and FOB-detected malposition and to determine the diagnostic performance of the USG.
Measured: 1 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2020
- Study start15 Dec 2020 (estimated)
- Primary completion30 Jan 2021 (estimated)
- Study completion15 Feb 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ultrasound ImagingStudies of the same condition, open and under way.
- More trials run by Selcuk UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Selcuk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Faruk Cicekci, Selcuk University
- Investigators
- Faruk Cicekci, Principal investigator, Selcuk University, School of Medicine, Department of Anesthesiology and Intensive Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04652466
- Sponsor's protocol ID
- farukcicekci2
- Status last verified
- Nov 2020
- First submitted
- 26 Nov 2020
- Last updated
- 3 Dec 2020
- 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 3 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Fiberoptic Bronchoscopy and Ultrasound Imaging to Validate I-gel Placement in Pediatric Patients
- ClinicalTrials.gov ID
- NCT04652466
- Acronym / sponsor ID
- farukcicekci2
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Selcuk UniversityUniversity, hospital or other
- Study start
- 15 Dec 2020 (estimated)
- Primary completion
- 30 Jan 2021 (estimated)
- Study completion
- 15 Feb 2021 (estimated)
- First posted
- 3 Dec 2020 (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.
For nearly half a century, supraglottic airway devices (SGA) have been used in pediatric patients, which are more practical than face masks, facilitate oxygenation and ventilation without the need for endotracheal intubation, and less invasive than endotracheal tubes. I-Gel is a supraglottic airway management device introduced in 2007, made of a medical grade thermoplastic elastomer, designed to create a non-inflatable, anatomical seal in the pharyngeal, laryngeal and perilaryngeal structures that prevents compression trauma. Recently, the use of I-Gel has become popular in children undergoing surgery that does not require muscle relaxation. It is important to place an I-Gel in the most appropriate position in order to provide adequate ventilation and prevent complications such as mucosal injury, glottic ptosis, and gastric insufflation with potential aspiration. Successful placement is usually clinically assessed by a capnogram with endtidal carbon dioxide (ETCO2) value, visual examination and auscultation with appropriate chest elevation, absence of oropharyngeal leakage at 20 cm H2O peak inspiratory pressure. Although Fiberoptic Bronchoscope (FOB) is accepted as the preferred verification tool for direct visualization, some studies on I-Gel position using FOB reported that I-Gel placement should be repositioned in some children (12.8-49%). Ultrasonography (USG), which has recently entered the practice of upper airway examination, has become a valuable, non-invasive, simple and portable technology for evaluating airway management even in upper airway anatomy impaired by pathology or trauma. The aim of this study is to compare the use of USG with the FOB to evaluate I-Gel placement in pediatric patients. The primary endpoint is to compare the incidence of for I-Gel malposition between USG and FOB. Secondary endpoints are to find the correlation between I-Gel's USG and FOB-detected malposition and to determine the diagnostic performance of the USG.
Detailed description
The population of the study was created from the parents of pediatric patients who were scheduled for elective pediatric surgery under general anesthesia between December 2020 and February 2021 at Selcuk University Department of Anesthesiology and Reanimation. All patients were monitored with standard monitoring (ECG, non-invasive blood pressure, SpO2, ETCO2, Ppeak), after a minimum of 2 minutes of preoxygenation, mask ventilation was performed with 6-7% sevoflurane at the beginning of general anesthesia induction. Intravenous vein access was provided, and according to standard procedures; propofol 3.5 mg.kg 1, fentanyl 1 mg.kg 1 iv and remifentanil 0.1 mcg kg min 1 infusion was administered, but neuromuscular blocker was not used. The choice of the size of the I-Gel was selected according to the manufacturer's recommendations (size 1: 2-5 kg, size 1.5: 5 to 12 kg, size 2: 10 to 25 kg). Adequate anesthesia depth was confirmed by loss of eyelash reflex, symmetrical small pupils and absence of swallowing, and was guided gently along the hard palate by the 1st anesthesiologist until resistance was felt, with the I-Gel opening facing the applicator. If the patient did not tolerate the insertion of the I-Gel, an extra dose of fentanyl up to a maximum of 0.5 mcg / kg in total was administered. However, if the insertion attempt was still not tolerated, or if the capnography curve was not obtained and there was an audible leak, the technique was considered to be unsuccessful, and another SGA was then placed in the airway. If this change was not tolerated, endotracheal intubation was initiated by applying neuromuscular blocker and these were recorded.
USG examination of the neck was performed by the second anesthesiologist using an 8-18 MHz linear probe Esaote Imaging was done in three planes (Transverse plane between hyoid bone and thyroid bone, Transverse plane of the lateral suprasternal notch and Parasagittal plane of pharynx and larynx) the USG score was assigned to the deployment view using a modification of the criteria proposed.
The fiberoptic bronchoscope was passed through I-Gel until the glottis image was obtained.Optimal placement was defined as the end of the I-Gel behind the arytenoids, with a visible epiglottis, with or without folding to the airway, and the vocal cords are visible when the FOB is advanced under the epiglottis.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 month to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- The pediatric patients who were scheduled to undergo surgery under general anesthesia placed I-Gel for airway were enrolled in the study.
Key inclusion criteria (3 listed)
- Undergoing elective pediatric surgery
- American Society of Anesthesiologists (ASA) status I-II
- Placed I-Gel for airway
Key exclusion criteria (1 listed)
- Patients with head and neck anatomical malformation and airway congenital defects
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 |
|---|---|---|
| farukcicekci2To compare the incidence of for I-Gel malposition between USG and FOB, and to find the correlation between I-Gel's USG and FOB-detected malposition | Device | – |
Primary outcome
the incidence of for I-Gel malposition between USG and FOB
Time frame: 1 months
to compare the incidence of for I-Gel malposition between USG and FOB.
1 secondary outcome
the correlation between I-Gel's USG and FOB
Time frame: 1 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2020.
- Individual participant dataSharing planned: No
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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.
Faruk Cicekci principal investigator
Selcuk University, School of Medicine, Department of Anesthesiology and Intensive Care
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ultrasound Imaging and Supraglottic Airway Device, run by Selcuk University 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 3 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 3 Dec 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Faruk Cicekci (00905057649235, farukcicekci@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the incidence of for I-Gel malposition between USG and FOB (time frame: 1 months). 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 3 Dec 2020.