Mucosal DamageNCT04062747
The Effect Of I-Gel And Ambu Aura-I Use On Laryngofaryngeal Mucosa
A study testing I-gel and Ambu aura i in people with Mucosal Damage, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
Trial summary
Supraglottic airway devices (SGADs) are frequently preferred in surgical surgery for pediatric patients. i-gel LMA (laryngeal mask airway) and Ambu Aura-i LMA are the new generation supraglottic airway devices. Read more about this study
- Who is it for?
- Ages Up to 2 years
- Conditions the study is for
- Mucosal Damage
- What is being tested?
- I-gel and Ambu aura i
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 18 May 2019to 20 Sep 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 Up to 2 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- ASA I
- patients under the age of 1,
- body weight of less than 10 kg
- without anatomical pathology in the upper airway
- no general anesthesia within the last 2 weeks who underwent minor surgery
Who cannot join
- older than 1 year of age
- body weight of more than 10 kg
- symptoms of upper or lower respiratory tract infection
- more than one trial performed during the SADs placement
- known and expected to be difficult airway
- undergone surgery for more than 2 hours and patients
- underwent emergency surgery
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Bezmialem Vakıf University
Istanbul, Fatih, 34093
About this study
Official title: Comparison Of The Effect Of I-Gel And Ambu Aura-I Use On Laryngofaryngeal Mucosa Wıth Flexible Bronchoscopy in Infants
Supraglottic airway devices (SGADs) are frequently preferred in surgical surgery for pediatric patients. i-gel LMA (laryngeal mask airway) and Ambu Aura-i LMA are the new generation supraglottic airway devices. The aim of this study was to compare airway trauma and postoperative complications due to i-gel and Ambu Aura in infants. In the study patients were divided into two groups performed on minor surgery ASA I (American Society of Anesthesiologists score) and 40 infants. After standard anesthesia i-Gel was placed into a group and Ambu Aura-i was placed to the other. Flexible bronchoscopy was performed at the end of surgery. Mucosal damage and postoperative complications in laryngopharyngeal structures were compared.
Read the detailed description
This study was conducted as prospective, randomized and double-blind study. After confirmation the approval from the Interventional Ethics Committee of the Bezmialem Vakif University, dated…. Number…., the study was started. Forty ASA I patients under the age of 1, with a body weight of more than 10 kg, without anatomical pathology in the upper airway with no general anesthesia within the last 2 weeks who underwent minor surgery (circumcision, inguinal hernia, undescended testis, hypospadias, etc.) by the Pediatric Surgery Clinic at Bezmialem Vakif University Medical School Hospital were included in the study. Patients who are older than 1 year of age and have a body weight of more than 10 kg, who have symptoms of upper or lower respiratory tract infection, who have more than one trial performed during the SADs placement, who are known and expected to be difficult airway, who has undergone surgery for more than 2 hours and patients who underwent emergency surgery were not included in the study.
- Conditions
- Mucosal Damage
- Being tested
- I-gel, Ambu aura i
- Keywords
- Laryngeal Mask, I-gel, Ambu Aura i, Flexible bronchoscopy, Laryngopharyngeal damage, Infant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
I-gelDevice
Also called I-gel laryngeal mask airway
After standard anesthesia i-Gel was placed into the patient
Ambu aura iDevice
Also called Ambu aura i laryngeal mask airway
After standard anesthesia ambu aura was placed into the patient
| Study group | Role | What they receive |
|---|---|---|
| I-gel LMA | Active comparator | After standard anesthesia i-Gel was placed into the patient. Receives: Device: I-gel |
| Ambu Aura-i | Active comparator | After standard anesthesia Ambu Aura-i was placed into the patient. Receives: Device: Ambu aura i |
What is being measured
The primary outcome is the main question the study is designed to answer.
airway trauma
4 point scoring system 1- no hyperemia 2- mild hyperemia 3- severe hyperemia 4-mucosal damage and bleeding
Measured: up to 1 minute after extubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2019
- Study start18 May 2019
- Primary completion15 Sep 2019 (estimated)
- Study completion20 Sep 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mucosal DamageStudies of the same condition, open and under way.
