Intubation, IntratrachealNCT01227486
Verification of Endotracheal Tube Placement by Ultrasound in the Obese Patient
An observational study of Intubation, Intratracheal and Obesity, run by Bispebjerg Hospital at 1 site in Denmark.
Trial summary
The purpose of this study is to determine whether verification of correct tube placement after endotracheal intubation in the obese patient can be conducted as fast with ultrasound as with the conventional method of combined auscultation and capnography. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intubation, Intratracheal, Obesity
- What is being tested?
- Ultrasound
- Type of treatment
- Medical device
- How many people
- 24 participants
- Where
- 1 siteDenmark
- Study dates
- Oct 2010to not given
- 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: Obese patients admitted for planned bariatric surgery on Glostrup Hospital, Denmark
Who may be able to join
- Planned for bariatric surgery in general anaesthesia
- Planned for endotracheal intubation
- BMI above 30
Who cannot join
- Predicted difficult airway in the pre-anaesthesia airway evaluation.
- Unpredicted difficult airway during induction of anaesthesia where assistance is needed by the investigators.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Anaesthesiology, Bariatric section. Copenhagen University Hospital Glostrup
Glostrup Municipality, DK-2600
About this study
The purpose of this study is to determine whether verification of correct tube placement after endotracheal intubation in the obese patient can be conducted as fast with ultrasound as with the conventional method of combined auscultation and capnography.
The investigators hypothesize that ultrasound is a faster method for verifying correct endotracheal tube placement in the obese patient than combined auscultation and capnography.
Read the detailed description
Both verification methods are conducted in all patients and patients act as their own control
- Conditions
- Intubation, Intratracheal, Obesity
- Being tested
- Ultrasound
- Keywords
- Intubation, intratracheal, Ultrasonography, Auscultation, Capnography, Obesity
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UltrasoundDevice
Ultrasound scan just proximal to the suprasternal notch during intubation and ultrasound scan of both lungs during ventilation
| Study group | Role | What they receive |
|---|---|---|
| Obese patients for planned surgery and endotracheal intubation | Not described Receives: Device: Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in time to correct verification of endotracheal tube placement between ultrasound and combined auscultation and capnography
Measured: 0 to 1 hour
Secondary outcomes (1)
Difference in time to correct verification of endotracheal tube placement between ultrasound and auscultation alone
Measured: 0 to 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2010 (estimated)
- Study startOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intubation, IntratrachealStudies 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
- Time perspective
- Prospective
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bispebjerg Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Dan Isbye, M.D., PhD., Principal investigator, Department of Anaesthesiology, Copenhagen University Hospital Bispbjerg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01227486
- Sponsor's protocol ID
- disb-01-10
- Status last verified
- Nov 2010
- First submitted
- 20 Oct 2010
- Last updated
- 24 Nov 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Verification of Endotracheal Tube Placement by Ultrasound in the Obese Patient
- ClinicalTrials.gov ID
- NCT01227486
- Acronym / sponsor ID
- disb-01-10
- Conditions
- Intubation, Intratracheal, Obesity
- Keywords
- Intubation, intratracheal, Ultrasonography, Auscultation, Capnography, Obesity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Bispebjerg HospitalUniversity, hospital or other
- Study start
- Oct 2010
- First posted
- 25 Oct 2010 (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 determine whether verification of correct tube placement after endotracheal intubation in the obese patient can be conducted as fast with ultrasound as with the conventional method of combined auscultation and capnography.
The investigators hypothesize that ultrasound is a faster method for verifying correct endotracheal tube placement in the obese patient than combined auscultation and capnography.
Detailed description
Both verification methods are conducted in all patients and patients act as their own control
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Obese patients for planned surgery and endotracheal intubation | – | Device: Ultrasound |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Obese patients admitted for planned bariatric surgery on Glostrup Hospital, Denmark
Key inclusion criteria (3 listed)
- Planned for bariatric surgery in general anaesthesia
- Planned for endotracheal intubation
- BMI above 30
Key exclusion criteria (2 listed)
- Predicted difficult airway in the pre-anaesthesia airway evaluation.
- Unpredicted difficult airway during induction of anaesthesia where assistance is needed by the investigators.
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 |
|---|---|---|
| UltrasoundUltrasound scan just proximal to the suprasternal notch during intubation and ultrasound scan of both lungs during ventilation | Device | Obese patients for planned surgery and endotracheal intubation |
Primary outcome
Difference in time to correct verification of endotracheal tube placement between ultrasound and combined auscultation and capnography
Time frame: 0 to 1 hour
1 secondary outcome
Difference in time to correct verification of endotracheal tube placement between ultrasound and auscultation alone
Time frame: 0 to 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 24 Nov 2010.
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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.
Dan Isbye, M.D., PhD. principal investigator
Department of Anaesthesiology, Copenhagen University Hospital Bispbjerg
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, Intratracheal and Obesity, run by Bispebjerg Hospital at 1 site in Denmark.
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 2 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 24 Nov 2010. 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 Denmark. 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?
Difference in time to correct verification of endotracheal tube placement between ultrasound and combined auscultation and capnography (time frame: 0 to 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 24 Nov 2010.