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Comparison is made between standard nasotracheal tubes and a specially designed nasotracheal tube during nasotracheal intubation in children undergoing general anesthesia for dental surgery.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| standard nasotracheal tube | Active Comparator | Nasotracheal intubation using 'standard' side-beveled nasotracheal tubes |
|
| Parker flex-tip nasotracheal tube | Active Comparator | Nasotracheal intubation using 'experimental' flex-tip midline-beveled nasotracheal tubes |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Parker flex-tip nasotracheal tube | Device | specially designed nasotracheal tube used for nasotracheal intubation assess nasopharynx for severity of bleeding grade adenoid size |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Nasotracheal Tube Impingement | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert B Bryskin, MD | Nemours Children's Clinic, Jacksonville, FL | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wolfson Children's Hospital | Jacksonville | Florida | 32207 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Standard Nasotracheal Tube | Nasotracheal intubation using 'standard' side-beveled nasotracheal tubes Standard nasotracheal tube: standard nasotracheal tube for nasotracheal intubation assess nasopharynx for severity of bleeding grade adenoid size |
| FG001 | Parker Flex-tip Nasotracheal Tube | Nasotracheal intubation using 'experimental' flex-tip midline-beveled nasotracheal tubes Parker flex-tip nasotracheal tube: specially designed nasotracheal tube used for nasotracheal intubation assess nasopharynx for severity of bleeding grade adenoid size |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Standard Nasotracheal Tube | Nasotracheal intubation using 'standard' side-beveled nasotracheal tubes Standard nasotracheal tube: standard nasotracheal tube for nasotracheal intubation assess nasopharynx for severity of bleeding grade adenoid size |
| BG001 | Parker Flex-tip Nasotracheal Tube |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Epistaxis | Mucosal damage as quantified by presence and severity of bleeding immediately after passage of the NTT through the nasopharynx. | Posted | Count of Participants | Participants | within approximately 4hrs of surgery (day of surgery) |
|
day of procedure, up to 12 hours
the study did not include experimental equipment or a deviation from the standard of care
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Standard Nasotracheal Tube | Nasotracheal intubation using 'standard' side-beveled nasotracheal tubes Standard nasotracheal tube: standard nasotracheal tube for nasotracheal intubation assess nasopharynx for severity of bleeding grade adenoid size |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Katrin Post-Martens | Nemours | 904-330-9942 | Katrin.Post-Martens@nemours.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 10, 2015 | Dec 6, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D004844 | Epistaxis |
| ID | Term |
|---|---|
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D006470 | Hemorrhage |
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| Standard nasotracheal tube | Device | standard nasotracheal tube for nasotracheal intubation assess nasopharynx for severity of bleeding grade adenoid size |
|
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 | 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 | emergence from anesthesia to meeting discharge criteria, approximately 4hrs |
Nasotracheal intubation using 'experimental' flex-tip midline-beveled nasotracheal tubes Parker flex-tip nasotracheal tube: specially designed nasotracheal tube used for nasotracheal intubation assess nasopharynx for severity of bleeding grade adenoid size |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| BMI | Mean | Standard Deviation | kg/m^2 |
|
|
|
| Secondary | Number of Participants With Nasotracheal Tube Impingement | Presence and degree of severe impingement of the nasotracheal tube during nasotracheal intubation | Posted | Count of Participants | Participants | perioperative, immediate during intervention - expected 2hrs (day of surgery) |
|
|
|
| Secondary | Number of Participants With Postoperative Epistaxis | ongoing nasal bleeding in the recovery unit | Posted | Count of Participants | Participants | Participants will be followed for the duration of the hospital stay, an expected average of 6 hours |
|
|
|
| Secondary | Number of Participants With Postoperative Croup | evidence of glottic edema/injury in the immediate postoperative time frame | Posted | Count of Participants | Participants | end of surgery until time of discharge, approximately 4hrs |
|
|
|
| Secondary | Time to Discharge in Minutes | Posted | Mean | Standard Deviation | minutes | emergence from anesthesia to meeting discharge criteria, approximately 4hrs |
|
|
|
| 0 |
| 38 |
| 0 |
| 38 |
| 0 |
| 38 |
| EG001 | Parker Flex-tip Nasotracheal Tube | Nasotracheal intubation using 'experimental' flex-tip midline-beveled nasotracheal tubes Parker flex-tip nasotracheal tube: specially designed nasotracheal tube used for nasotracheal intubation assess nasopharynx for severity of bleeding grade adenoid size | 0 | 35 | 0 | 35 | 0 | 35 |
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| D010335 |
| Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |