Cardiopulmonary ArrestNCT04690517
Comparison of Tracheal Ultrasound With Capnography for Intubation Confirmation During CPR Wearing PPE
A study testing tracheal ultrasound in people with Cardiopulmonary Arrest, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
It is very important to ensure the tube placement in patients with cardiac arrest and unrecognized misplacement of endo-tracheal tube can lead to morbidity and mortality. In recent pandemic situations such as COVID-19 (Coronavirus disease-19), the number of cases of cardiopulmonary resuscitation with personal… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Cardiopulmonary Arrest
- What is being tested?
- tracheal ultrasound
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteSouth Korea
- Study dates
- 30 Jan 2021to Jul 2022
- Phase
- Interventional
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. cardiopulmonary arrest patients receiving emergency intubation and CPR
- 2. patients judged to need to wear PPE according to the judgement of the clinician
Who cannot join
- 1. sign for "do not resuscitate (DNR)"
- 2. patients unable to perform tracheal ultrasound due to trauma of the site
- 3. patients unable to perform tracheal ultrasound due to oropharynx cancer
- 4. patients unable to perform tracheal ultrasound due to placement of tracheal cannula
- 5. patients not used tracheal ultrasound for checking tube placement
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Samsung Medical Center
Seoul, 06351
Hee Yoon, Professor, 82-10-9933-5581, wildhi.yoon@samsung.com
Sooyeon Kang, fellow, 82-10-3157-4718, syrei3.kang@samsung.com
About this study
Official title: Comparison of Tracheal Ultrasound With Capnography for Intubation Confirmation During CPR (Cardiopulmonary Resuscitation) Wearing PPE (Personnel Protective Equipment): A Prospective Comparative Study
It is very important to ensure the tube placement in patients with cardiac arrest and unrecognized misplacement of endo-tracheal tube can lead to morbidity and mortality. In recent pandemic situations such as COVID-19 (Coronavirus disease-19), the number of cases of cardiopulmonary resuscitation with personal protective equipment (PPE) have increased. In those cases, existing methods such as auscultation and chest uprising have to be limited. Quantitative waveform capnography is recommended as the gold standard for confirming correct endotracheal tube placement in the 2010 American HeartAssociation (AHA) Guidelines for Cardiopulmonary resuscitation (CPR) and Emergency Cardiovascular Care (ECC), but it has some well-known limitations in cardiac arrest patients.
Ultrasonography is a non-invasive, real-time diagnostic tool commonly used during resuscitation. Especially, tracheal ultrasonography can be performed in real-time when the tube is passed through the trachea or esophagus. Previous prospective studies revealed that tracheal ultrasonography could feasibly and rapidly confirm tracheal intubation during emergency intubation.
There have already been several studies comparing the accuracy of tracheal ultrasound and capnography, but there was no study comparing the two tools under the constraints of PPE that is essential in pandemic situations as in this study. This study aimed to determine the accuracy of tracheal ultrasonography in assessing endotracheal tube position during CPR with PPE.
Read the detailed description
When patients in cardiopulmonary arrest enter a emergency room (ER) or patients staying in a ER have a cardiopulmonary arrest, participants perform intubation and CPR. When it is judged as a high-risk group with a high probability of droplet infection, all participants in resuscitation team should wear personal protective equipment. Tracheal ultrasound and end-tidal carbon dioxide are used to confirm the placement of tube. The gold standard is the direct visualization using laryngoscope. The time it takes to confirm the placement of tube is also measured.
- Conditions
- Cardiopulmonary Arrest
- Being tested
- tracheal ultrasound
- Medical subject headings
- Heart Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tracheal ultrasoundProcedure or surgery
When checking tracheal ultrasound, several signs are used in judgements. Direct signs include reverberation artifact and double ring sign. Indirect sign means checking the bilateral lung sliding.
| Study group | Role | What they receive |
|---|---|---|
| Tracheal ultrasound | Other | The patients in cardiopulmonary arrest should be performed tracheal ultrasound when tube is passed through the trachea or esophagus. Receives: Procedure: tracheal ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy
The gold standard is direct visualization using laryngoscopy. Tracheal ultrasound is performed regardless of whether it is in real-time or not.
Measured: during intubation procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2020
- Study start30 Jan 2021
- Primary completionFeb 2022 (estimated)
- Study completionJul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiopulmonary ArrestStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hee Yoon, Professor, Study chair, Samsung medical center, Emergency department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04690517
- Sponsor's protocol ID
- 2020-11-115
- Status last verified
- Dec 2020
- First submitted
- 21 Dec 2020
- Last updated
- 2 Jun 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chou HC, Chong KM, Sim SS, Ma MH, Liu SH, Chen NC, Wu MC, Fu CM, Wang CH, Lee CC, Lien WC, Chen SC. Real-time tracheal ultrasonography for confirmation of endotracheal tube placement during cardiopulmonary resuscitation. Resuscitation. 2013 Dec;84(12):1708-12. doi: 10.1016/j.resuscitation.2013.06.018. Epub 2013 Jul 9.
