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Does Altering Magill Forceps Affect Nasal Intubation Time

NCT ID: NCT02109211

Last Updated: 2014-12-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

133 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-05-31

Study Completion Date

2014-08-31

Brief Summary

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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.

Detailed Description

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The Magill forceps (MF) is the instrument of choice for nasal tracheal intubation (NTI). It serves as an aid for inserting the endotracheal tube tip past the vocal cords during NTI. NTI is preferred over oral tracheal intubation (ETT) in certain instances such as pediatric dental surgery. This is because NTI permits excellent access to all intraoral structures while reducing risk of inadvertent displacement of an orotracheal tube. Although there is literature looking at MF design alterations to reduce complications and improve its other uses, there is no literature examining the effect of design alterations on time to successful intubate (TTI). Our study premise is based on the concept that a MF is not ideally structured for the pediatric airway anatomy. Knowing that the larynx is considerably anterior in the pediatric airway, we hypothesized that a + 45° angle change 2cm from the tip of the MF will help align the direction the instrument carrying the endotracheal tube with the anatomic direction of the airway and thus help reduce the TTI.. If a reduction in TTI can be shown it would be of significant benefit and could add another tool for NTI. Even though, the current MF has been satisfactory in its use, this should not deter us from looking for opportunities to improve on the current standard. To test this hypothesis, we will include a hundred participants as part of an open label, controlled, single center, and randomized study in which 50 patients will be intubated with the conventional MF and 50 patients will be intubated with the altered MF. We expect the results to show at least a 5 second reduction in TTI and thus be statistically significant with a p value less than 0.05 for our sample size. Our expected conclusion is that a reduced TTI is clinically beneficially as it will reduce apnea time in the pediatric patients, a population with known physiological limitations in respiratory reserve. This, in turn, could point to a reduction in intra-operative and post-operative respiratory complications.

Conditions

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Nasal Intubation Dental Surgery Pediatrics

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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Standard care - Magill forceps

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

Group Type OTHER

Intubation with Magill forceps

Intervention Type DEVICE

Altered Magill forceps

Patients will be intubated with modified Magill forceps.

Group Type EXPERIMENTAL

Intubation with altered Magill forceps

Intervention Type DEVICE

Interventions

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Intubation with Magill forceps

Intervention Type DEVICE

Intubation with altered Magill forceps

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* patients at risk for aspiration, upper airway abnormalities, known difficult airway
Maximum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Saskatchewan

OTHER

Sponsor Role lead

Responsible Party

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William McKay

Faculty

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Prairieview Surgical Center

Saskatoon, Saskatchewan, Canada

Site Status

Countries

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Canada

Other Identifiers

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13-250

Identifier Type: -

Identifier Source: org_study_id