Does Altering Magill Forceps Affect Nasal Intubation Time

Pediatrics Clinical Trial

Official title:

Does Altering The Magill Forceps Angle By 45 Degrees Alter Nasal Intubation Time In Pediatric Dental Surgery Patients?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02109211
• Other study ID #: 13-250
• Status: Completed
• Phase: N/A
• First received: April 7, 2014
• Last updated: December 5, 2014
• Start date: May 2014
• Est. completion date: August 2014

Study information

• Verified date: December 2014
• Source: University of Saskatchewan
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 133
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 15 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Dental Surgery
• Nasal Intubation
• Pediatrics

Intervention

Device:
• Intubation with Magill forceps

• Intubation with altered Magill forceps

Locations

Country	Name	City	State
Canada	Prairieview Surgical Center	Saskatoon	Saskatchewan

Sponsors (1)

Lead Sponsor	Collaborator
University of Saskatchewan

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Cormack-Lehane glottis view	what view is attained through laryngoscopy	immediately	Yes
Secondary	Number of attempts to nasal tracheal intubation		once intubation completed	Yes
Secondary	Number of technique failures	To see which other methods of intubation, if any, were needed/used to successfully intubate patient	once intubation is complete	Yes