Endotracheal Tube Wrongly Placed During Anesthetic ProcedureNCT01373437
Ultrasonography in Confirming Proper Position of Endotracheal Tube
An observational study of Endotracheal Tube Wrongly Placed During Anesthetic Procedure, run by Mahidol University at 1 site in Thailand.
Trial summary
The purpose of this study is to assess the applicability of using ultrasonography in confirmation of the position of the endotracheal tube (ETT) after intubated to patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Endotracheal Tube Wrongly Placed During Anesthetic Procedure
- What is being tested?
- Ultrasonography (Sonosite )
- Type of treatment
- Medical device
- How many people
- 80 participants
- Where
- 1 siteThailand
- Study dates
- Sep 2010to Dec 2010
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The patients who visited the emergency department, Siriraj hospital and needed ETT intubation as their adequate treatment. In the period from September 2010 to November 2010.
Who may be able to join
- age >18 years old with either endotracheal or nasotracheal intubation
- having normal airway anatomy
- performed portable CXR after intubation
Who cannot join
- presence in history of neck radiation, cervical spine immobility/instability
- unstable vital signs
- unwilling to participate or denial of informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ultrasonography in Confirming Proper Position of Endotracheal Tube in Emergency Department at Siriraj Hospital: Applicability and Accuracy
The purpose of this study is to assess the applicability of using ultrasonography in confirmation of the position of the endotracheal tube (ETT) after intubated to patients.
Read the detailed description
To assess the applicability of using ultrasonography as compared to routine portable CXR in confirmation of ETT position.
To determine the accuracy of ultrasonography in measuring the depth of ETT as compare to standard CXR method.
- Being tested
- Ultrasonography (Sonosite )
- Keywords
- Ultrasonography, US, Confirming, Confirmation, Proper, Position, Endotracheal tube, ETT, Emergency department, ED, Applicability, Accuracy
- Medical subject headings
- Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasonography (Sonosite )Device
Sonosite MICROMAXXTM with linear probe L38e/10-5 MHz
| Study group | Role | What they receive |
|---|---|---|
| Intubate | Not described Receives: Device: Ultrasonography (Sonosite ) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The confirmation of ETT depth
A transcricothyroid membrane view of the ultrasonography was chosen for confirmation of ETT depth measurement. Firstly, measured the distance from probe (skin) to anterior surface of ETT. Then, measured the distance from probe (skin) to balloon cuff level. Finally the depth of ETT (Distance from vocal cord to balloon cuff) was calculated by using Pythagorus rule.
Measured: 1 hour
Secondary outcomes (1)
The confirming the presence of ETT in airway.
A transcricothyroid membrane view was chosen for confirmation of ETT position. Various glottic structures such as True Vocal Cord (TVC), False Vocal Cord (FVC), and arythenoid cartilage can be visualized.
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2011 (estimated)
- Study startSep 2010
- Primary completionDec 2010
- Study completionDec 2010
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 Mahidol 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Investigators
- Phuriphong Songarj, MD, Study director, Faculty of Medicine Siriraj Hospital, Mahidol University, Thailand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01373437
- Sponsor's protocol ID
- 345/2553(EC4)
- Status last verified
- Jun 2011
- First submitted
- 9 Jun 2011
- Last updated
- 15 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasonography in Confirming Proper Position of Endotracheal Tube in Emergency Department at Siriraj Hospital: Applicability and Accuracy
- ClinicalTrials.gov ID
- NCT01373437
- Acronym / sponsor ID
- 345/2553(EC4)
- Keywords
- Ultrasonography, US, Confirming, Confirmation, Proper, Position, Endotracheal tube, ETT
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 15 Jun 2011 (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.
The purpose of this study is to assess the applicability of using ultrasonography in confirmation of the position of the endotracheal tube (ETT) after intubated to patients.
Detailed description
To assess the applicability of using ultrasonography as compared to routine portable CXR in confirmation of ETT position.
To determine the accuracy of ultrasonography in measuring the depth of ETT as compare to standard CXR method.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intubate | – | Device: Ultrasonography (Sonosite ) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The patients who visited the emergency department, Siriraj hospital and needed ETT intubation as their adequate treatment. In the period from September 2010 to November 2010.
Key inclusion criteria (3 listed)
- age >18 years old with either endotracheal or nasotracheal intubation
- having normal airway anatomy
- performed portable CXR after intubation
Key exclusion criteria (3 listed)
- presence in history of neck radiation, cervical spine immobility/instability
- unstable vital signs
- unwilling to participate or denial of informed consent
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 |
|---|---|---|
| Ultrasonography (Sonosite )Sonosite MICROMAXXTM with linear probe L38e/10-5 MHz | Device | Intubate |
Primary outcome
The confirmation of ETT depth
Time frame: 1 hour
A transcricothyroid membrane view of the ultrasonography was chosen for confirmation of ETT depth measurement. Firstly, measured the distance from probe (skin) to anterior surface of ETT. Then, measured the distance from probe (skin) to balloon cuff level. Finally the depth of ETT (Distance from vocal cord to balloon cuff) was calculated by using Pythagorus rule.
1 secondary outcome
The confirming the presence of ETT in airway.
Time frame: 1 hour
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 Jun 2011.
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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.
Phuriphong Songarj, MD study director
Faculty of Medicine Siriraj Hospital, Mahidol University, Thailand
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 Wrongly Placed During Anesthetic Procedure, run by Mahidol University at 1 site in Thailand.
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 3 inclusion and 3 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 Jun 2011. 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 Thailand. 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?
The confirmation of ETT depth (time frame: 1 hour). 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 Jun 2011.