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OpenTrials
Completed

NCT Number: NCT02517294

, "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.

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Key information

Conditions

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

Age range

3 year–11 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Wolfson Children's Hospital

Jacksonville, Florida, 32207, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Parker flex-tip nasotracheal tube

Device

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

Standard nasotracheal tube

Device

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

Primary outcomes

  1. Number of Participants With Epistaxis

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

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

Secondary outcomes

  1. Number of Participants With Nasotracheal Tube Impingement

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

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

  2. Number of Participants With Postoperative Epistaxis

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

    ongoing nasal bleeding in the recovery unit

  3. Number of Participants With Postoperative Croup

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

    evidence of glottic edema/injury in the immediate postoperative time frame

  4. Time to Discharge in Minutes

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

Sponsors and collaborators

Lead sponsor

Nemours Children's Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Aug 7, 2015
Registry last updated
Feb 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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