- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02517294
, "Mucosal Injury During Nasotracheal Intubation for Dental Procedures in Children-does the Tube Design Matter?"
"Mucosal Injury During Nasotracheal Intubation for Dental Procedures in Children-does the Tube Design Matter?"
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Robert B Bryskin, MD
- Email: robert.bryskin@nemours.org
Study Locations
-
-
Florida
-
Jacksonville, Florida, United States, 32207
- Wolfson Children's Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: standard nasotracheal tube
Nasotracheal intubation using 'standard' side-beveled nasotracheal tubes
|
standard nasotracheal tube for nasotracheal intubation assess nasopharynx for severity of bleeding grade adenoid size
|
Active Comparator: Parker flex-tip nasotracheal tube
Nasotracheal intubation using 'experimental' flex-tip midline-beveled nasotracheal tubes
|
specially designed nasotracheal tube used for nasotracheal intubation assess nasopharynx for severity of bleeding grade adenoid size
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
within approximately 4hrs of surgery (day of surgery)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
perioperative, immediate during intervention - expected 2hrs (day of surgery)
|
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
|
Participants will be followed for the duration of the hospital stay, an expected average of 6 hours
|
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
|
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
|
emergence from anesthesia to meeting discharge criteria, approximately 4hrs
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Robert B Bryskin, MD, Nemours Children's Clinic, Jacksonville, FL
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- #15-17
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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