- More trials run by Bezmialem Vakif 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Mucosal damage and postoperative complications in laryngopharyngeal structures were compared.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bezmialem Vakif University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04062747
- Sponsor's protocol ID
- 71306642-S001
- Status last verified
- Aug 2019
- First submitted
- 8 Aug 2019
- Last updated
- 20 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
- 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 20 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Of The Effect Of I-Gel And Ambu Aura-I Use On Laryngofaryngeal Mucosa Wıth Flexible Bronchoscopy in Infants
- ClinicalTrials.gov ID
- NCT04062747
- Acronym / sponsor ID
- 71306642-S001
- Conditions
- Mucosal Damage
- Keywords
- Laryngeal Mask, I-gel, Ambu Aura i, Flexible bronchoscopy, Laryngopharyngeal damage, Infant
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Bezmialem Vakif UniversityUniversity, hospital or other
- Study start
- 18 May 2019 (actual)
- Primary completion
- 15 Sep 2019 (estimated)
- Study completion
- 20 Sep 2019 (estimated)
- First posted
- 20 Aug 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.
Supraglottic airway devices (SGADs) are frequently preferred in surgical surgery for pediatric patients. i-gel LMA (laryngeal mask airway) and Ambu Aura-i LMA are the new generation supraglottic airway devices. The aim of this study was to compare airway trauma and postoperative complications due to i-gel and Ambu Aura in infants. In the study patients were divided into two groups performed on minor surgery ASA I (American Society of Anesthesiologists score) and 40 infants. After standard anesthesia i-Gel was placed into a group and Ambu Aura-i was placed to the other. Flexible bronchoscopy was performed at the end of surgery. Mucosal damage and postoperative complications in laryngopharyngeal structures were compared.
Detailed description
This study was conducted as prospective, randomized and double-blind study. After confirmation the approval from the Interventional Ethics Committee of the Bezmialem Vakif University, dated…. Number…., the study was started. Forty ASA I patients under the age of 1, with a body weight of more than 10 kg, without anatomical pathology in the upper airway with no general anesthesia within the last 2 weeks who underwent minor surgery (circumcision, inguinal hernia, undescended testis, hypospadias, etc.) by the Pediatric Surgery Clinic at Bezmialem Vakif University Medical School Hospital were included in the study. Patients who are older than 1 year of age and have a body weight of more than 10 kg, who have symptoms of upper or lower respiratory tract infection, who have more than one trial performed during the SADs placement, who are known and expected to be difficult airway, who has undergone surgery for more than 2 hours and patients who underwent emergency surgery were not included in the study.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- Mucosal damage and postoperative complications in laryngopharyngeal structures were compared.
| Arm | Type | Receives |
|---|---|---|
| I-gel LMA | Active comparator | Device: I-gelAfter standard anesthesia i-Gel was placed into the patient. |
| Ambu Aura-i | Active comparator | Device: Ambu aura iAfter standard anesthesia Ambu Aura-i was placed into the patient. |
Who may qualify
- Ages
- Up to 2 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- ASA I
- patients under the age of 1,
- body weight of less than 10 kg
- without anatomical pathology in the upper airway
- no general anesthesia within the last 2 weeks who underwent minor surgery
Key exclusion criteria (7 listed)
- older than 1 year of age
- body weight of more than 10 kg
- symptoms of upper or lower respiratory tract infection
- more than one trial performed during the SADs placement
- known and expected to be difficult airway
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-gelAlso: I-gel laryngeal mask airwayAfter standard anesthesia i-Gel was placed into the patient | Device | I-gel LMA |
| Ambu aura iAlso: Ambu aura i laryngeal mask airwayAfter standard anesthesia ambu aura was placed into the patient | Device | Ambu Aura-i |
Primary outcome
airway trauma
Time frame: up to 1 minute after extubation
4 point scoring system 1- no hyperemia 2- mild hyperemia 3- severe hyperemia 4-mucosal damage and bleeding
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2019.
- 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.
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 and Ambu aura i in people with Mucosal Damage, run by Bezmialem Vakif 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 5 inclusion and 7 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 20 Aug 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sinan Yılmaz, Instructor (+905324563023, siyilmaz@bezmialem.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
airway trauma (time frame: up to 1 minute after extubation). 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 20 Aug 2019.