Intubation, IntratrachealNCT06542406
Can Endotracheal Tube Fluctuation With Epigastric Compression Be Used as a Confirmation Method for Endotracheal Intubation?
A study testing Endotracheal intubation in people with Intubation, Intratracheal, run by Duzce University at 1 site in Turkey (Türkiye).
Trial summary
Endotracheal intubation (ETE) may also need to be performed outside the hospital as advanced airway management. In such cases, facilities such as imaging methods, ultrasound or capnography may not be available and only traditional methods such as auscultation of lung sounds, auscultation of the epigastric region… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intubation, Intratracheal
- What is being tested?
- Endotracheal intubation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 18 Feb 2021to 4 Mar 2023
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Older than 18 years of age
- Underwent ETE outside the hospital or within the first hour of arrival to the emergency department
Who cannot join
- Patients in whom ETE was previously confirmed by USG or PETCO2,
- Patients intubated at external centers
- Patients who had known airway stenosis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Can the Fluctuation Observed in the Endotracheal Tube With Compression Applied to the Epigastric Region be Used as a Confirmation Method for Endotracheal Intubation?
Endotracheal intubation (ETE) may also need to be performed outside the hospital as advanced airway management. In such cases, facilities such as imaging methods, ultrasound or capnography may not be available and only traditional methods such as auscultation of lung sounds, auscultation of the epigastric region without hearing airflow, observation of chest expansion after ventilation, observation of water vapor in the tube may have to be used. Despite all these observational methods and equipment used, it is recommended to keep in mind that there may be errors and to try to provide confirmation with more than one method.
Especially in disaster situations where technological infrastructure is not available and sometimes outside the hospital, the use of traditional methods based on examination may be of vital importance. The traditional methods mentioned above are mostly used to detect tracheal localization and to exclude esophageal localization. In our observations in patients with cardiopulmonary arrest, the investigators noticed that in the case of esophageal placement of the tube, manual compression of the epigastric region produced a fluctuation in the tube and valved balloon caused by airflow. The investigators thought that this could be a method to confirm esophageal placement. The aim of this study was to investigate the usefulness of epigastric manual compression in the confirmation of esophageal placement of the tube.
Read the detailed description
Patients who underwent ETE outside the hospital or in the first hour of arrival to the emergency department were evaluated after the procedure. Out-of-hospital ETE was performed by experienced paramedics working in the emergency ambulance service, and ETE in the emergency department was performed by emergency medicine residents or emergency medicine specialists with at least 2 years of emergency department experience. Out-of-hospital procedures were performed at the first visit to the emergency department, and procedures performed in the emergency department were confirmed by ETE immediately after the procedure.
Confirmation was performed single-blind by emergency medicine specialists with at least 5 years of experience, without knowing who performed the procedure and where (in or out of the hospital). Confirmation was performed by auscultation of lung sounds (from the anterior and lateral sides of both lungs, upper and lower zones), evaluation of equal participation of both thoraxes in breathing by inspection, auscultation of the epigastric region, placement of capnography, monitoring of water vapor in the tube, manual compression of the epigastric region at least three times and evaluation of fluctuation in the tube, and pulse oximetry monitoring.
Epigastric compression was performed by applying pressure to the epigastric region at least three times with the volar side of the intubated patient while the patient was ventilated with a balloon-valved mask. During this procedure, the fluctuation of the air and fluid in the stomach inside the esophageal tube can be observed and its sound can be heard. It can be applied from the first inhalation.
The ultrasonography (USG) procedure was evaluated by placing a linear ultrasound probe [SonoSite M-Turbo linear probe (13-6 MHz), Sonosite, Inc, Bothell, WA, USA] in the transverse position on the anterior side of the neck, just above the suprasternal notch, and observing the position of the tube (presence of a double path sign) and pleural sliding movement. While a single semicircular echogenic area is observed when the tube is in the trachea, a second semicircular echogenic area is observed when the tube is located in the esophagus. USG was performed immediately after the ETE procedure. In patients in whom double pathway sign was observed and pleural sliding motion was not observed, the patient was re-intubated by the experienced specialist performing USG. It was confirmed by USG again. These procedures were categorized as "failed".
partial endtidal carbon dioxide (PETCO2) measurement by capnography was performed using a mainstream EMMA® Capnograph (PHASEIN AB Svärdvägen, Danderyd, Sweden) for intubated patients. It was assessed by the detection of PETCO2 greater than 5 mmHg after five breaths and the appearance of a typical square waveform.
