Endotracheal IntubationNCT06374030
Retrospective Study of Airway Management in Dutch ED's
An observational study of Endotracheal Intubation, run by Frisius Medisch Centrum at 1 site in Netherlands.
Trial summary
Describing characteristics of the practice of airway management in Dutch emergency departments, including information about patient demographics, indications, performer characteristics, equipment and medication used and complications due to intubation. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Endotracheal Intubation
- What is being tested?
- Endotracheal intubation
- Type of treatment
- Surgery or procedure
- How many people
- 1,000 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Jan 2019to 31 Dec 2024
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients who underwent endotracheal intubation between 01-01-2019 and 31-12-2023 in the participating ED's (Leeuwarden Medical Centre, VieCuri Medical Centre, Catharina Hospital, Rijnstate Hospital, Zuyderland Medical Centre)
Who may be able to join
- All patients who underwent endotracheal intubation between 01-01-2019 and 31-12-2023 in the participating ED's
Who cannot join
- Patients for which no information about the intubation can be found in the electronic patient chart will be excluded from the study.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Leeuwarden Medical Centre
Leeuwarden, 8934AD
Peter Veldhuis, MD, +3158 286 6666, peter.veldhuis@mcl.nl
About this study
Official title: A Retrospective Study on the Practice and Safety of Airway Management in Dutch Emergency Departments
Describing characteristics of the practice of airway management in Dutch emergency departments, including information about patient demographics, indications, performer characteristics, equipment and medication used and complications due to intubation.
Read the detailed description
Endotracheal intubation can be a lifesaving intervention for critically ill patients in the emergency department (ED). Endotracheal intubation is, however, a high-risk procedure with many potential complications, which seem to be even more prevalent when carried out in the ED compared to for example the operating theater. This is possibly due to multiple reasons such as a sicker population, non-elective setting, a higher variability among indications for intubation or competence of providers.
Internationally, large registries were established and multiple observational studies have been performed to gain more information about the methods, safety and complications of intubations in the ED. While in recent years these studies have added to our knowledge of ED airway management, there is still a lack of high-quality studies and there is a strong argument for increased research. To date, no studies have been published of airway management in Dutch EDs. The investigators therefore have no knowledge about any factors possibly influencing intubation outcomes and complications nor comparability with international data. Among these are factors that have been associated with preventable harm and death and insight into these factors could be used for improvement of the safety of airway management in Dutch EDs.
This study is therefore intended to provide a comprehensive review of the clinical practice and characteristics of endotracheal intubations within Dutch EDs. The results could potentially be used for comparative analysis against global datasets. Additionally, the insights gained from this study will shed light on existing gaps prevalent in the current registration processes of intubations in the Netherlands. Furthermore, these insights could act as a stepping stone for future investigations that can lead to a deeper understanding of the methodologies, safety protocols, and associated complications of endotracheal intubations within Dutch EDs
- Conditions
- Endotracheal Intubation
- Being tested
- Endotracheal intubation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endotracheal intubationProcedure or surgery
All endotracheal intubations carried out in the emergency department of one of the participating hospitals in the time period 01-01-2019 - 31-12-2023
| Study group | Role | What they receive |
|---|---|---|
| patients who underwent the intervention of endotracheal intubation | Inclusion criteria:
All patients who underwent endotracheal intubation between 01-01-2019 and 31-12-2023 in the participating ED's.
Exclusion criteria:
Patients for which no information about the intubation can be found in the electronic patient chart will be excluded from the study. Receives: Procedure: Endotracheal intubation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Different complications of endotracheal intubation
- significant decrease of SpO2. Defined as: desaturation of >10% from baseline or as defined by the treating physician
- significant decrease of blood pressure. Defined as: systolic pressure <90mmHg with a drop of >20% from baseline or as defined by the treating physician.
- significant increase of blood pressure. Defined as: systolic pressure > 160mmHg with a rise of >20% from baseline, or as defined by the treating physician.
- significant bradycardia. Defined as: heart rate < 40/min and a drop of > 20% from baseline, or as defined by the treating physician.
- significant tachycardia. Defined as: heart rate > 160/min and a rise of > 20% from baseline, or as defined by the treating physician.
