Application of I-gel Laryngeal Mask Airway in Pediatric Patients

NCT03748589 | Completed DMC

• 1 other identifier: 2018008
• Study Type: interventional
• Target: 413
• Locations: 1 country
• Sites: 1

Brief Summary

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. Since the LMA was introduced into clinical practice in 1988 , various types of LMAs have been developed, the safety and efficacy of which have been established in both adults and children.The paediatric i-gel is a relatively new and disposable supraglottic airway device for children, which is made of a soft gel-like elastomer with a non-inflatable cuff and a channel for gastric catheter placement . It does not require cuff inflation ,reducing the complications associated with compression trauma and high cuff pressure . Medical-grade thermoplastic elastomer creates a more intimate interface for interacting with supraglottic tissue. The usage of i-gel mask is more common in adults ,though a large scale study focusing on children is lacking. Objectives: To evaluate the efficacy and performance of the pediatric i-gel mask Methods: From November 2018 to March 2019, subjects are selected from patients who undergo elective surgery at Xi'an Children's Hospital, within the age of 0 to 108 months old, with an American Society of Anesthesiologists physical status I or II .They were assigned into four groups according to their weight. Four groups are : 2-5 kg (group 1#), 5.1-12.0 kg (group 1.5#), 10-25kg (group 2#) 25-35kg(group 2.5#). The primary outcome is the clinical performance of the airways: the rate of insertion at first attempt,the ease of insertion,the insertion time,the oropharyngeal leak pressure(OLP),the fibreoptic view and the ease of gastric tube insertion. The secondary outcome is the frequency of other perioperative complications as listed in the detail information section.

Conditions

the Efficacy and Performance of the Pediatric I-gel Mask

Keywords

i-gel; pediatric; laryngeal mask airway; children

Outcome Measures

Primary Outcomes (1)

• Oropharyngeal leak pressure

  reading the airway pressure on the monitor in the anesthesia machine

  At 5 min after the insertion of i-gel protector

Secondary Outcomes (5)

• insertion time

  During the insertion of i-gel protector

• ease of insertion

  during the insertion of i-gel protector

• fiberoptic view

  At 15 min after the insertion of i-gel protector

• the rate of successful insertion at first attempt

  During the first attempt insertion of i-gel protector

• the ease of gastric tube insertion

  At 25 min after the insertion of i-gel protector

Study Arms (4)

airway type 1

EXPERIMENTAL

The children weighed between 2-5kg are assigned into this group,they are allocated with i-gel laryngeal mask airway type 1

Device: laryngeal mask airway

airway type 1.5

EXPERIMENTAL

The children weighed between 5-12kg are assigned into this group,they are allocated with i-gel laryngeal mask airway type 1.5

Device: laryngeal mask airway

airway type 2

EXPERIMENTAL

The children weighed between 10-25kg are assigned into this group,they are allocated with i-gel laryngeal mask airway type 2

Device: laryngeal mask airway

airway type 2.5

EXPERIMENTAL

The children weighed between 25-35kg are assigned into this group,they are allocated with i-gel laryngeal mask airway type 2.5

Device: laryngeal mask airway

Interventions

laryngeal mask airway DEVICE

i-gel laryngeal mask airway is a supraglottic airway device made from a medical grade thermoplastic elastomer , is a non-inflatable device to create anatomical seal of the pharyngeal, laryngeal and perilaryngeal structures and avoid compression trauma.

Also known as: i-gel

airway type 1; airway type 1.5; airway type 2; airway type 2.5

Eligibility Criteria

• Age: 1 Day - 108 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Weight between 2 to 35 kg ASA physical status Ι or Ⅱ elective surgery operation time not longer than four hours general anesthesia

You may not qualify if:

• a history of upper respiratory tract infection two weeks before operation risk of aspiration (such as non-fasting status , gastroesophageal reflux disease and hiatus hernia) lung diseases limited head-neck movements those refusing to participate children whose EEG showing bradycardia and conduction block

Sponsors & Collaborators

• Xian Children's Hospital: lead

Study Sites (1)

Xi'an Children's Hospital

Xi'an, Shaanxi, 710000, China

Location

Related Publications (11)

• Banerjee G, Jain D, Bala I, Gandhi K, Samujh R. Comparison of the ProSeal laryngeal mask airway with the I-Gel in the different head-and-neck positions in anaesthetised paralysed children: A randomised controlled trial. Indian J Anaesth. 2018 Feb;62(2):103-108. doi: 10.4103/ija.IJA_594_17.

