Does Altering Magill Forceps Affect Nasal Intubation Time

University of Saskatchewan

Status: Completed

Conditions: Pediatrics; Dental Surgery; Nasal Intubation

Treatments: Device: Intubation with Magill forceps; Device: Intubation with altered Magill forceps

Study type: Interventional

Funder types: Other

Identifiers

NCT02109211

13-250

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 133 patients

Sex: All

Ages: Under 15 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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133 participants in 2 patient groups

Standard care - Magill forceps

Other group

Description:

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

Treatment:

Device: Intubation with Magill forceps

Altered Magill forceps

Experimental group

Description:

Patients will be intubated with modified Magill forceps.

Treatment:

Device: Intubation with altered Magill forceps