NCT02029300

Brief Summary

There are two routes in which a fiberoptic intubation can be performed - oral and nasal. In general, nasal intubation by any conventional method may be the preferred choice for certain procedures such as intra-oral surgeries, or for anatomical reasons such as limited mouth opening. If nasal intubation is not indicated or preferred, then oral intubation is usually performed. This study is looking to explore whether or not the nasal route significantly improves the ease and time for successful fiberoptic intubation compared to the oral route in children less than or equal to 2 years of age. This study will also examine if operator experience influence time to tracheal intubation with either route? The investigators hypothesize that the nasal route of fiberoptic intubation will be faster than the oral route, for both the trainee and the expert, and that there will be minimal differences between experts and trainees with nasal fiberoptic intubation.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2013

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2013

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

November 7, 2013

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 7, 2014

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
Last Updated

May 28, 2014

Status Verified

May 1, 2014

Enrollment Period

4 months

First QC Date

November 7, 2013

Last Update Submit

May 24, 2014

Conditions

Tracheal Intubation

Keywords

pediatricsfiberoptic intubationoral intubationnasal intubationchildren under the age of 2

Outcome Measures

Primary Outcomes (1)

  • Time to fiberoptic intubation

    From disconnection of oxygen to reconnection of oxygen during tracheal intubation

Other Outcomes (4)

  • Time to first glottic view

    during tracheal intubation

  • Time to carinal view

    during tracheal intubation

  • Time to successful intubation

    during tracheal intubation

  • +1 more other outcomes

Study Arms (2)

Nasal Route

OTHER

The nasal route will be when the airway is acquired and secured with a fiberoptic bronchoscope through one of the nares.

Other: Fiberoptic Intubation through the nasal route

Oral Route

OTHER

The oral route will be when the airway is acquired and secured with a fiberoptic bronchoscope through the patient's mouth.

Other: Fiberoptic intubation through the oral route

Interventions

Fiberoptic Intubation through the nasal routeOTHER
Nasal Route
Fiberoptic intubation through the oral routeOTHER
Oral Route

Eligibility Criteria

Age1 Day - 2 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Healthy children ASA I to III
  • Patients less than or equal to 2 years of age
  • Patients with scheduled surgeries in which endotracheal intubation is part of their general anesthetic plan

You may not qualify if:

  • Children with ASA IV or V
  • Children with active respiratory infection, pulmonary disease, a known history of difficult mask ventilation, high suspicion of difficult airway (secondary to congenital syndromes for example), and significant airway abnormalities

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ann & Robert H. Lurie Children's Hospital of Chicago

Chicago, Illinois, 60611, United States

Location

Related Publications (2)

  • Wheeler M, Roth AG, Dsida RM, Rae B, Seshadri R, Sullivan CL, Heffner CL, Cote CJ. Teaching residents pediatric fiberoptic intubation of the trachea: traditional fiberscope with an eyepiece versus a video-assisted technique using a fiberscope with an integrated camera. Anesthesiology. 2004 Oct;101(4):842-6. doi: 10.1097/00000542-200410000-00007.

    PMID: 15448515BACKGROUND

  • Jagannathan N, Sequera-Ramos L, Sohn L, Huang A, Sawardekar A, Wasson N, Miriyala A, De Oliveira GS. Randomized comparison of experts and trainees with nasal and oral fibreoptic intubation in children less than 2 yr of age. Br J Anaesth. 2015 Feb;114(2):290-6. doi: 10.1093/bja/aeu370. Epub 2014 Nov 5.

    PMID: 25377166DERIVED

Study Officials

  • Narasimhan Jagannathan, MD

    Lurie Childrens Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Pediatric Anesthesiologist, Associate Professor of Anesthesiology

Study Record Dates

First Submitted

November 7, 2013

First Posted

January 7, 2014

Study Start

November 1, 2013

Primary Completion

March 1, 2014

Study Completion

March 1, 2014

Last Updated

May 28, 2014

Record last verified: 2014-05

Locations

US(1)