Clinical trials: I-gel
the Efficacy and Performance of the Pediatric I-gel Mask
Application of I-gel Laryngeal Mask Airway in Pediatric Patients
Background The laryngeal mask airway (LMA) is a supraglottic airway device ,which is commonly used to manage children's airways, because it is typically easy to use and can avoid problems specific to tracheal intubation.
- Trial name
- NCT03748589
- Testing
- laryngeal mask airway
- Where
- China
- Volunteers
- 413 people
- Sponsor
- Xian Children's Hospital
General Anesthesia
Comparison of AuraGain With I-gel for Pediatric Patients
Children from 6 months to 6 years are randomly allocated into AuraGain group or I-gel group. After anesthetic induction without neuromuscular blocking agent, assigned device in inserted by skillful anesthesiologist.
- Trial name
- NCT03294226
- Testing
- AuraGain, I-gel
- Where
- South Korea
- Volunteers
- 68 people
- Sponsor
- Asan Medical Center
Apnea+Hypopnea, Tracheal Dilatation
Tracheal Dilatation in Pediatric Patients With Acquired Tracheal Stenosis, and the Effects of Apneic Oxygenation
The study presents an alternative method of tracheal dilatation in pediatric patients with acquired tracheal stenosis. Dilatation is performed by the use of balloon catheter connected with manometer, that is bronchoscopic guided…
- Conditions
- Apnea+Hypopnea, Tracheal Dilatation, Igel, Tracheal Stenosis
- Trial name
- NCT05028023
- Testing
- Apneic oxygenation - supplemental high flow oxygen administration by an apneic way
- Where
- Greece
- Volunteers
- 5 people
- Sponsor
- Aristotle University Of Thessaloniki
Tuberous Sclerosis Complex
Clinical Study of NPC-12Y Gel in Patients With Skin Lesions Associated With TSC
The purpose of this study is to investigate the efficacy and safety of NPC-12Y gel compared with placebo for skin lesions associated with tuberous sclerosis.
- Trial name
- NCT05495425
- Testing
- NPC-12Y gel
- Where
- 5 sites in Japan
- Volunteers
- 43 people
- Sponsor
- Nobelpharma
Pediatric ALL, Cardiac Arrest
Effect of IAM With an I-gel® on Ventilation Parameters in Simulated Pediatric OHCA
Pediatric cardiac arrest occurs most in the prehospital setting. Most of them are due to respiratory failure (e.g., trauma, drowning, respiratory distress), where hypoxia leads to cardiac arrest.
- Conditions
- Pediatric ALL, Cardiac Arrest, Cardiopulmonary Arrest, Resuscitation
- Trial name
- NCT05498402
- Testing
- i-gel ® device, bag-valve-mask ventilation
- Where
- 4 sites in Switzerland
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- Geneve TEAM Ambulances
Safety Issues
Safety, Tolerability and Pharmacokinetics of ETD-001 Gel
This is a single-center, randomized, double-blind, placebo-controlled Phase I clinical study, which comprises two parts: Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) in healthy subjects.Three dose groups are…
- Trial name
- ETD-001 gel (NCT07674862)
- Testing
- Dose 1, dose 2, dose 3
- Where
- China
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- Etern Therapeutics Wuxi Limited
General Anesthesia
Distance From the Glottis to the Grille in Children
Ambu AuraGain, I-gel, Air-Q intubating laryngeal airway are the most commonly used supraglottic airway. In children, they can be used as intubation conduits.
- Trial name
- NCT03156166
- Testing
- fiberoptic bronchoscope
- Where
- South Korea
- Volunteers
- 89 people
- Sponsor
- Seoul National University Hospital
Endotracheal Intubation
Comparison of Two Type of Laryngeal Mask : I-Gel & LMA ProSeal
The i-gel is a new supra glottic airway device with a non inflatable cuff and an oesophageal vent. The aim of this study is to compare this device to the LMA ProSeal. The study is approved by the institutional ethic committee.
- Trial name
- I-Gel (NCT00624403)
- Testing
- Laryngeal mask insertion (LMA ProSeal), Laryngeal mask insertion (I-Gel)
- Where
- France
- Volunteers
- 700 people
- Sponsor
- University Hospital, Bordeaux
Pediatric Urologic Surgeries
Comparison of Peak Airway Pressure and Gastric Insufflation in Pressure-Controlled Ventilation or Volume-Controlled Ventilation With I-Gel in Pediatric Patient
The purpose of this study is to compare peak airway pressure and gastric insufflation in Pressure-Controlled Ventilation or Volume-Controlled Ventilation with I-Gel in pediatric patient
- Trial name
- NCT02259569
- Testing
- Pressure-controlled ventilation, Volume-controlled ventilation
- Volunteers
- 34 people
- Sponsor
- Yonsei University
Laryngeal Masks
Comparison of Size 1 I-gel and ProSeal Laryngeal Mask
Objective of this prospective, randomized and controlled study is to compare the performances of recently-released size 1 I-gel and size 1 PLMA proven to be superior to classical LMA with prospective studies.