- dental or airway trauma
- oesophageal or mainstem bronchial intubation
- vomiting or aspiration
- laryngospasm
- equipment failure
- medication error
- cardiac arrest
- failed attempt / need for an emergency surgical airway
- other
Measured: At the time of intervention and consequent 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2024
- Study start1 Jan 2019
- Primary completion31 Dec 2023
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endotracheal IntubationStudies 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
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Frisius Medisch Centrum
- Sponsor type
- University, hospital or other
- Collaborators
- VieCuri Medical Centre, Catharina Ziekenhuis Eindhoven, Rijnstate Hospital, Zuyderland Medical Centre
- Responsible party
- Principal investigator, Peter Veldhuis, Frisius Medisch Centrum
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06374030
- Sponsor's protocol ID
- EDSAM2024
- Status last verified
- Jul 2024
- First submitted
- 20 Mar 2024
- Last updated
- 3 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Study on the Practice and Safety of Airway Management in Dutch Emergency Departments
- ClinicalTrials.gov ID
- NCT06374030
- Acronym / sponsor ID
- EDSAM2024
- Conditions
- Endotracheal Intubation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Frisius Medisch CentrumUniversity, hospital or other
- Collaborators
- VieCuri Medical Centre, Catharina Ziekenhuis Eindhoven, Rijnstate Hospital, Zuyderland Medical Centre
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 18 Apr 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.
Describing characteristics of the practice of airway management in Dutch emergency departments, including information about patient demographics, indications, performer characteristics, equipment and medication used and complications due to intubation.
Detailed description
Endotracheal intubation can be a lifesaving intervention for critically ill patients in the emergency department (ED). Endotracheal intubation is, however, a high-risk procedure with many potential complications, which seem to be even more prevalent when carried out in the ED compared to for example the operating theater. This is possibly due to multiple reasons such as a sicker population, non-elective setting, a higher variability among indications for intubation or competence of providers.
Internationally, large registries were established and multiple observational studies have been performed to gain more information about the methods, safety and complications of intubations in the ED. While in recent years these studies have added to our knowledge of ED airway management, there is still a lack of high-quality studies and there is a strong argument for increased research. To date, no studies have been published of airway management in Dutch EDs. The investigators therefore have no knowledge about any factors possibly influencing intubation outcomes and complications nor comparability with international data. Among these are factors that have been associated with preventable harm and death and insight into these factors could be used for improvement of the safety of airway management in Dutch EDs.
This study is therefore intended to provide a comprehensive review of the clinical practice and characteristics of endotracheal intubations within Dutch EDs. The results could potentially be used for comparative analysis against global datasets. Additionally, the insights gained from this study will shed light on existing gaps prevalent in the current registration processes of intubations in the Netherlands. Furthermore, these insights could act as a stepping stone for future investigations that can lead to a deeper understanding of the methodologies, safety protocols, and associated complications of endotracheal intubations within Dutch EDs
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients who underwent the intervention of endotracheal intubation | – | Procedure: Endotracheal intubationInclusion criteria: All patients who underwent endotracheal intubation between 01-01-2019 and 31-12-2023 in the participating ED's. Exclusion criteria: Patients for which no information about the intubation can be found in the electronic patient chart will be excluded from the study. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients who underwent endotracheal intubation between 01-01-2019 and 31-12-2023 in the participating ED's (Leeuwarden Medical Centre, VieCuri Medical Centre, Catharina Hospital, Rijnstate Hospital, Zuyderland Medical Centre)
Key inclusion criteria (1 listed)
- All patients who underwent endotracheal intubation between 01-01-2019 and 31-12-2023 in the participating ED's
Key exclusion criteria (1 listed)
- Patients for which no information about the intubation can be found in the electronic patient chart will be excluded from the study.
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 intubationAll endotracheal intubations carried out in the emergency department of one of the participating hospitals in the time period 01-01-2019 - 31-12-2023 | Procedure or surgery | patients who underwent the intervention of endotracheal intubation |
Primary outcome
Different complications of endotracheal intubation
Time frame: At the time of intervention and consequent 1 hour
* significant decrease of SpO2. Defined as: desaturation of >10% from baseline or as defined by the treating physician * significant decrease of blood pressure. Defined as: systolic pressure <90mmHg with a drop of >20% from baseline or as defined by the treating physician. * significant increase of blood pressure. Defined as: systolic pressure > 160mmHg with a rise of >20% from baseline, or as defined by the treating physician. * significant bradycardia. Defined as: heart rate < 40/min and a drop of > 20% from baseline, or as defined by the treating physician. * significant tachycardia. Defined as: heart rate > 160/min and a rise of > 20% from baseline, or as defined by the treating physician. * dental or airway trauma * oesophageal or mainstem bronchial intubation * vomiting or aspiration * laryngospasm * equipment failure * medication error * cardiac arrest * failed attempt / need for an emergency surgical airway * other
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2024.
- 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.
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 Intubation, run by Frisius Medisch Centrum at 1 site in Netherlands.
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: status not confirmed, as of the sponsor's last update on 3 Jul 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 Netherlands. 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 Peter Veldhuis, MD (+3158 286 6666, peter.veldhuis@mcl.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Different complications of endotracheal intubation (time frame: At the time of intervention and consequent 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 3 Jul 2024.