"Mucosal Injury During Nasotracheal Intubation for Dental Procedures in Children-does the Tube Design Matter?"
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Nemours Children's Clinic
- Enrollment
- 73
- Locations
- 2
- Primary Endpoint
- Number of Participants With Epistaxis
Study Overview
Brief Summary
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
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 3 Years to 11 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •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.
Outcomes
Primary Outcomes
Number of Participants With Epistaxis
Time Frame: within approximately 4hrs of surgery (day of surgery)
Mucosal damage as quantified by presence and severity of bleeding immediately after passage of the NTT through the nasopharynx.
Secondary Outcomes
- Number of Participants With Postoperative Croup(end of surgery until time of discharge, approximately 4hrs)
- Number of Participants With Nasotracheal Tube Impingement(perioperative, immediate during intervention - expected 2hrs (day of surgery))
- Number of Participants With Postoperative Epistaxis(Participants will be followed for the duration of the hospital stay, an expected average of 6 hours)
- Time to Discharge in Minutes(emergence from anesthesia to meeting discharge criteria, approximately 4hrs)