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

NCT02517294 | Completed Results

• 1 other identifier: #15-17
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 1

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.

Conditions

Epistaxis

Keywords

Nasotracheal intubation; adenoid size; epistaxis; nasopharyngeal mucosal injury

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Number of Participants With Nasotracheal Tube Impingement

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

• Number of Participants With Postoperative Epistaxis

  Participants will be followed for the duration of the hospital stay, an expected average of 6 hours

• Number of Participants With Postoperative Croup

  end of surgery until time of discharge, approximately 4hrs

• Time to Discharge in Minutes

  emergence from anesthesia to meeting discharge criteria, approximately 4hrs

Study Arms (2)

standard nasotracheal tube

ACTIVE COMPARATOR

Nasotracheal intubation using 'standard' side-beveled nasotracheal tubes

Device: Standard nasotracheal tube

Parker flex-tip nasotracheal tube

ACTIVE COMPARATOR

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

Device: Parker flex-tip nasotracheal tube

Interventions

Parker flex-tip nasotracheal tube DEVICE

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

Parker flex-tip nasotracheal tube

Standard nasotracheal tube DEVICE

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

standard nasotracheal tube

Eligibility Criteria

• Age: 3 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nemours Children's Clinic: lead

Study Sites (1)

Wolfson Children's Hospital

Jacksonville, Florida, 32207, United States

Location

MeSH Terms

Conditions

Epistaxis

Condition Hierarchy (Ancestors)

Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Respiratory; Signs and Symptoms

Results Point of Contact

• Title: Dr Katrin Post-Martens
• Organization: Nemours

Katrin.Post-Martens@nemours.org

904-330-9942

Study Officials

• Robert B Bryskin, MD

  Nemours Children's Clinic, Jacksonville, FL

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2015
• First Posted: August 7, 2015
• Study Start: June 1, 2015
• Primary Completion: August 1, 2019
• Study Completion: August 1, 2019
• Last Updated: February 13, 2024
• Results First Posted: February 13, 2024

Record last verified: 2024-01

Locations

US (1)