, "Mucosal Injury During Nasotracheal Intubation for Dental Procedures in Children-does the Tube Design Matter?"
- Conditions
- Epistaxis
- Registration Number
- NCT02517294
- Lead Sponsor
- Nemours Children's Clinic
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 73
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Number of Participants With Epistaxis 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 Outcome Measures
Name Time Method Number of Participants With Postoperative Croup end of surgery until time of discharge, approximately 4hrs evidence of glottic edema/injury in the immediate postoperative time frame
Number of Participants With Nasotracheal Tube Impingement perioperative, immediate during intervention - expected 2hrs (day of surgery) Presence and degree of severe impingement of the nasotracheal tube during nasotracheal intubation
Number of Participants With Postoperative Epistaxis Participants will be followed for the duration of the hospital stay, an expected average of 6 hours ongoing nasal bleeding in the recovery unit
Time to Discharge in Minutes emergence from anesthesia to meeting discharge criteria, approximately 4hrs
Related Research Topics
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Trial Locations
- Locations (1)
Wolfson Children's Hospital
🇺🇸Jacksonville, Florida, United States
Wolfson Children's Hospital🇺🇸Jacksonville, Florida, United States