IntubationNCT03081221
Verification of Endotracheal Tube Placement With Ultrasonography (USG)
An observational study of Intubation, run by Cukurova University at 1 site in Turkey (Türkiye).
Trial summary
The purpose of this study is to verification of Endotracheal Tube Placement with Ultrasonography (USG). Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Intubation
- What is being tested?
- USG
- How many people
- 64 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jun 2016to Jul 2018
- How long will I take part?
- 1 Day
- 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 Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: 0-18 age children
Who may be able to join
- applied intubation patients
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Verification of Endotracheal Tube Placement With Ultrasonography (USG) in Patients
The purpose of this study is to verification of Endotracheal Tube Placement with Ultrasonography (USG).
Read the detailed description
The purpose of this study is to verification of Endotracheal Tube Placement with Ultrasonography (USG). In this study, using of USG during verification will be compared with traditional method.
In traditional methods, after intubation, verification of endotracheal tube placement is done via to monitoring of thorax movement, checking of tube fogging, auscultation of lung and stomach, capnography and radiography.
In USG method, after intubation, verification of endotracheal tube placement is done via to using linear transducer. The probe will be placed transversely and longitudinally on the neck and in front of cricoid cartilage.
So, collected all data from two method will be compared.
- Conditions
- Intubation
- Being tested
- USG
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
USGDiagnostic test
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection of Tube
Tube shall be detected with Ultrasonography (USG)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2017
- Study startJun 2016
- Primary completionJun 2017
- Study completionJul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IntubationStudies of the same condition, open and under way.
- More trials run by Cukurova 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
- Cross-sectional
- Enrolment
- 64 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Cukurova University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ozlem Tolu Kendir, Cukurova University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03081221
- Sponsor's protocol ID
- 60-68
- Status last verified
- Feb 2019
- First submitted
- 10 Mar 2017
- Last updated
- 4 Feb 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 4 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Verification of Endotracheal Tube Placement With Ultrasonography (USG) in Patients
- ClinicalTrials.gov ID
- NCT03081221
- Acronym / sponsor ID
- 60-68
- Conditions
- Intubation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Cukurova UniversityUniversity, hospital or other
- Study start
- Jun 2016 (actual)
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jul 2018 (actual)
- First posted
- 16 Mar 2017 (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 purpose of this study is to verification of Endotracheal Tube Placement with Ultrasonography (USG).
Detailed description
The purpose of this study is to verification of Endotracheal Tube Placement with Ultrasonography (USG). In this study, using of USG during verification will be compared with traditional method.
In traditional methods, after intubation, verification of endotracheal tube placement is done via to monitoring of thorax movement, checking of tube fogging, auscultation of lung and stomach, capnography and radiography.
In USG method, after intubation, verification of endotracheal tube placement is done via to using linear transducer. The probe will be placed transversely and longitudinally on the neck and in front of cricoid cartilage.
So, collected all data from two method will be compared.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- 0-18 age children
Key inclusion criteria (1 listed)
- applied intubation patients
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| USG | Diagnostic test | – |
Primary outcome
Detection of Tube
Time frame: 1 year
Tube shall be detected with Ultrasonography (USG)
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 4 Feb 2019.
- 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?
An observational study of Intubation, run by Cukurova University at 1 site in Turkey (Türkiye).
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 4 Feb 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 Turkey (Türkiye). 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?
Detection of Tube (time frame: 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 4 Feb 2019.