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CompletedNCT02517294Updated Feb 13, 2024Results posted

, "Mucosal Injury During Nasotracheal Intubation for Dental Procedures in Children-does the Tube Design Matter?"

An interventional study of Parker flex-tip nasotracheal tube and Standard nasotracheal tube in Epistaxis, sponsored by Nemours Children's Clinic. Completed at 1 site in United States. Open to participants aged 3 Years to 11 Years. Per ClinicalTrials.gov, last updated 2024-02-13.

Sponsored by Nemours Children's Clinic · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
73
Allocation
Randomized
Ages
3 Years to 11 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Epistaxis

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Keywords

  • Nasotracheal intubation
  • adenoid size
  • epistaxis
  • nasopharyngeal mucosal injury
03

In context

Epistaxis

96 studies on the registry are indexed under Epistaxis; 22 are open to participants now.

This study's enrollment of 73 is above the median of 64 across 81 interventional studies indexed under Epistaxis.

Browse Epistaxis studies →

Lead sponsor

Nemours Children's Clinic is the lead sponsor of 130 studies on the registry; 26 are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 6 (67%) have results posted.

Browse Nemours Children's Clinic studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
3 Years to 11 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
73 participants (actual)

Study arms

  • Active comparator
    standard nasotracheal tube

    Nasotracheal intubation using 'standard' side-beveled nasotracheal tubes

    Device: Standard nasotracheal tube

  • Active comparator
    Parker flex-tip nasotracheal tube

    Nasotracheal intubation using 'experimental' flex-tip midline-beveled nasotracheal tubes

    Device: Parker flex-tip nasotracheal tube

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

06

What researchers measure

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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)

  2. 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

  3. 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

  4. Time to Discharge in Minutes

    Time frame: emergence from anesthesia to meeting discharge criteria, approximately 4hrs

07

Results

Posted Feb 13, 2024

Participant flow

Participant flow — Overall Study
MilestoneStandard Nasotracheal TubeParker Flex-tip Nasotracheal Tube
Started3835
Completed3835
Not completed00

Outcome measures

PrimaryNumber 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)
Reported as:
Count of participants · Participants
Number of Participants With Epistaxis
ParticipantsStandard Nasotracheal TubeParker Flex-tip Nasotracheal Tube
Number of Participants With Epistaxis112
SecondaryNumber 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)
Reported as:
Count of participants · Participants
Number of Participants With Nasotracheal Tube Impingement
ParticipantsStandard Nasotracheal TubeParker Flex-tip Nasotracheal Tube
Number of Participants With Nasotracheal Tube Impingement63
SecondaryNumber 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
Reported as:
Count of participants · Participants
Number of Participants With Postoperative Epistaxis
ParticipantsStandard Nasotracheal TubeParker Flex-tip Nasotracheal Tube
Number of Participants With Postoperative Epistaxis10
SecondaryNumber 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
Reported as:
Count of participants · Participants
Number of Participants With Postoperative Croup
ParticipantsStandard Nasotracheal TubeParker Flex-tip Nasotracheal Tube
Number of Participants With Postoperative Croup01
SecondaryTime to Discharge in Minutes
Time frame:
emergence from anesthesia to meeting discharge criteria, approximately 4hrs
Reported as:
Mean · minutes
Time to Discharge in Minutes
minutesStandard Nasotracheal TubeParker Flex-tip Nasotracheal Tube
Time to Discharge in Minutes32.1 ± 13.530.4 ± 10.8

Adverse events

Collected over day of procedure, up to 12 hours. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Standard Nasotracheal Tube0/38 (0%)0/38 (0%)0/38 (0%)
Parker Flex-tip Nasotracheal Tube0/35 (0%)0/35 (0%)0/35 (0%)

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Standard Nasotracheal TubeParker Flex-tip Nasotracheal TubeTotal
<=18 years383573
Between 18 and 65 years000
>=65 years000
Age, Continuous
Age, Continuous(years)Standard Nasotracheal TubeParker Flex-tip Nasotracheal TubeTotal
Mean6.13 ± 1.986.43 ± 2.206.27 ± 2.08
Sex: Female, Male
Sex: Female, Male(Participants)Standard Nasotracheal TubeParker Flex-tip Nasotracheal TubeTotal
Female121123
Male262450
Race and Ethnicity Not Collected
Race and Ethnicity Not Collected(Participants)Standard Nasotracheal TubeParker Flex-tip Nasotracheal TubeTotal
Count of participants——0
Region of Enrollment
Region of Enrollment(participants)Standard Nasotracheal TubeParker Flex-tip Nasotracheal TubeTotal
United States383573
BMI
BMI(kg/m^2)Standard Nasotracheal TubeParker Flex-tip Nasotracheal TubeTotal
Mean16.9 ± 3.3316.9 ± 4.4616.9 ± 3.88
08

Study locations

1 site
  • Wolfson Children's Hospital
    Jacksonville, Florida 32207, United States
09

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jun 2015 to primary completion in Aug 2019, 50 months.

Results were first posted in Feb 2024, 4 years 6 months after primary completion.

Of 24 interventional studies with no phase under Epistaxis, half reached primary completion within 14 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 25. This study's 50 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
May 22, 2015
First posted
Aug 7, 2015
StartActual
Jun 2015
Primary completionActual
Aug 2019
CompletionActual
Aug 2019
Results first posted
Feb 13, 2024
Last update
Feb 13, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 13, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02517294
Lead sponsor
Nemours Children's Clinic
Responsible party
Sponsor
First posted
Aug 7, 2015
Start date
Jun 2015
Primary completion
Aug 2019
Completion
Aug 2019
Results posted
Feb 13, 2024
Last update
Feb 13, 2024

Study contacts

Robert B Bryskin, MD
principal investigator · Nemours Children's Clinic, Jacksonville, FL

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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