Trial Outcomes & Findings for , "Mucosal Injury During Nasotracheal Intubation for Dental Procedures in Children-does the Tube Design Matter?" (NCT NCT02517294)
NCT ID: NCT02517294
Last Updated: 2024-02-13
Results Overview
Mucosal damage as quantified by presence and severity of bleeding immediately after passage of the NTT through the nasopharynx.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
73 participants
Primary outcome timeframe
within approximately 4hrs of surgery (day of surgery)
Results posted on
2024-02-13
Participant Flow
Participant milestones
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
38
|
35
|
|
Overall Study
COMPLETED
|
38
|
35
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Standard Nasotracheal Tube
n=38 Participants
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
|
Parker Flex-tip Nasotracheal Tube
n=35 Participants
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
|
Total
n=73 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
38 Participants
n=38 Participants
|
35 Participants
n=35 Participants
|
73 Participants
n=73 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=38 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=73 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=38 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=73 Participants
|
|
Age, Continuous
|
6.13 years
STANDARD_DEVIATION 1.98 • n=38 Participants
|
6.43 years
STANDARD_DEVIATION 2.20 • n=35 Participants
|
6.27 years
STANDARD_DEVIATION 2.08 • n=73 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=38 Participants
|
11 Participants
n=35 Participants
|
23 Participants
n=73 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=38 Participants
|
24 Participants
n=35 Participants
|
50 Participants
n=73 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
38 participants
n=38 Participants
|
35 participants
n=35 Participants
|
73 participants
n=73 Participants
|
|
BMI
|
16.9 kg/m^2
STANDARD_DEVIATION 3.33 • n=38 Participants
|
16.9 kg/m^2
STANDARD_DEVIATION 4.46 • n=35 Participants
|
16.9 kg/m^2
STANDARD_DEVIATION 3.88 • n=73 Participants
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Standard Nasotracheal Tube
n=38 Participants
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
|
Parker Flex-tip Nasotracheal Tube
n=35 Participants
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
|
|---|---|---|
|
Number of Participants With Epistaxis
|
11 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: perioperative, immediate during intervention - expected 2hrs (day of surgery)Presence and degree of severe impingement of the nasotracheal tube during nasotracheal intubation
Outcome measures
| Measure |
Standard Nasotracheal Tube
n=38 Participants
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
|
Parker Flex-tip Nasotracheal Tube
n=35 Participants
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
|
|---|---|---|
|
Number of Participants With Nasotracheal Tube Impingement
|
6 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Participants will be followed for the duration of the hospital stay, an expected average of 6 hoursongoing nasal bleeding in the recovery unit
Outcome measures
| Measure |
Standard Nasotracheal Tube
n=38 Participants
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
|
Parker Flex-tip Nasotracheal Tube
n=35 Participants
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
|
|---|---|---|
|
Number of Participants With Postoperative Epistaxis
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: end of surgery until time of discharge, approximately 4hrsevidence of glottic edema/injury in the immediate postoperative time frame
Outcome measures
| Measure |
Standard Nasotracheal Tube
n=38 Participants
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
|
Parker Flex-tip Nasotracheal Tube
n=35 Participants
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
|
|---|---|---|
|
Number of Participants With Postoperative Croup
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: emergence from anesthesia to meeting discharge criteria, approximately 4hrsOutcome measures
| Measure |
Standard Nasotracheal Tube
n=38 Participants
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
|
Parker Flex-tip Nasotracheal Tube
n=35 Participants
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
|
|---|---|---|
|
Time to Discharge in Minutes
|
32.1 minutes
Standard Deviation 13.5
|
30.4 minutes
Standard Deviation 10.8
|
Adverse Events
Standard Nasotracheal Tube
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Parker Flex-tip Nasotracheal Tube
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place