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

Not Applicable

Completed

• Conditions: Epistaxis
• Interventions: Device: Standard nasotracheal tube; Device: Parker flex-tip nasotracheal tube

• 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.

Study Timeline

• Study First Submitted: 2015-05-22
• Study Start: 2015-06
• Study First Submitted QC: 2015-08-04
• Study First Posted: 2015-08-07
• Primary Completion: 2019-08
• Study Completion: 2019-08
• Results First Submitted: 2023-12-06
• Status Verified: 2024-01
• Results First Submitted QC: 2024-01-23
• Last Update Submitted: 2024-01-23
• Results First Posted: 2024-02-13
• Last Update Posted: 2024-02-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 73

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.

Read More

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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
standard nasotracheal tube	Standard nasotracheal tube	Nasotracheal intubation using 'standard' side-beveled nasotracheal tubes
Parker flex-tip nasotracheal tube	Parker flex-tip nasotracheal tube	Nasotracheal intubation using 'experimental' flex-tip midline-beveled nasotracheal tubes

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

Trial Locations

Locations (1)

Wolfson Children's Hospital; 🇺🇸 Jacksonville, Florida, United States