  PMID: 29491514 BACKGROUND

• Lee YC, Yoon KS, Park SY, Choi SR, Chung CJ. A comparison of i-gel and Laryngeal Mask Airway Supreme during general anesthesia in infants. Korean J Anesthesiol. 2018 Feb;71(1):37-42. doi: 10.4097/kjae.2018.71.1.37. Epub 2017 Aug 14.

  PMID: 29441173 BACKGROUND

• Alzahem AM, Aqil M, Alzahrani TA, Aljazaeri AH. Erratum: Ambu AuraOnce versus i-gel laryngeal mask airway in infants and children undergoing surgical procedures. A randomized controlled trial. Saudi Med J. 2017 Dec;38(12):1267. No abstract available.

  PMID: 29209682 BACKGROUND

• Yang GZ, Xue FS, Li HX, Liu YY. Comparing i-gel and Ambu AuraOnce laryngeal mask airway in pediatric patients. Saudi Med J. 2017 Dec;38(12):1262-1263. doi: 10.15537/smj.2017.12.20856.

  PMID: 29209679 BACKGROUND

• Bhattacharjee S, Som A, Maitra S. Comparison of LMA Supreme with i-gel and LMA ProSeal in children for airway management during general anaesthesia: A meta-analysis of randomized controlled trials. J Clin Anesth. 2017 Sep;41:5-10. doi: 10.1016/j.jclinane.2017.04.019. Epub 2017 Jun 1.

  PMID: 28802606 BACKGROUND

• Park JH, Kim JY, Park K, Kil HK. A randomized comparison of volume- and pressure-controlled ventilation in children with the i-gel: Effects on peak inspiratory pressure, oropharyngeal leak pressure, and gastric insufflation. Medicine (Baltimore). 2017 May;96(18):e6772. doi: 10.1097/MD.0000000000006772.

  PMID: 28471973 BACKGROUND

• Alzahem AM, Aqil M, Alzahrani TA, Aljazaeri AH. Ambu AuraOnce versus i-gel laryngeal mask airway in infants and children undergoing surgical procedures. A randomized controlled trial. Saudi Med J. 2017 May;38(5):482-490. doi: 10.15537/smj.2017.5.17960.

  PMID: 28439597 BACKGROUND

• Jain D, Ghai B, Gandhi K, Banerjee G, Bala I, Samujh R. Evaluation of I-Gel size 2 airway in different degrees of neck flexion in anesthetized children - a prospective, self-controlled trial. Paediatr Anaesth. 2016 Dec;26(12):1136-1141. doi: 10.1111/pan.13001. Epub 2016 Oct 25.

  PMID: 27779349 BACKGROUND

• Nirupa R, Gombar S, Ahuja V, Sharma P. A randomised trial to compare i-gel and ProSeal laryngeal mask airway for airway management in paediatric patients. Indian J Anaesth. 2016 Oct;60(10):726-731. doi: 10.4103/0019-5049.191670.

  PMID: 27761035 BACKGROUND

• Gu Z, Jin Q, Liu J, Chen L. Observation of ventilation effects of I-gel, Supreme and Ambu AuraOnce with respiratory dynamics monitoring in small children. J Clin Monit Comput. 2017 Oct;31(5):1035-1041. doi: 10.1007/s10877-016-9917-6. Epub 2016 Aug 4.

  PMID: 27492428 BACKGROUND

• El-Boghdadly K, Bailey CR, Wiles MD. Postoperative sore throat: a systematic review. Anaesthesia. 2016 Jun;71(6):706-17. doi: 10.1111/anae.13438. Epub 2016 Mar 28.

  PMID: 27158989 BACKGROUND

MeSH Terms

Interventions

Laryngeal Masks

Intervention Hierarchy (Ancestors)

Intubation, Intratracheal; Airway Management; Therapeutics; Intubation; Investigative Techniques; Masks; Protective Devices; Equipment and Supplies; Personal Protective Equipment; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• fang li yang, doctor

  Xian Children's Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2018
• First Posted: November 21, 2018
• Study Start: December 12, 2018
• Primary Completion: September 30, 2019
• Study Completion: September 30, 2019
• Last Updated: August 31, 2020

Record last verified: 2018-12

Locations

CN (1)