- Conditions
- Intubation, Intratracheal
- Being tested
- Endotracheal intubation
- Keywords
- endotracheal intubation, esophageal placement, epigastric fluctuation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endotracheal intubationDevice
The first 40 successful and the first 40 unsuccessful ETE procedures were included in the study.
| Study group | Role | What they receive |
|---|---|---|
| Endotracheal intubation | Other | Patients admitted to the emergency department between 01/05/2021 and 30/05/2022, who were older than 18 years of age and who underwent ETE outside the hospital or within the first hour of arrival to the emergency department were included in the study. Receives: Device: Endotracheal intubation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Confirmation with ultrasonography: Successful or Failed
Fluctuation with Epigastric Compression: Yes or No
Failed Successful Failed
Measured: 13 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2024
- Study start18 Feb 2021
- Primary completion4 Mar 2023
- Study completion4 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duzce University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, kudret selki, Duzce University
- Investigators
- Mustafa Boğan, MD, Study director, Duzce University, School of Medicine, Emergency Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06542406
- Sponsor's protocol ID
- DuzceUniversityEM
- Status last verified
- Aug 2024
- First submitted
- 26 Jul 2024
- Last updated
- 7 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data can be shared with those who request it.
Publications
Farrokhi M, Yarmohammadi B, Mangouri A, Hekmatnia Y, Bahramvand Y, Kiani M, Nasrollahi E, Nazari-Sabet M, Manoochehri-Arash N, Khurshid M, Mosalanejad S, Hajizadeh V, Amani-Beni R, Moallem M, Farahmandsadr M. Screening Performance Characteristics of Ultrasonography in Confirmation of Endotracheal Intubation; a Systematic Review and Meta-analysis. Arch Acad Emerg Med. 2021 Oct 26;9(1):e68. doi: 10.22037/aaem.v9i1.1360. eCollection 2021.
PubMed 34870234Li X, Zhang J, Karunakaran M, Hariharan VS. Diagnostic accuracy of ultrasonography for the confirmation of endotracheal tube intubation: a systematic review and meta-analysis. Med Ultrason. 2023 Mar 30;25(1):72-81. doi: 10.11152/mu-3594. Epub 2022 Jun 3.
PubMed 36780595Kramer-Johansen J, Dorph E, Steen PA. Detection of carbon dioxide in expired air after oesophageal intubation; the role of bystander mouth-to-mouth ventilation. Acta Anaesthesiol Scand. 2008 Jan;52(1):155-7. doi: 10.1111/j.1399-6576.2007.01503.x. Epub 2007 Nov 12.
PubMed 17999713
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can the Fluctuation Observed in the Endotracheal Tube With Compression Applied to the Epigastric Region be Used as a Confirmation Method for Endotracheal Intubation?
- ClinicalTrials.gov ID
- NCT06542406
- Acronym / sponsor ID
- DuzceUniversityEM
- Conditions
- Intubation, Intratracheal
- Keywords
- endotracheal intubation, esophageal placement, epigastric fluctuation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Duzce UniversityUniversity, hospital or other
- Study start
- 18 Feb 2021 (actual)
- Primary completion
- 4 Mar 2023 (actual)
- Study completion
- 4 Mar 2023 (actual)
- First posted
- 7 Aug 2024 (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.
Endotracheal intubation (ETE) may also need to be performed outside the hospital as advanced airway management. In such cases, facilities such as imaging methods, ultrasound or capnography may not be available and only traditional methods such as auscultation of lung sounds, auscultation of the epigastric region without hearing airflow, observation of chest expansion after ventilation, observation of water vapor in the tube may have to be used. Despite all these observational methods and equipment used, it is recommended to keep in mind that there may be errors and to try to provide confirmation with more than one method.
Especially in disaster situations where technological infrastructure is not available and sometimes outside the hospital, the use of traditional methods based on examination may be of vital importance. The traditional methods mentioned above are mostly used to detect tracheal localization and to exclude esophageal localization. In our observations in patients with cardiopulmonary arrest, the investigators noticed that in the case of esophageal placement of the tube, manual compression of the epigastric region produced a fluctuation in the tube and valved balloon caused by airflow. The investigators thought that this could be a method to confirm esophageal placement. The aim of this study was to investigate the usefulness of epigastric manual compression in the confirmation of esophageal placement of the tube.
Detailed description
Patients who underwent ETE outside the hospital or in the first hour of arrival to the emergency department were evaluated after the procedure. Out-of-hospital ETE was performed by experienced paramedics working in the emergency ambulance service, and ETE in the emergency department was performed by emergency medicine residents or emergency medicine specialists with at least 2 years of emergency department experience. Out-of-hospital procedures were performed at the first visit to the emergency department, and procedures performed in the emergency department were confirmed by ETE immediately after the procedure.
Confirmation was performed single-blind by emergency medicine specialists with at least 5 years of experience, without knowing who performed the procedure and where (in or out of the hospital). Confirmation was performed by auscultation of lung sounds (from the anterior and lateral sides of both lungs, upper and lower zones), evaluation of equal participation of both thoraxes in breathing by inspection, auscultation of the epigastric region, placement of capnography, monitoring of water vapor in the tube, manual compression of the epigastric region at least three times and evaluation of fluctuation in the tube, and pulse oximetry monitoring.
