Skip to main content
MedPath Trial logoMedPath TrialMedPath Trial Home
Clinical Trials/CTRI/2019/05/019126
CTRI/2019/05/019126Not yet recruitingNot Applicable

Comparison of the clinical performance of I-gel and Ambu Aura Gain -supra-glottic airway devices in paediatric patients under controlled ventilation.

Ashka V Surve1 site in 1 country60 target enrollmentStarted: May 23, 2019Last updated:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Enrollment
60
Locations
1
Primary Endpoint
The oropharyngeal seal pressure of I-gel is higher than Ambu Aura Gain in their individual studies. Whereas insertion of Ambu aura gain is faster than I-Gel.
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

As newer pediatric sized supra-glottic airway devices like I-gel and Ambu Aura Gain  are  available for use in clinical practice in children.  It is important to evaluate their clinical performance and safety to establish superiority or equivalence to the existing devices. So, we choose this study to evaluate and compare overall performance of I-gel versus Ambu Aura Gain in pediatric patients undergoing general anesthesia.  To compare the clinical performance of   I gel with  Ambu Aura Gain in pediatric population for providing adequate airway seal  under controlled mechanical ventilation under general anesthesia.

Study Design

Study Type
Interventional
Allocation
Computer generated randomization
Masking
Participant Blinded

Eligibility Criteria

Ages
3.00 Year(s) to 10.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • •1.Patients age group 3-10 years 2.Either gender 3.Weight 10-35 kg 4.ASA physical status I/II 5.Patients admitted in SSGH and posted for 6.Elective surgeries requiring general anesthesia ( abdominal surgeries, upper limb surgeries, lower limb surgeries, head and neck surgeries etc.

Exclusion Criteria

  • •1.Patient with risk factors of difficult airway (mouth opening of < 2cm, mallampatti class III and IV, limited neck extension, history of previous difficult tracheal intubation).
  • •2.Patients with recent upper respiratory tract infection.
  • •3.Patient with any known pulmonary and cardiovascular diseases.
  • •4.Patient with any conditions that increase the risk of gastro esophageal regurgitation.
  • •5.Parents or guardian not willing for participation.

Outcomes

Primary Outcomes

The oropharyngeal seal pressure of I-gel is higher than Ambu Aura Gain in their individual studies. Whereas insertion of Ambu aura gain is faster than I-Gel.

Time Frame: at 5 minute after insertion of the device, oropharyngeal leak pressure will be noted.

Secondary Outcomes

  • Secondary outcomes are haemodynamic and respiratory parameters.(These secondary outcomes are observed throughout the duration of surgery.)

Investigators

Sponsor
Ashka V Surve
Sponsor Class
Other [self money]

Study Sites (1)

Loading locations...

Similar Trials

Unknown
Not Applicable
The Effect Of I-Gel And Ambu Aura-I Use On Laryngofaryngeal MucosaMucosal Damage
NCT04062747Bezmialem Vakif University40
Completed
Not Applicable
A Comparison of the I-gel and the Self-pressurised Air-Q Intubating Laryngeal Airway in ChildrenGeneral AnesthesiaSupraglottic Airway Devices
NCT02140008Yonsei University80
Completed
Not Applicable
Comparison of the LMA Protector and the I-gelMechanical Ventilation
NCT03078517SMG-SNU Boramae Medical Center110
Not yet recruiting
Not Applicable
Comparison between The two techniques of I-GEL insertion
CTRI/2025/06/089121Shree Krishna hospital78
Completed
Not Applicable
Evaluation of the i-gel supraglottic airway.1. i-gel<br /> 2. supraglottic airway<br />3. laryngeal mask (larynx masker)<br />4. sore throat (keelpijn).
NL-OMON25310The Netherlands Cancer Institute - Antoni van Leeuwenhoek HospitalPlesmanlaan 1211066 CX Amsterdam240