Back to results, "Mucosal Injury During Nasotracheal Intubation for Dental Procedures in Children-does the Tube Design Matter?"
Primary Purpose
Epistaxis
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Parker flex-tip nasotracheal tube
Standard nasotracheal tube
Sponsored by
About this trial
This is an interventional prevention trial for Epistaxis focused on measuring Nasotracheal intubation, adenoid size, epistaxis, nasopharyngeal mucosal injury
Eligibility Criteria
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.
Sites / Locations
- Wolfson Children's Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
standard nasotracheal tube
Parker flex-tip nasotracheal tube
Arm Description
Nasotracheal intubation using 'standard' side-beveled nasotracheal tubes
Nasotracheal intubation using 'experimental' flex-tip midline-beveled nasotracheal tubes
Outcomes
Primary Outcome Measures
Epistaxis
Mucosal damage as quantified by presence and severity of bleeding immediately after passage of the NTT through the nasopharynx.
Secondary Outcome Measures
nasotracheal tube impingement
Presence and degree of impingement of the nasotracheal tube during nasotracheal intubation
postoperative epistaxis
ongoing nasal bleeding in the recovery unit
postoperative croup
evidence of glottic edema/injury in the immediate postoperative time frame
time to discharge
Full Information
NCT ID
NCT02517294
First Posted
May 22, 2015
Last Updated
August 11, 2023
Sponsor
Nemours Children's Clinic
1. Study Identification
Unique Protocol Identification Number
NCT02517294
Brief Title
, "Mucosal Injury During Nasotracheal Intubation for Dental Procedures in Children-does the Tube Design Matter?"
Official Title
"Mucosal Injury During Nasotracheal Intubation for Dental Procedures in Children-does the Tube Design Matter?"
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
June 2015 (Actual)
Primary Completion Date
August 2019 (Actual)
Study Completion Date
August 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nemours Children's Clinic
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epistaxis
Keywords
Nasotracheal intubation, adenoid size, epistaxis, nasopharyngeal mucosal injury
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
standard nasotracheal tube
Arm Type
Active Comparator
Arm Description
Nasotracheal intubation using 'standard' side-beveled nasotracheal tubes
Arm Title
Parker flex-tip nasotracheal tube
Arm Type
Active Comparator
Arm Description
Nasotracheal intubation using 'experimental' flex-tip midline-beveled nasotracheal tubes
Intervention Type
Device
Intervention Name(s)
Parker flex-tip nasotracheal tube
Intervention Description
specially designed nasotracheal tube used for nasotracheal intubation assess nasopharynx for severity of bleeding grade adenoid size
Intervention Type
Device
Intervention Name(s)
Standard nasotracheal tube
Intervention Description
standard nasotracheal tube for nasotracheal intubation assess nasopharynx for severity of bleeding grade adenoid size
Primary Outcome Measure Information:
Title
Epistaxis
Description
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 Outcome Measure Information:
Title
nasotracheal tube impingement
Description
Presence and degree of impingement of the nasotracheal tube during nasotracheal intubation
Time Frame
perioperative, immediate during intervention - expected 2hrs (day of surgery)
Title
postoperative epistaxis
Description
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
Title
postoperative croup
Description
evidence of glottic edema/injury in the immediate postoperative time frame
Time Frame
end of surgery until time of discharge, approximately 4hrs
Title
time to discharge
Time Frame
emergence from anesthesia to meeting discharge criteria, approximately 4hrs
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert B Bryskin, MD
Organizational Affiliation
Nemours Children's Clinic, Jacksonville, FL
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wolfson Children's Hospital
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32207
Country
United States
12. IPD Sharing Statement
Learn more about this trial
, "Mucosal Injury During Nasotracheal Intubation for Dental Procedures in Children-does the Tube Design Matter?"
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