Endotracheal Tube Wrongly Placed During Anesthetic ProcedurePOCUSNCT03031548
Intra-op POCUS for Identification of Endotracheal Tube Position in the Pediatric Population
An observational study of Endotracheal Tube Wrongly Placed During Anesthetic Procedure, run by Loma Linda University at 2 sites in United States.
Trial summary
Chest X-ray and/or fluoroscopy is not routinely used in the OR to confirm endotracheal tube (ETT) placement by anesthesiologists. Multiple studies have shown that ~19% of all intubations result in inappropriate ETT placement. Read more about this study
- Who is it for?
- Ages 1 minute to 10 years
- Conditions the study is for
- Endotracheal Tube Wrongly Placed During Anesthetic Procedure
- What is being tested?
- Point-of-care ultrasound exam and Reposition ETT
- Type of treatment
- Medical device, Surgery or procedure
- How many people
- 50 participants
- Where
- 2 sitesUnited States
- Study dates
- 16 Feb 2017to 30 Jun 2018
- 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 minute to 10 years
- All sexes
- No healthy volunteers
- Child
Study population: Children who require general anesthesia and endotracheal intubation for procedures in the cardiovascular laboratory
Who may be able to join
- children birth to 10 years of age;
- undergoing cardiac catheterization in the cath lab;
- general anesthesia with an endotracheal tube;
- subjects will also receive a chest x-ray as standard of care
Who cannot join
- children ages birth to 10 years undergoing cardiac catheterization under GA without an endotracheal tube;
- emergency procedures;
- known airway anomalies;
- children who are non-English and non-Spanish speaking -
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Loma Linda University Health
Loma Linda, California, 92350
Loma Linda University Department of Anesthesiology
Loma Linda, California, 92354
About this study
Official title: Intraoperative Point-of Care Ultrasound for Identification of Endotracheal Tube Position in the Pediatric Population
Chest X-ray and/or fluoroscopy is not routinely used in the OR to confirm endotracheal tube (ETT) placement by anesthesiologists. Multiple studies have shown that ~19% of all intubations result in inappropriate ETT placement. An adult study has shown that ultrasound point-of-care is superior to auscultation in determining the location of ETT. This study aims to determine if point-of-care is useful in determining ETT position in children.
Read the detailed description
Patients scheduled to have a procedure in the cardiovascular laboratory where fluoroscopy is routinely used will also undergo a point-of-care ultrasound exam to determine endotracheal tube position. An anesthesiologist will perform the ultrasound exam.
- Being tested
- Point-of-care ultrasound exam, Reposition ETT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Point-of-care ultrasound examDevice
Also called POC ultrasound
No intervention
Reposition ETTRadiation
ETT will be repositioned based on CXR by fluoroscopy
| Study group | Role | What they receive |
|---|---|---|
| ultrasound exam | Child undergoing procedure in CVL requiring ETT and CXR as standard of care - received point-of-care ultrasound exam as part of the study Receives: Device: Point-of-care ultrasound exam; Radiation: Reposition ETT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endotracheal Tube Position
The primary outcome marker for this study was the correlation between the weighted POCUS measurement of TT location and the weighted fluoroscopy measurement of TT location
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2017 (estimated)
- Study start16 Feb 2017
- Primary completion30 Jun 2018
- Study completion30 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endotracheal Tube Wrongly Placed During Anesthetic ProcedureStudies of the same condition, open and under way.
- More trials run by Loma Linda 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Loma Linda University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elizabeth Ghazal, Loma Linda University
- Investigators
- Elizabeth Ghazal, MD, Principal investigator, Loma Linda University Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03031548
- Sponsor's protocol ID
- 5160372
- Acronym
- POCUS
- Status last verified
- Mar 2021
- First submitted
- 9 Jan 2017
- Last updated
- 15 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- 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 15 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraoperative Point-of Care Ultrasound for Identification of Endotracheal Tube Position in the Pediatric Population
- ClinicalTrials.gov ID
- NCT03031548
- Acronym / sponsor ID
- POCUS / 5160372
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Loma Linda UniversityUniversity, hospital or other
- Study start
- 16 Feb 2017 (actual)
- Primary completion
- 30 Jun 2018 (actual)
- Study completion
- 30 Jun 2018 (actual)
- First posted
- 25 Jan 2017 (estimated)
- 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.
Chest X-ray and/or fluoroscopy is not routinely used in the OR to confirm endotracheal tube (ETT) placement by anesthesiologists. Multiple studies have shown that ~19% of all intubations result in inappropriate ETT placement. An adult study has shown that ultrasound point-of-care is superior to auscultation in determining the location of ETT. This study aims to determine if point-of-care is useful in determining ETT position in children.
Detailed description
Patients scheduled to have a procedure in the cardiovascular laboratory where fluoroscopy is routinely used will also undergo a point-of-care ultrasound exam to determine endotracheal tube position. An anesthesiologist will perform the ultrasound exam.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ultrasound exam | – | Device: Point-of-care ultrasound exam, Radiation: Reposition ETTChild undergoing procedure in CVL requiring ETT and CXR as standard of care - received point-of-care ultrasound exam as part of the study |
Who may qualify
- Ages
- 1 minute to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children who require general anesthesia and endotracheal intubation for procedures in the cardiovascular laboratory
Key inclusion criteria (4 listed)
- children birth to 10 years of age;
- undergoing cardiac catheterization in the cath lab;
- general anesthesia with an endotracheal tube;
- subjects will also receive a chest x-ray as standard of care
Key exclusion criteria (4 listed)
- children ages birth to 10 years undergoing cardiac catheterization under GA without an endotracheal tube;
- emergency procedures;
- known airway anomalies;
- children who are non-English and non-Spanish speaking -
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 |
|---|---|---|
| Point-of-care ultrasound examAlso: POC ultrasoundNo intervention | Device | ultrasound exam |
| Reposition ETTETT will be repositioned based on CXR by fluoroscopy | Radiation | ultrasound exam |
Primary outcome
Endotracheal Tube Position
Time frame: through study completion, an average of 1 year
The primary outcome marker for this study was the correlation between the weighted POCUS measurement of TT location and the weighted fluoroscopy measurement of TT location
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 15 Mar 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.
Elizabeth Ghazal, MD principal investigator
Loma Linda University Health
2 sites 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 Wrongly Placed During Anesthetic Procedure, run by Loma Linda University at 2 sites 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 4 inclusion and 4 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 15 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
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?
Endotracheal Tube Position (time frame: through study completion, an average of 1 year). 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 15 Mar 2021.