D009863NCT03388710
Position of the Endotracheal Tube Cuff in Relation to Cricoid in Children.
An observational study of D009863, run by King Fahad Medical City at 1 site in Saudi Arabia.
Trial summary
To verify the exact location of cuff of the endotracheal tube in children. Read more about this study
- Who is it for?
- Ages 1 month to 8 years
- Conditions the study is for
- D009863
- What is being tested?
- XRay
- Type of treatment
- Surgery or procedure
- How many people
- 20 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 1 Nov 2017to 30 Jun 2019
- Phase
- Observational
- 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 1 month to 8 years
- All sexes
- No healthy volunteers
- Child
Study population: Children for any surgical procedure requiring endotracheal intubation
Who may be able to join
- Children aged 1 month to 8 years
Who cannot join
- Any airway pathology
Trial locations and contacts
1 site in 1 country.
Saudi Arabia1 site, 1 recruiting
- Recruiting
King Fahad Medical City
Riyadh, 11525
Tariq Wani, MD, +966539417828, twani1@kfmc.med.sa
About this study
Official title: Consultant Anesthesiology
To verify the exact location of cuff of the endotracheal tube in children.
Read the detailed description
The exact location of the cuff of the endotracheal tube in children has not been studied. This study is the first attempt to verify the position of the cuff in the airway with relation to cricoid.
- Conditions
- D009863
- Being tested
- XRay
- Keywords
- airway, children, endotracheal tube, cuff
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XRayRadiation
Xray to confirm the location of the endotracheal tube
What is being measured
The primary outcome is the main question the study is designed to answer.
Cuff position
Location of the cuff of the ETT
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2018
- Study start1 Nov 2017
- Primary completion30 Jun 2019 (estimated)
- Study completion30 Jun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for D009863Studies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King Fahad Medical City
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Tariq Wani, King Fahad Medical City
- Investigators
- Tariq Wani, MD, Principal investigator, Consultant
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03388710
- Sponsor's protocol ID
- KFMC
- Status last verified
- Apr 2019
- First submitted
- 25 Dec 2017
- Last updated
- 9 Apr 2019
- Results posted
- No
- Data monitoring committee
- 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 9 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Consultant Anesthesiology
- ClinicalTrials.gov ID
- NCT03388710
- Acronym / sponsor ID
- KFMC
- Conditions
- D009863
- Keywords
- airway, children, endotracheal tube, cuff
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- King Fahad Medical CityOther government
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- 30 Jun 2019 (estimated)
- Study completion
- 30 Jun 2019 (estimated)
- First posted
- 3 Jan 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.
To verify the exact location of cuff of the endotracheal tube in children.
Detailed description
The exact location of the cuff of the endotracheal tube in children has not been studied. This study is the first attempt to verify the position of the cuff in the airway with relation to cricoid.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 month to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children for any surgical procedure requiring endotracheal intubation
Key inclusion criteria (1 listed)
- Children aged 1 month to 8 years
Key exclusion criteria (1 listed)
- Any airway pathology
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 |
|---|---|---|
| XRayXray to confirm the location of the endotracheal tube | Radiation | – |
Primary outcome
Cuff position
Time frame: 6 months
Location of the cuff of the ETT
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2019.
- Individual participant dataSharing planned: Undecided
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.
Tariq Wani, MD principal investigator
Consultant
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of D009863, run by King Fahad Medical City at 1 site in Saudi Arabia.
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 1 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: status not confirmed, as of the sponsor's last update on 9 Apr 2019. 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 Saudi Arabia. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tariq Wani, MD (966539417828, tariqwani@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cuff position (time frame: 6 months). 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 9 Apr 2019.