, Mucosal Injury During Nasotracheal Intubation for Dental Procedures in Children-does the Tube Design Matter?

Study Overview
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Brief Summary
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Comparison is made between standard nasotracheal tubes and a specially designed nasotracheal tube during nasotracheal intubation in children undergoing general anesthesia for dental surgery.

Detailed Description
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The Parker flex-tip, midline-beveled nasotracheal tube theoretically slides past obstruction in the nasopharynx causing less mucosal damage than standard nasotracheal tubes. The investigators aim to test whether mucosal injury during nasotracheal intubation in children undergoing general anesthesia for dental procedures can thus be minimized taking into consideration adenoid size, and differences in nasopharyngeal diameter.

Official Title
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Mucosal Injury During Nasotracheal Intubation for Dental Procedures in Children-does the Tube Design Matter?

Conditions
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Epistaxis

Intervention / Treatment
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* Device: Parker flex-tip nasotracheal tube
* Device: Standard nasotracheal tube


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: children between the ages of 3-11, ASA 1-3, presenting to Wolfson Children's Hospital (WCH) for dental procedures requiring general anesthesia with nasotracheal intubation. Exclusion Criteria: ASA >3 known bleeding disorders recent or ongoing treatment with blood-thinning medicines frequent epistaxis active URI/congestion/rhinorrhea craniofacial abnormalities prohibiting NTI known difficult airway prior nasal surgery/trauma allergies to any of the medicines used in this study.

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 11 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: standard nasotracheal tube<br>Nasotracheal intubation using 'standard' side-beveled nasotracheal tubes | Device: Standard nasotracheal tube<br>* standard nasotracheal tube for nasotracheal intubation assess nasopharynx for severity of bleeding grade adenoid size<br>|
| Active Comparator: Parker flex-tip nasotracheal tube<br>Nasotracheal intubation using 'experimental' flex-tip midline-beveled nasotracheal tubes | Device: Parker flex-tip nasotracheal tube<br>* specially designed nasotracheal tube used for nasotracheal intubation assess nasopharynx for severity of bleeding grade adenoid size<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Epistaxis | Mucosal damage as quantified by presence and severity of bleeding immediately after passage of the NTT through the nasopharynx. | within approximately 4hrs of surgery (day of surgery) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| nasotracheal tube impingement | Presence and degree of impingement of the nasotracheal tube during nasotracheal intubation | perioperative, immediate during intervention - expected 2hrs (day of surgery) | 
| postoperative epistaxis | ongoing nasal bleeding in the recovery unit | Participants will be followed for the duration of the hospital stay, an expected average of 6 hours | 
| postoperative croup | evidence of glottic edema/injury in the immediate postoperative time frame | end of surgery until time of discharge, approximately 4hrs | 
| time to discharge |  | emergence from anesthesia to meeting discharge criteria, approximately 4hrs | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nasotracheal intubation, adenoid size, epistaxis, nasopharyngeal mucosal injury