- Trial name
- NCT01704118
- Testing
- I-gel, ProSeal Laryngeal mask
- Where
- Turkey (Türkiye)
- Volunteers
- 50 people
- Sponsor
- Inonu University
Elective Surgery of Short Duration (Less Than 2 hr) Undergoing General Anesthesia Using Supraglottic Airway
The Comparison of the Clinical Efficacy Between I-gel and LMA-Supreme, the Two Most Recently Developed Supraglottic Airway Devices, in Infants
Although the safety and efficacy of the I gel in children has been shown in several large observational studies, There is no study about comparison of the clinical efficacy between I-gel and LMA-Supreme , in particular sizes 1…
- Trial name
- NCT01863316
- Testing
- I gel, LMA Supreme
- Where
- South Korea
- Volunteers
- 100 people
- Sponsor
- Yonsei University
Seal Pressure
A RANDOMIZED CONTROLED TRAIL COMARING LARYNGEAL TUBE SUCTION DISPOSABLE AND I-gel IN PEDIATRIC PATIENT
Introduction The Laryngeal Tube Suction Disposable LTS-D and the i-gel are a second generation supraglottic airway device SAD, the devices have a drain tube to allow access to the gastrointestinal.
- Trial name
- NCT05503277
- Testing
- LTSD, i-gel
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Bnai Zion Medical Center
Airway Complication of Anaesthesia
The Clinical Efficacy of Recently Developed Supraglottic Airway Device, I-gel™, in Neonates and Infants: Comparison With Classic-laryngeal Mask Airway (c-LMA)
Although the safety and efficacy of the Classic-laryngeal mask airway (c-LMA) in children has been shown in several large observational studies, findings suggest that the smaller-sized c-LMAs, in particular sizes 1 and 1½, are…
- Trial name
- NCT01437137
- Testing
- classic-laryngeal mask airway (c-LMA), i-gel™
- Where
- South Korea
- Volunteers
- 54 people
- Sponsor
- Yonsei University
General Anesthesia
Ambu AuraGain Laryngeal Mask Airway and I-gel in Children
Children aged below 7 years are randomly assigned to AuraGain Group or I-gel group. After anesthetic induction, AuraGain or I-gel is inserted and mechanical ventilation is started.
- Trial name
- NCT03118245
- Testing
- AuraGain, I-gel
- Where
- South Korea
- Volunteers
- 94 people, healthy volunteers welcome
- Sponsor
- Seoul National University Hospital
Laryngeal Masks in Children
A Comparison of the Laryngeal Mask Airway (LMA) Supreme and I-gel in Children
The aim of this randomized prospective study is to compare two single-use laryngeal mask airways with a provision of a gastric drain tube allowing for evacuation of gastric contents, the i-gel and the LMA Supreme, in pediatric…
- Trial name
- NCT01633073
- Testing
- LMA Supreme: control device, i-gel: comparison device
- Where
- United States
- Volunteers
- 170 people, healthy volunteers welcome
- Sponsor
- Ann & Robert H Lurie Children's Hospital of Chicago
Cardiac Arrest, Cardiopulmonary Arrest
Continuous Compressions With Asynchronous Ventilations Using I-gel Device Versus 30:2 Approach During Simulated OHCA
Paramedics and EMT will be recruited among four Emergency Medical Services (EMS) in Switzerland to manage a 10-minutes simulation-based adult out-of-hospital cardiac arrest scenario in teams of two.
- Conditions
- Cardiac Arrest, Cardiopulmonary Arrest, Emergency Medical Services, Resuscitation
- Trial name
- NCT04736446
- Testing
- I-gel® supraglottic device, Face mask ventilation
- Where
- Switzerland
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Geneve TEAM Ambulances
Airway Morbidity
Comparison of Ease of I-gel Insertion With Two Different Techniques in Adults
Study will evaluate the I-gel airway device standard insertion technique versus interventional (modified jaw thurst) insertion technique in adult patients.
- Trial name
- NCT04109898
- Testing
- Supraglottic airway device (I-gel) insertion
- Where
- Pakistan
- Volunteers
- 114 people, healthy volunteers welcome
- Sponsor
- Aga Khan University
Laryngeal Masks
I-Gel vs Ambu Laryngeal Mask Airways in Infants and Children Undergoing Surgical Procedures
This study will guide the anesthetists regarding the appropriate selection of the LMA in neonatal age group based on scientific basis.
- Trial name
- NCT02938039
- Testing
- Ambu LMA, I-Gel LMA
- Volunteers
- 112 people
- Sponsor
- King Saud University
Ultrasound Imaging, Supraglottic Airway Device
Ultrasound Imaging to Validate I-gel Placement in pediatrıc 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…
- Conditions
- Ultrasound Imaging, Supraglottic Airway Device, Fiberoptic Bronchoscopy
- Trial name
- NCT04652466
- Testing
- farukcicekci2
- Where
- Turkey (Türkiye)
- Volunteers
- 110 people, healthy volunteers welcome
- Sponsor
- Selcuk University
Intra Ocular Pressure
Comparison of Intra Ocular Pressure After Insertion of the LMA Supreme and LMA Proseal in Pediatric Patients
The investigators enrolled pediatric patients who are undergoing strabismus surgery. The investigators insert either an I-gel or laryngeal mask airway Supreme and measure the intraocular pressures.
- Trial name
- NCT02508181
- Testing
- I-gel, LMA Supreme
- Where
- Turkey (Türkiye)
- Volunteers
- 57 people
- Sponsor
- Kocaeli University