An interventional study of Intubation with Magill forceps and Intubation with altered Magill forceps in Nasal Intubation, Dental Surgery and Pediatrics, sponsored by University of Saskatchewan. Completed at 1 site in Canada. Open to participants aged Up to 15 Years. Per ClinicalTrials.gov, last updated 2014-12-08.
Sponsored by University of Saskatchewan · Not applicable, Interventional, and Supportive care
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.
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.
University of Saskatchewan is the lead sponsor of 237 studies on the registry; 33 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients will be intubated, as per standard care, with Magill forceps.
Device: Intubation with Magill forceps
Patients will be intubated with modified Magill forceps.
Device: Intubation with altered Magill forceps
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
Time frame: Right after measurement
Cormack-Lehane glottis view
what view is attained through laryngoscopy
Time frame: immediately
Number of attempts to nasal tracheal intubation
Time frame: once intubation completed
Number of technique failures
To see which other methods of intubation, if any, were needed/used to successfully intubate patient
Time frame: once intubation is complete
This study is completed, as verified in Dec 2014. You cannot join it, but the record below documents what was studied.
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University of Saskatchewan