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

Nemours Children's Health

Status: Completed

Conditions: Epistaxis

Treatments: Device: Parker flex-tip nasotracheal tube; Device: Standard nasotracheal tube

Study type: Interventional

Funder types: Other

Identifiers

NCT02517294

#15-17

Details and patient eligibility

About

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

Full 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.

Enrollment: 73 patients

Sex: All

Ages: 3 to 11 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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73 participants in 2 patient groups

standard nasotracheal tube

Active Comparator group

Description:

Nasotracheal intubation using 'standard' side-beveled nasotracheal tubes

Treatment:

Device: Standard nasotracheal tube

Parker flex-tip nasotracheal tube

Active Comparator group

Description:

Nasotracheal intubation using 'experimental' flex-tip midline-beveled nasotracheal tubes

Treatment:

Device: Parker flex-tip nasotracheal tube