Blind Versus Fiberoptic Intubation Through I-GEL

NCT03086941 | Completed DMC

• 1 other identifier: N-60-2016
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

Brief Summary

Aim of the work To compare between use of I-gel as a conduit for blind intubation and as a conduit for fiberoptic guided intubation in children and also aim to validate the use of I-gel as conduit for blind intubation in absence of fiberoptic or lack of experience of its use. Objectives:

• To validate I-gel use as blind intubating conduit in children.
• To Estimate the duration of blind intubation using I-gel and duration of fiberoptic guided intubation through I-gel. Ethical Considerations The study protocol will be approved by the Research Ethics Committee.

Conditions

I-gel

Outcome Measures

Primary Outcomes (1)

• The success rate of first attempt intubation

  assessing the success rate of first attempt to insert the endotracheal tube through I-gel either blindly or by a fiberscope

  The success rate for insertion will be recorded 5 minutes after induction of anesthesia

Study Arms (2)

Group B(blibd)

ACTIVE COMPARATOR

group B (blind); an appropriate size endotracheal tube will be introduced through I-gel blindly. Only smooth intubation without force together with manoeuvres necessary to correct the position of tracheal tube will be allowed. Only one attempt of blind intubation is allowed to avoid airway injury. Any resistance to first attempt tube insertion will indicate failure of blind tube insertion.

Device: I-gel

Group C(control)

ACTIVE COMPARATOR

group C (control), a paediatric fibrescope will be primed with an appropriate size tracheal tube. The fibrescope will be introduced through I-gel and guide tracheal intubation. After insertion of tube and confirmation of position, the fiberscope will be removed

Device: I-gel

Interventions

I-gel DEVICE

To compare between use of I-gel as a conduit for blind intubation and as a conduit for fiberoptic guided intubation in children. We also aim to validate the use of I-gel as conduit for blind intubation in absence of fiberoptic or lack of experience of its use.

Group B(blibd); Group C(control)

Eligibility Criteria

• Age: 2 Years - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• ASA physical status I-II
• Age (2-6)

You may not qualify if:

• Known difficulty of intubation. (Airway assessment clinically for presence of retrognathia, small mandibular cavity, limited neck or mandibular mobility and presence of syndromes associated with facial abnormalities e.g Pierre Robin sequence, Treacher Collins, Hurler's Hunter's syndrome (mucopolysaccharidoses), Beckwith-Wiedemann syndrome and Down's syndrome.)
• Emergency surgery.
• Risk of aspiration (e.g; full stomach, GERD, CHPS).
• Respiratory tract infections.
• Children not fitted with I-Gel.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Children Hospital of Cairo University

Cairo, 11956, Egypt

Location

Study Officials

• Amr Sherbeny, Master

  Research Ethics Committee

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer of anesthesia

Study Record Dates

• First Submitted: March 11, 2017
• First Posted: March 22, 2017
• Study Start: September 1, 2016
• Primary Completion: November 1, 2017
• Study Completion: December 20, 2017
• Last Updated: December 27, 2017

Record last verified: 2017-12

Locations

EG (1)