EpistaxisNCT02517294
, "Mucosal Injury During Nasotracheal Intubation for Dental Procedures in Children-does the Tube Design Matter?"
A study testing Parker flex-tip nasotracheal tube and Standard nasotracheal tube in people with Epistaxis, run by Nemours Children's Clinic at 1 site in United States.
Trial 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 more about this study
- Who is it for?
- Ages 3 to 11 years
- Conditions the study is for
- Epistaxis
- What is being tested?
- Parker flex-tip nasotracheal tube and Standard nasotracheal tube
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 73 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2015to Aug 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- ASA >3
- known bleeding disorders
- recent or ongoing treatment with blood-thinning medicines
- frequent epistaxis
- active URI/congestion/rhinorrhea
- craniofacial abnormalities prohibiting NTI
Show all 9Show fewer
- known difficult airway
- prior nasal surgery/trauma
- allergies to any of the medicines used in this study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Wolfson Children's Hospital
Jacksonville, Florida, 32207
About this study
Official title: "Mucosal Injury During Nasotracheal Intubation for Dental Procedures in Children-does the Tube Design Matter?"
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.
- Conditions
- Epistaxis
- Being tested
- Parker flex-tip nasotracheal tube, Standard nasotracheal tube
- Keywords
- Nasotracheal intubation, adenoid size, epistaxis, nasopharyngeal mucosal injury
- Medical subject headings
- Epistaxis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parker flex-tip nasotracheal tubeDevice
specially designed nasotracheal tube used for nasotracheal intubation assess nasopharynx for severity of bleeding grade adenoid size
Standard nasotracheal tubeDevice
standard nasotracheal tube for nasotracheal intubation assess nasopharynx for severity of bleeding grade adenoid size
| Study group | Role | What they receive |
|---|---|---|
| standard nasotracheal tube | Active comparator | Nasotracheal intubation using 'standard' side-beveled nasotracheal tubes Receives: Device: Standard nasotracheal tube |
| Parker flex-tip nasotracheal tube | Active comparator | Nasotracheal intubation using 'experimental' flex-tip midline-beveled nasotracheal tubes Receives: Device: Parker flex-tip nasotracheal tube |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Epistaxis
Mucosal damage as quantified by presence and severity of bleeding immediately after passage of the NTT through the nasopharynx.
Measured: within approximately 4hrs of surgery (day of surgery)
Secondary outcomes (4)
Number of Participants With Nasotracheal Tube Impingement
Presence and degree of severe impingement of the nasotracheal tube during nasotracheal intubation
Measured: perioperative, immediate during intervention - expected 2hrs (day of surgery)
Number of Participants With Postoperative Epistaxis
ongoing nasal bleeding in the recovery unit
Measured: 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
Measured: end of surgery until time of discharge, approximately 4hrs
Time to Discharge in Minutes
Measured: emergence from anesthesia to meeting discharge criteria, approximately 4hrs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2015 (estimated)
- Study startJun 2015
- Primary completionAug 2019
- Study completionAug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for EpistaxisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nemours Children's Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Robert B Bryskin, MD, Principal investigator, Nemours Children's Clinic, Jacksonville, FL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02517294
- Sponsor's protocol ID
- #15-17
- Status last verified
- Jan 2024
- First submitted
- 22 May 2015
- Last updated
- 13 Feb 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Mucosal Injury During Nasotracheal Intubation for Dental Procedures in Children-does the Tube Design Matter?"
- ClinicalTrials.gov ID
- NCT02517294
- Acronym / sponsor ID
- #15-17
- Conditions
- Epistaxis
- Keywords
- Nasotracheal intubation, adenoid size, epistaxis, nasopharyngeal mucosal injury
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Nemours Children's ClinicUniversity, hospital or other
- Study start
- Jun 2015 (actual)
- Primary completion
- Aug 2019 (actual)
- Study completion
- Aug 2019 (actual)
- First posted
- 7 Aug 2015 (estimated)
- Results
- Posted 13 Feb 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| standard nasotracheal tube | Active comparator | Device: Standard nasotracheal tubeNasotracheal intubation using 'standard' side-beveled nasotracheal tubes |
| Parker flex-tip nasotracheal tube | Active comparator | Device: Parker flex-tip nasotracheal tubeNasotracheal intubation using 'experimental' flex-tip midline-beveled nasotracheal tubes |
Who may qualify
- Ages
- 3 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (9 listed)
- ASA >3
- known bleeding disorders
- recent or ongoing treatment with blood-thinning medicines
- frequent epistaxis
- active URI/congestion/rhinorrhea
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Parker flex-tip nasotracheal tubespecially designed nasotracheal tube used for nasotracheal intubation assess nasopharynx for severity of bleeding grade adenoid size | Device | Parker flex-tip nasotracheal tube |
| Standard nasotracheal tubestandard nasotracheal tube for nasotracheal intubation assess nasopharynx for severity of bleeding grade adenoid size | Device | standard nasotracheal tube |
Primary outcome
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.
4 secondary outcomes
Number of Participants With Nasotracheal Tube Impingement
Time frame: 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
Number of Participants With Postoperative Croup
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Epistaxis
Not yet recruitingPhase 1
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Active, not recruitingPhase 1/2
A Study to Evaluate ALN-6400 in Healthy Volunteers and Patients With Hereditary Hemorrhagic Telangiectasia (HHT)
Hereditary Hemorrhagic Telangiectasia
Not yet recruitingPhase 2
Effect of Vitamin C Administration on Intraoperative Bleeding in Patients Undergoing Sinusoscopy
Chronic Rhinosinusitis, Intraoperative Bleeding
Recruiting
Comparative Study - Transseptal Suture Technique Verses Anterior Nasal Packing After Septoplasty
Deviated Nasal Septum, Postoperative Nasal Pain
RecruitingPhase 3
RADA16 for Adult Tonsillectomy
Postoperative Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert B Bryskin, MD principal investigator
Nemours Children's Clinic, Jacksonville, FL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Parker flex-tip nasotracheal tube and Standard nasotracheal tube in people with Epistaxis, run by Nemours Children's Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Feb 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Epistaxis (time frame: within approximately 4hrs of surgery (day of surgery)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2024.