Anesthesia Intubation ComplicationNCT03462732
Nasotracheal Tube Stenting by Nelaton Catheter in Pediatric Dental Surgery
A study testing Endotracheal tube and Nelaton catheter in people with Anesthesia Intubation Complication, run by Ain Shams University at 1 site in Egypt.
Trial summary
The value of this study is to compare between stented endotracheal tube with nelaton catheter and non stented tube as regard nasotracheal related complications as epistaxis and nasal cavity injury. Read more about this study
- Who is it for?
- Ages 3 to 9 years
- Conditions the study is for
- Anesthesia Intubation Complication
- What is being tested?
- Endotracheal tube and Nelaton catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Feb 2018to 1 Aug 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 9 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Pediatric patients scheduled for dental surgery under general anesthesia age 3-9 years
- physical status American society of Anesthesiologist(ASA) I orII
Who cannot join
- History of recurrent epistaxis
- Coagulopathy
- Previous nasal surgery
- History of nasal trauma
- Severe renal , hepatic or cardiovascular disease
- History of drug allergy to the drugs used in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Nasotracheal Tube Stenting by Nelaton Catheter in Pediatric Dental Surgery , Prospective Randomized Clinical Trial
The value of this study is to compare between stented endotracheal tube with nelaton catheter and non stented tube as regard nasotracheal related complications as epistaxis and nasal cavity injury.
- Conditions
- Anesthesia Intubation Complication
- Being tested
- Endotracheal tube, Nelaton catheter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endotracheal tubeDevice
Nasotracheal intubation will be done with endotracheal tube
Nelaton catheterDevice
Also called Stent
plus nelaton catheter
| Study group | Role | What they receive |
|---|---|---|
| Group I | Active comparator | Endotracheal tube plus Nelaton catheter Receives: Device: Endotracheal tube; Device: Nelaton catheter |
| Group II | Active comparator | Endotracheal tube Receives: Device: Endotracheal tube |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence and severity of Epistaxis
An independent anesthesiologist who did not observe the tube insertion will assess the incidence and severity of epistaxis using a laryngoscope immediately after tube passage through the nasal cavity , four grades to evaluate epistaxis 1- no epistaxis 2- mild epistaxis ,blood apparent on the surface of the tube 3-moderate epistaxis pooling of blood on the posterior pharyngeal wall 4- severe epistaxis , large amount of blood in the pharynx impeding nasotracheal intubation and necessitating urgent orotracheal intubation.
Measured: immediately after nasotracheal intubation
Secondary outcomes (1)
Histopathology of the endotracheal tube contents after extubation
after extubation the tube contents will be collected in a 5 ml syringe by using sterile swab then tissues will be separated and will be sent for histopathology , the remnant contents will be sent for microscopy , grading the contents as follow 1- secretions only 2- secretions plus blood 3- secretions , blood plus tissues .
Measured: immediately after extubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2018
- Study start10 Feb 2018
- Primary completion1 Jul 2018
- Study completion1 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anesthesia Intubation ComplicationStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- 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
- Model description
- assignment
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amin Mohammed Alansary Amin Ahmed Helwa, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03462732
- Sponsor's protocol ID
- FAMSU R 6 / 2018
- Status last verified
- May 2020
- First submitted
- 24 Feb 2018
- Last updated
- 19 May 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nasotracheal Tube Stenting by Nelaton Catheter in Pediatric Dental Surgery , Prospective Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03462732
- Acronym / sponsor ID
- FAMSU R 6 / 2018
- Conditions
- Anesthesia Intubation Complication
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 10 Feb 2018 (actual)
- Primary completion
- 1 Jul 2018 (actual)
- Study completion
- 1 Aug 2018 (actual)
- First posted
- 13 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The value of this study is to compare between stented endotracheal tube with nelaton catheter and non stented tube as regard nasotracheal related complications as epistaxis and nasal cavity injury.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- assignment
| Arm | Type | Receives |
|---|---|---|
| Group I | Active comparator | Device: Endotracheal tube, Device: Nelaton catheterEndotracheal tube plus Nelaton catheter |
| Group II | Active comparator | Device: Endotracheal tubeEndotracheal tube |
Who may qualify
- Ages
- 3 to 9 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Pediatric patients scheduled for dental surgery under general anesthesia age 3-9 years
- physical status American society of Anesthesiologist(ASA) I orII
Key exclusion criteria (6 listed)
- History of recurrent epistaxis
- Coagulopathy
- Previous nasal surgery
- History of nasal trauma
- Severe renal , hepatic or cardiovascular disease
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 |
|---|---|---|
| Endotracheal tubeNasotracheal intubation will be done with endotracheal tube | Device | Group I, Group II |
| Nelaton catheterAlso: Stentplus nelaton catheter | Device | Group I |
Primary outcome
incidence and severity of Epistaxis
Time frame: immediately after nasotracheal intubation
An independent anesthesiologist who did not observe the tube insertion will assess the incidence and severity of epistaxis using a laryngoscope immediately after tube passage through the nasal cavity , four grades to evaluate epistaxis 1- no epistaxis 2- mild epistaxis ,blood apparent on the surface of the tube 3-moderate epistaxis pooling of blood on the posterior pharyngeal wall 4- severe epistaxis , large amount of blood in the pharynx impeding nasotracheal intubation and necessitating urgent orotracheal intubation.
1 secondary outcome
Histopathology of the endotracheal tube contents after extubation
Time frame: immediately after extubation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2020.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endotracheal tube and Nelaton catheter in people with Anesthesia Intubation Complication, run by Ain Shams University at 1 site in Egypt.
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 2 inclusion and 6 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 19 May 2020. 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 Egypt. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
incidence and severity of Epistaxis (time frame: immediately after nasotracheal intubation). 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 19 May 2020.