NCT02109211

Brief Summary

The purpose of this study is to see whether altering the angle of the Magill forceps by 45 degrees will affect nasal intubation time in pediatric dental surgery patients. The null hypothesis is that their will be no difference between the nasal intubation times of those patients intubated with the conventional Magill forceps and those intubated with the altered Magill forceps.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
133

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2014

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

First Submitted

Initial submission to the registry

April 7, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 9, 2014

Completed
22 days until next milestone

Study Start

First participant enrolled

May 1, 2014

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
Last Updated

December 8, 2014

Status Verified

December 1, 2014

Enrollment Period

3 months

First QC Date

April 7, 2014

Last Update Submit

December 5, 2014

Conditions

Nasal IntubationDental SurgeryPediatrics

Outcome Measures

Primary Outcomes (1)

  • Time to intubate

    Having a stopwatch to time how long it takes for the intubator to place initiate direct laryngoscopy until the time of detection of end tidal carbon dioxide on the monitor

    Right after measurement

Secondary Outcomes (3)

  • Cormack-Lehane glottis view

    immediately

  • Number of attempts to nasal tracheal intubation

    once intubation completed

  • Number of technique failures

    once intubation is complete

Study Arms (2)

Standard care - Magill forceps

OTHER

Patients will be intubated, as per standard care, with Magill forceps.

Device: Intubation with Magill forceps

Altered Magill forceps

EXPERIMENTAL

Patients will be intubated with modified Magill forceps.

Device: Intubation with altered Magill forceps

Interventions

Intubation with Magill forcepsDEVICE
Standard care - Magill forceps
Intubation with altered Magill forcepsDEVICE
Altered Magill forceps

Eligibility Criteria

AgeUp to 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • age 0-15yrs, ASA \< or = 2, Mallampati \< or = 3, presenting of dental surgery

You may not qualify if:

  • patients at risk for aspiration, upper airway abnormalities, known difficult airway

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Prairieview Surgical Center

Saskatoon, Saskatchewan, S7S0A5, Canada

Location

MeSH Terms

Interventions

Intubation

Intervention Hierarchy (Ancestors)

TherapeuticsInvestigative Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Faculty

Study Record Dates

First Submitted

April 7, 2014

First Posted

April 9, 2014

Study Start

May 1, 2014

Primary Completion

August 1, 2014

Study Completion

August 1, 2014

Last Updated

December 8, 2014

Record last verified: 2014-12

Locations

CA(1)