Epistaxis
Conditions
Keywords
Nasotracheal intubation, adenoid size, epistaxis, nasopharyngeal mucosal injury
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.
Interventions
DEVICEParker flex-tip nasotracheal tube
specially designed nasotracheal tube used for nasotracheal intubation assess nasopharynx for severity of bleeding grade adenoid size
DEVICEStandard nasotracheal tube
standard nasotracheal tube for nasotracheal intubation assess nasopharynx for severity of bleeding grade adenoid size
Sponsors
Nemours Children's Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
3 Years to 11 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Epistaxis | 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
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Nasotracheal Tube Impingement | perioperative, immediate during intervention - expected 2hrs (day of surgery) | Presence and degree of severe impingement of the nasotracheal tube during nasotracheal intubation |
| Number of Participants With Postoperative Epistaxis | Participants will be followed for the duration of the hospital stay, an expected average of 6 hours | ongoing nasal bleeding in the recovery unit |
| Number of Participants With Postoperative Croup | end of surgery until time of discharge, approximately 4hrs | evidence of glottic edema/injury in the immediate postoperative time frame |
| Time to Discharge in Minutes | emergence from anesthesia to meeting discharge criteria, approximately 4hrs | — |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 38 |
| 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 | 35 |
| Total | 73 |
Baseline characteristics
| Characteristic | Standard Nasotracheal Tube | Parker Flex-tip Nasotracheal Tube | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 38 Participants | 35 Participants | 73 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 6.13 years STANDARD_DEVIATION 1.98 | 6.43 years STANDARD_DEVIATION 2.2 | 6.27 years STANDARD_DEVIATION 2.08 |
| BMI | 16.9 kg/m^2 STANDARD_DEVIATION 3.33 | 16.9 kg/m^2 STANDARD_DEVIATION 4.46 | 16.9 kg/m^2 STANDARD_DEVIATION 3.88 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment United States | 38 participants | 35 participants | 73 participants |
| Sex: Female, Male Female | 12 Participants | 11 Participants | 23 Participants |
| Sex: Female, Male Male | 26 Participants | 24 Participants | 50 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 38 | 0 / 35 |
| other Total, other adverse events | 0 / 38 | 0 / 35 |
| serious Total, serious adverse events | 0 / 38 | 0 / 35 |
Outcome results
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.
Time frame: within approximately 4hrs of surgery (day of surgery)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standard Nasotracheal Tube | Number of Participants With Epistaxis | 11 Participants |
| Parker Flex-tip Nasotracheal Tube | Number of Participants With Epistaxis | 2 Participants |
Secondary
Number of Participants With Nasotracheal Tube Impingement
Presence and degree of severe impingement of the nasotracheal tube during nasotracheal intubation
Time frame: perioperative, immediate during intervention - expected 2hrs (day of surgery)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standard Nasotracheal Tube | Number of Participants With Nasotracheal Tube Impingement | 6 Participants |
| Parker Flex-tip Nasotracheal Tube | Number of Participants With Nasotracheal Tube Impingement | 3 Participants |
Secondary
Number of Participants With Postoperative Croup
evidence of glottic edema/injury in the immediate postoperative time frame
Time frame: end of surgery until time of discharge, approximately 4hrs
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standard Nasotracheal Tube | Number of Participants With Postoperative Croup | 0 Participants |
| Parker Flex-tip Nasotracheal Tube | Number of Participants With Postoperative Croup | 1 Participants |
Secondary
Number of Participants With Postoperative Epistaxis
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standard Nasotracheal Tube | Number of Participants With Postoperative Epistaxis | 1 Participants |
| Parker Flex-tip Nasotracheal Tube | Number of Participants With Postoperative Epistaxis | 0 Participants |
Secondary
Time to Discharge in Minutes
Time frame: emergence from anesthesia to meeting discharge criteria, approximately 4hrs
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Nasotracheal Tube | Time to Discharge in Minutes | 32.1 minutes | Standard Deviation 13.5 |
| Parker Flex-tip Nasotracheal Tube | Time to Discharge in Minutes | 30.4 minutes | Standard Deviation 10.8 |