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

Epistaxis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02517294
• Other study ID #: #15-17
• Status: Completed
• Phase: N/A
• Start date: June 2015
• Est. completion date: August 2019

Study information

• Verified date: January 2024
• Source: Nemours Children's Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 73
• Est. completion date: August 2019
• Est. primary completion date: August 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 11 Years

Eligibility

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.

Related Conditions & MeSH terms

• Epistaxis

Intervention

Device:
• Parker flex-tip nasotracheal tube
specially designed nasotracheal tube used for nasotracheal intubation assess nasopharynx for severity of bleeding grade adenoid size
• Standard nasotracheal tube
standard nasotracheal tube for nasotracheal intubation assess nasopharynx for severity of bleeding grade adenoid size

Locations

Country	Name	City	State
United States	Wolfson Children's Hospital	Jacksonville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Nemours Children's Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With 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	Number of Participants With Nasotracheal Tube Impingement	Presence and degree of severe impingement of the nasotracheal tube during nasotracheal intubation	perioperative, immediate during intervention - expected 2hrs (day of surgery)
Secondary	Number of Participants With 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
Secondary	Number of Participants With Postoperative Croup	evidence of glottic edema/injury in the immediate postoperative time frame	end of surgery until time of discharge, approximately 4hrs
Secondary	Time to Discharge in Minutes		emergence from anesthesia to meeting discharge criteria, approximately 4hrs