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

Nemours Children's Clinic73 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

Conditions

Epistaxis

Interventions

Parker flex-tip nasotracheal tubeDEVICE

specially designed nasotracheal tube used for nasotracheal intubation assess nasopharynx for severity of bleeding grade adenoid size

Standard nasotracheal tubeDEVICE

standard nasotracheal tube for nasotracheal intubation assess nasopharynx for severity of bleeding grade adenoid size

Eligibility

Sex: ALLMin age: 3 YearsMax age: 11 Years

Medical Language ↔ Plain English

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.

Locations (1)

Wolfson Children's Hospital

Jacksonville, Florida, United States

Outcomes

Primary Outcomes

Number of Participants With Epistaxis

Mucosal damage as quantified by presence and severity of bleeding immediately after passage of the NTT through the nasopharynx.

Time frame: within approximately 4hrs of surgery (day of surgery)

Secondary Outcomes

Number of Participants With Nasotracheal Tube Impingement

Presence and degree of severe impingement of the nasotracheal tube during nasotracheal intubation

Time frame: perioperative, immediate during intervention - expected 2hrs (day of surgery)

Number of Participants With Postoperative Epistaxis

ongoing nasal bleeding in the recovery unit

Time frame: 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

Time frame: end of surgery until time of discharge, approximately 4hrs

Time to Discharge in Minutes

Time frame: emergence from anesthesia to meeting discharge criteria, approximately 4hrs

Data from ClinicalTrials.gov

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