PubMed 23851048
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Tracheal Ultrasound With Capnography for Intubation Confirmation During CPR (Cardiopulmonary Resuscitation) Wearing PPE (Personnel Protective Equipment): A Prospective Comparative Study
- ClinicalTrials.gov ID
- NCT04690517
- Acronym / sponsor ID
- 2020-11-115
- Conditions
- Cardiopulmonary Arrest
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 30 Jan 2021 (actual)
- Primary completion
- Feb 2022 (estimated)
- Study completion
- Jul 2022 (estimated)
- First posted
- 30 Dec 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.
It is very important to ensure the tube placement in patients with cardiac arrest and unrecognized misplacement of endo-tracheal tube can lead to morbidity and mortality. In recent pandemic situations such as COVID-19 (Coronavirus disease-19), the number of cases of cardiopulmonary resuscitation with personal protective equipment (PPE) have increased. In those cases, existing methods such as auscultation and chest uprising have to be limited. Quantitative waveform capnography is recommended as the gold standard for confirming correct endotracheal tube placement in the 2010 American HeartAssociation (AHA) Guidelines for Cardiopulmonary resuscitation (CPR) and Emergency Cardiovascular Care (ECC), but it has some well-known limitations in cardiac arrest patients.
Ultrasonography is a non-invasive, real-time diagnostic tool commonly used during resuscitation. Especially, tracheal ultrasonography can be performed in real-time when the tube is passed through the trachea or esophagus. Previous prospective studies revealed that tracheal ultrasonography could feasibly and rapidly confirm tracheal intubation during emergency intubation.
There have already been several studies comparing the accuracy of tracheal ultrasound and capnography, but there was no study comparing the two tools under the constraints of PPE that is essential in pandemic situations as in this study. This study aimed to determine the accuracy of tracheal ultrasonography in assessing endotracheal tube position during CPR with PPE.
Detailed description
When patients in cardiopulmonary arrest enter a emergency room (ER) or patients staying in a ER have a cardiopulmonary arrest, participants perform intubation and CPR. When it is judged as a high-risk group with a high probability of droplet infection, all participants in resuscitation team should wear personal protective equipment. Tracheal ultrasound and end-tidal carbon dioxide are used to confirm the placement of tube. The gold standard is the direct visualization using laryngoscope. The time it takes to confirm the placement of tube is also measured.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tracheal ultrasound | Other | Procedure: tracheal ultrasoundThe patients in cardiopulmonary arrest should be performed tracheal ultrasound when tube is passed through the trachea or esophagus. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 1. cardiopulmonary arrest patients receiving emergency intubation and CPR
- 2. patients judged to need to wear PPE according to the judgement of the clinician
Key exclusion criteria (5 listed)
- 1. sign for "do not resuscitate (DNR)"
- 2. patients unable to perform tracheal ultrasound due to trauma of the site
- 3. patients unable to perform tracheal ultrasound due to oropharynx cancer
- 4. patients unable to perform tracheal ultrasound due to placement of tracheal cannula
- 5. patients not used tracheal ultrasound for checking tube placement
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 |
|---|---|---|
| tracheal ultrasoundWhen checking tracheal ultrasound, several signs are used in judgements. Direct signs include reverberation artifact and double ring sign. Indirect sign means checking the bilateral lung sliding. | Procedure or surgery | Tracheal ultrasound |
Primary outcome
Accuracy
Time frame: during intubation procedure
The gold standard is direct visualization using laryngoscopy. Tracheal ultrasound is performed regardless of whether it is in real-time or not.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2021.
- Background: PubMed 23851048Chou HC, Chong KM, Sim SS, Ma MH, Liu SH, Chen NC, Wu MC, Fu CM, Wang CH, Lee CC, Lien WC, Chen SC. Real-time tracheal ultrasonography for confirmation of endotracheal tube placement during cardiopulmonary resuscitation. Resuscitation. 2013 Dec;84(12):1708-12. doi: 10.1016/j.resuscitation.2013.06.018. Epub 2013 Jul 9.
- 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.
Hee Yoon, Professor study chair
Samsung medical center, Emergency department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tracheal ultrasound in people with Cardiopulmonary Arrest, run by Samsung Medical Center at 1 site in South Korea.
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 2 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 2 Jun 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 South Korea. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hee Yoon, Professor (+821099335581, wildhi.yoon@samsung.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy (time frame: during intubation procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04690517, which also lists 1 linked publication.
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 2 Jun 2021.