Epigastric compression was performed by applying pressure to the epigastric region at least three times with the volar side of the intubated patient while the patient was ventilated with a balloon-valved mask. During this procedure, the fluctuation of the air and fluid in the stomach inside the esophageal tube can be observed and its sound can be heard. It can be applied from the first inhalation.
The ultrasonography (USG) procedure was evaluated by placing a linear ultrasound probe [SonoSite M-Turbo linear probe (13-6 MHz), Sonosite, Inc, Bothell, WA, USA] in the transverse position on the anterior side of the neck, just above the suprasternal notch, and observing the position of the tube (presence of a double path sign) and pleural sliding movement. While a single semicircular echogenic area is observed when the tube is in the trachea, a second semicircular echogenic area is observed when the tube is located in the esophagus. USG was performed immediately after the ETE procedure. In patients in whom double pathway sign was observed and pleural sliding motion was not observed, the patient was re-intubated by the experienced specialist performing USG. It was confirmed by USG again. These procedures were categorized as "failed".
partial endtidal carbon dioxide (PETCO2) measurement by capnography was performed using a mainstream EMMA® Capnograph (PHASEIN AB Svärdvägen, Danderyd, Sweden) for intubated patients. It was assessed by the detection of PETCO2 greater than 5 mmHg after five breaths and the appearance of a typical square waveform.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Endotracheal intubation | Other | Device: Endotracheal intubationPatients admitted to the emergency department between 01/05/2021 and 30/05/2022, who were older than 18 years of age and who underwent ETE outside the hospital or within the first hour of arrival to the emergency department were included in the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Older than 18 years of age
- Underwent ETE outside the hospital or within the first hour of arrival to the emergency department
Key exclusion criteria (3 listed)
- Patients in whom ETE was previously confirmed by USG or PETCO2,
- Patients intubated at external centers
- Patients who had known airway stenosis
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 |
|---|---|---|
| Endotracheal intubationThe first 40 successful and the first 40 unsuccessful ETE procedures were included in the study. | Device | Endotracheal intubation |
Primary outcome
Confirmation with ultrasonography: Successful or Failed
Time frame: 13 months
Fluctuation with Epigastric Compression: Yes or No Failed Successful Failed
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 7 Aug 2024.
- Results publication: PubMed 34870234Farrokhi M, Yarmohammadi B, Mangouri A, Hekmatnia Y, Bahramvand Y, Kiani M, Nasrollahi E, Nazari-Sabet M, Manoochehri-Arash N, Khurshid M, Mosalanejad S, Hajizadeh V, Amani-Beni R, Moallem M, Farahmandsadr M. Screening Performance Characteristics of Ultrasonography in Confirmation of Endotracheal Intubation; a Systematic Review and Meta-analysis. Arch Acad Emerg Med. 2021 Oct 26;9(1):e68. doi: 10.22037/aaem.v9i1.1360. eCollection 2021.
- Results publication: PubMed 36780595Li X, Zhang J, Karunakaran M, Hariharan VS. Diagnostic accuracy of ultrasonography for the confirmation of endotracheal tube intubation: a systematic review and meta-analysis. Med Ultrason. 2023 Mar 30;25(1):72-81. doi: 10.11152/mu-3594. Epub 2022 Jun 3.
- Results publication: PubMed 17999713Kramer-Johansen J, Dorph E, Steen PA. Detection of carbon dioxide in expired air after oesophageal intubation; the role of bystander mouth-to-mouth ventilation. Acta Anaesthesiol Scand. 2008 Jan;52(1):155-7. doi: 10.1111/j.1399-6576.2007.01503.x. Epub 2007 Nov 12.
- Individual participant dataSharing planned: No. Data can be shared with those who request it.
Related trials for Intubation, Intratracheal
Not yet recruitingObservational study
AI-assisted Tracheal Intubation in Children
Intubation
Not yet recruiting
AI Smart Glasses Feedback for Intubation Training in Medical Students
Intubation, Intratracheal, Medical Education
Recruiting
Development and Preliminary Validation of Intelligent Video Laryngoscope for Emergency Use
Critically Ill Patients Requiring Mechanical Ventilation
Recruiting
Effect of a Brief Educational Intervention on Endotracheal Tube Cuff Pressure
Intubation, Endotracheal Tube Cuff Pressure
Recruiting
Hyperangulated vs Standard Videolaryngoscopy vs Direct Laryngoscopy for Double-Lumen Endobronchial Tube Intubation
Endobronchial Intubation, Double Lumen Tube Intubation
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.
Mustafa Boğan, MD study director
Duzce University, School of Medicine, 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 Endotracheal intubation in people with Intubation, Intratracheal, run by Duzce 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 2 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 7 Aug 2024. 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?
Confirmation with ultrasonography: Successful or Failed (time frame: 13 months). 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 NCT06542406, which also lists 3 linked publications.
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 7 Aug 2024.