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

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

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

Study Overview

• Status: Completed
• Conditions: Epistaxis
• Intervention / Treatment: Device: Standard nasotracheal tube; Device: Parker flex-tip nasotracheal tube

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 Type: Interventional
• Enrollment (Actual): 73
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Jacksonville, Florida, United States, 32207
      • Wolfson Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 11 years (Child)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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
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
Time to Discharge in Minutes		emergence from anesthesia to meeting discharge criteria, approximately 4hrs

Collaborators and Investigators

• Sponsor: Nemours Children's Clinic
• Investigators: Principal Investigator: Robert B Bryskin, MD, Nemours Children's Clinic, Jacksonville, FL

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2015
• Primary Completion (Actual): August 1, 2019
• Study Completion (Actual): August 1, 2019

Study Registration Dates

• First Submitted: May 22, 2015
• First Submitted That Met QC Criteria: August 4, 2015
• First Posted (Estimated): August 7, 2015

Study Record Updates

• Last Update Posted (Actual): February 13, 2024
• Last Update Submitted That Met QC Criteria: January 23, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: epistaxis; Nasotracheal intubation; adenoid size; nasopharyngeal mucosal injury
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Hemorrhage; Otorhinolaryngologic Diseases; Signs and Symptoms, Respiratory; Nose Diseases; Epistaxis
• Other Study ID Numbers: #15-17