Endotracheal TubeNCT04479839
Point of Care Ultrasound to Confirm Endotracheal Tube Cuff Position in Relationship to the Cricoid in Pediatric Population.
An observational study of Endotracheal Tube and Cricoid Cartilage, run by Sidra Medicine at 1 site in Qatar.
Trial summary
Anatomically, the infra-glottic area (subglottis) and the cricoid ring are the narrowest part of the larynx. In order to limit the incidence of damage related to mucosal pressure injuries from the presence of an endotracheal tube (ETT), the cuff of the ETT should lie below the cricoid in children. Read more about this study
- Who is it for?
- Ages 1 day to 71 months
- Conditions the study is for
- Endotracheal Tube, Cricoid Cartilage, Ultrasound
- What is being tested?
- Ultrasound of the airway
- How many people
- 80 participants
- Where
- 1 siteQatar
- Study dates
- 15 Jun 2020to 10 Sep 2020
- How long will I take part?
- 3 Months
- 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 day to 71 months
- All sexes
- Child
Study population: 80 children from birth to 7 years, scheduled for the surgery requiring endotracheal intubation
Who may be able to join
- Patients undergoing general anesthesia requiring endotracheal intubation
Who cannot join
- Patients with any anatomical airway deformity or mass
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Senior Atending Anesthesiologist
Anatomically, the infra-glottic area (subglottis) and the cricoid ring are the narrowest part of the larynx. In order to limit the incidence of damage related to mucosal pressure injuries from the presence of an endotracheal tube (ETT), the cuff of the ETT should lie below the cricoid in children. Previously, no clinical or imaging method has been used in real time at the bedside to determine the exact location of the ETT cuff after endotracheal intubation. Point-of-care ultrasound (POCUS) may provide an option for a safe and rapid means of visualizing the cuff of the ETT and its relationship to the cricoid ring in real-time thereby allowing ideal ETT positioning.
Read the detailed description
Airway below vocal cords until the distal end of the cricoid referred to as subglottis or infraglottis is considered to be the narrowest part of the airway. An optimal endotracheal tube (ETT) placement with cuffed ETT is to ensure the cuff position below the cricoid ring (cuff free glottis): as well have sufficient distance between ETT tip and carina. Various modalities including clinical examination, ETCO2, imaging (X-ray and ultrasound) are routinely used to verify the position and the tip of the ETT in the airway, however verification of the cuff position remains obscure.
- Conditions
- Endotracheal Tube, Cricoid Cartilage, Ultrasound
- Being tested
- Ultrasound of the airway
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound of the airwayDiagnostic test
Placing ultrasound on the neck after intubation
| Study group | Role | What they receive |
|---|---|---|
| Microcuff ETT | Patients intubated with microcuff ETT Receives: Diagnostic Test: Ultrasound of the airway | |
| Non-microcuff ett | Patients intubated with regular ETT Receives: Diagnostic Test: Ultrasound of the airway |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visualize the saline-filled cuff of the endotracheal tube
The primary objective was to visualize the saline-filled cuff of the endotracheal tube in relation to the cricoid and tracheal rings
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2020
- Study start15 Jun 2020
- Primary completion10 Sep 2020
- Study completion10 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endotracheal TubeStudies 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
- 80 participants (actual)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Sidra Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tariq Wani, Sidra Medicine
- Investigators
- Tariq Wani, Principal investigator, Attending physician
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04479839
- Sponsor's protocol ID
- 1570971
- Status last verified
- Jul 2021
- First submitted
- 16 Jul 2020
- Last updated
- 9 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Senior Atending Anesthesiologist
- ClinicalTrials.gov ID
- NCT04479839
- Acronym / sponsor ID
- 1570971
- Conditions
- Endotracheal Tube, Cricoid Cartilage, Ultrasound
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Sidra MedicineUniversity, hospital or other
- Study start
- 15 Jun 2020 (actual)
- Primary completion
- 10 Sep 2020 (actual)
- Study completion
- 10 Sep 2020 (actual)
- First posted
- 21 Jul 2020 (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.
Anatomically, the infra-glottic area (subglottis) and the cricoid ring are the narrowest part of the larynx. In order to limit the incidence of damage related to mucosal pressure injuries from the presence of an endotracheal tube (ETT), the cuff of the ETT should lie below the cricoid in children. Previously, no clinical or imaging method has been used in real time at the bedside to determine the exact location of the ETT cuff after endotracheal intubation. Point-of-care ultrasound (POCUS) may provide an option for a safe and rapid means of visualizing the cuff of the ETT and its relationship to the cricoid ring in real-time thereby allowing ideal ETT positioning.
Detailed description
Airway below vocal cords until the distal end of the cricoid referred to as subglottis or infraglottis is considered to be the narrowest part of the airway. An optimal endotracheal tube (ETT) placement with cuffed ETT is to ensure the cuff position below the cricoid ring (cuff free glottis): as well have sufficient distance between ETT tip and carina. Various modalities including clinical examination, ETCO2, imaging (X-ray and ultrasound) are routinely used to verify the position and the tip of the ETT in the airway, however verification of the cuff position remains obscure.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Microcuff ETT | – | Diagnostic Test: Ultrasound of the airwayPatients intubated with microcuff ETT |
| Non-microcuff ett | – | Diagnostic Test: Ultrasound of the airwayPatients intubated with regular ETT |
Who may qualify
- Ages
- 1 day to 71 months
- Sex
- All
- Age groups
- Child
- Study population
- 80 children from birth to 7 years, scheduled for the surgery requiring endotracheal intubation
Key inclusion criteria (1 listed)
- Patients undergoing general anesthesia requiring endotracheal intubation
Key exclusion criteria (1 listed)
- Patients with any anatomical airway deformity or mass
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 |
|---|---|---|
| Ultrasound of the airwayPlacing ultrasound on the neck after intubation | Diagnostic test | Microcuff ETT, Non-microcuff ett |
Primary outcome
Visualize the saline-filled cuff of the endotracheal tube
Time frame: 3 months
The primary objective was to visualize the saline-filled cuff of the endotracheal tube in relation to the cricoid and tracheal rings
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 9 Jul 2021.
- Individual participant dataSharing planned: No
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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.
Tariq Wani principal investigator
Attending physician
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 Endotracheal Tube and Cricoid Cartilage, run by Sidra Medicine at 1 site in Qatar.
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: finished, as of the sponsor's last update on 9 Jul 2021. 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 Qatar. 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?
Visualize the saline-filled cuff of the endotracheal tube (time frame: 3 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 Jul 2021.