Endotracheal IntubationDEARNCT06558630
ED Airway Management in the Netherlands.
An observational study of Endotracheal Intubation, run by Frisius Medisch Centrum at 1 site in Netherlands.
Trial summary
Airway management is one of the resuscitative procedures patients may undergo in the Emergency Department (ED). While this is a high risk procedure, to date there is no data available on airway management practices, success or safety in EDs in the Netherlands. 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 2024to 1 Jan 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 patiënts who require endotracheal intubation will be included. Population will therefore be limited to those needing airway management.
Who may be able to join
- All patients who undergo airway management in the ED.
Who cannot join
- ED patients that undergo airway management outside of the ED (e.g. operation room), will be excluded
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
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 Prospective Observational Cohort Study of Airway Management in Emergency Departments in the Netherlands.
Airway management is one of the resuscitative procedures patients may undergo in the Emergency Department (ED). While this is a high risk procedure, to date there is no data available on airway management practices, success or safety in EDs in the Netherlands. The objective of this study is to describe airway management in the Netherlands.
Read the detailed description
Airway management is the planning, preparation and execution of medical interventions to maintain a patients airway and thereby maintaining or supporting the patients respiration. While the term is used for a range of techniques, the technique that is most studied and relevant in the emergency department (ED) is endotracheal intubation. Endotracheal intubation is an important procedure in emergency care with a broad range of indications. Examples are altered mental status due to trauma, intoxication or stroke, respiratory failure due to respiratory diseases such as pneumonia and airway obstruction due to trauma or allergic reactions.
While endotracheal intubation can be a lifesaving intervention, it can also result in complications such as airway trauma, aspiration, hypoxia, hypotension and cardiac arrest . Peri-intubation adverse events have been reported in 12-26% of intubations. For example, Alkhouri et al reported that ED intubations were complicated by desaturation (11.9%), hypotension (7.1%), aspiration (2.7%) and cardiac arrest (1%). These complications are relatively more frequent in the ED than in the operating room, and they also seem to result in more harm. One study reported a 38-fold higher incidence of brain damage or death as result of an airway event in the ED compared to the operating room. These differences are most likely caused by multiple factors, such as anatomical and physiological difficulties of airway management due to the underlying pathology of the ED patient, training of providers and available equipment in the ED.
Valuable information about the practice of airway management in the ED can derived from one of the large national and international ED airway registries. Examples are the National Emergency Airway Registry (NEAR), the Australia and New Zealand Emergency Department Airway Registry (ANZEDAR) and the Japanese Emergency Airway management (JEAN). These registries have described indications, providers, techniques, success and adverse events of airway management in the ED. This data has also provided insights into factors that are related with success of intubation on one hand, and the occurrence of complications on the other. For example, the NEAR registry showed that the use of video laryngoscopy was associated with a higher rate of successful intubations at the first attempt than with direct laryngoscopy in trauma patients and patients with signs of a difficult anatomical airway. In these patients the rate of oesophageal intubation was lower when video laryngoscopy was used. The ANZEDAR registry showed that intubations were more often complicated by hypotension when propofol was given as induction agent and that intubations were less often complicated by hypoxia when apnoeic oxygenation was used. Furthermore, data from these registries also show trends in the practice of airway management. For example, where only the minority of patients in the JEAN registry was intubated using rapid sequence induction (RSI) at the start of the registry, now the majority of patients is intubated using RSI. Video laryngoscopy was increasingly used during the study period in the NEAR and JEAN registries, while in the ANZEDAR registry the use of ketamine as an induction agent has significantly increased throughout the years. All in all, ED registries have provided a valuable contribution to our knowledge of ED airway management.
To date, no data has been published about airway management in EDs in the Netherlands. While the aforementioned ED registries do provide information, it is unknown to what extend those findings can be translated to the Netherlands. First of all, there is variation in the practice of airway management between the registries. For example, when comparing induction agents that are used for intubation, there is great variability between ED airway registries. In the NEAR registry etomidate was used in the great majority of intubations, while in the JEAN registry midazolam was used most often. For intubations in the ANZEDAR registry ketamine, propofol and thiopentone were used in approximately equal proportions. Considering the variations between these registries, it is difficult to make assumptions about which drugs are used in the Netherlands for airway management. Furthermore, certain features of ED care in the Netherlands differ from the countries that participated in the registries. In the NEAR, ANZEDAR and JEAN registries the intubations were mainly performed by emergency physicians. However, according to a national survey only a minority of emergency physicians in the Netherlands perform intubations. It is unclear to what extent findings of these ED registries match the current practices of airway management in EDs in the Netherlands.
The goal of this study is to provide a compressive overview of airway management practice in Dutch EDs and to provide input for quality assessment, quality improvement and future interventional studies.
- Conditions
- Endotracheal Intubation
- Being tested
- Endotracheal intubation
- Keywords
- Emergency department, Airway management
- Medical subject headings
- Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endotracheal intubationProcedure or surgery
Over the course of several years as many as possible ED centres in the Netherlands will be included in the collection of all data involving airway management. Airway management is defined as the process of planning, preparation and execution of endotracheal intubation.
| Study group | Role | What they receive |
|---|---|---|
| Patient in need of airway management. | All patients who undergo airway management in de ED. In this study, airway management is defined as the process of planning, preparation and execution of endotracheal intubation. While the term airway management can also be used for techniques such as placing an oropharyngeal tube, patients are only included if endotracheal intubation is attempted. Receives: Procedure: Endotracheal intubation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events during or after endotracheal intubation
The occurrence of adverse events peri-intubation, the following adverse events are defined:
- Desaturation, defined as a decrease of SpO2 of 10% or more
- Hypotension, defined as a systolic blood pressure of <90mmHg AND a decrease of 20% or more. In case of suspected raised intracranial pressure hypotension is defined as a systolic blood pressure of <120mmHg AND a decrease of 20% or more.
- Hypertension
- Bradycardia
- Tachycardia
- Cardiac arrest
- Aspiration
- Oesophageal intubation
- Mainstem intubation
- Dental trauma
- Airway bleeding due to intubation attempt
- Other adverse event, further specified by provider
Measured: Within 10 minutes after start of procedure. The data has to reported within 24 hours of endotracheal intubation.
Secondary outcomes (2)
First pass success
The percentage of patients that are successfully intubated during the first attempt of endotracheal intubation. An attempt is defined as an attempt to visualize the larynx and an attempt ends when the laryngoscope blade is removed from the mouth.
Measured: Peri-intubation. The data has to reported within 24 hours of endotracheal intubation.
Indications for intubation
The underlying pathology that led to the decision to intubate, these are defined as:
- Pulmonary
- Cardiac
- Neurologic
- Cardiac arrest
- Post-cardiac arrest
- Intoxication
- Metabolic derangement
- Trauma
- Shock
- Airway obstruction
- Other
Measured: Peri-intubation. The data has to reported within 24 hours of endotracheal intubation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2024
- Study start1 Jan 2024
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Jan 2027 (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
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Frisius Medisch Centrum
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06558630
- Sponsor's protocol ID
- DEAR
- Acronym
- DEAR
- Status last verified
- Aug 2024
- First submitted
- 11 Apr 2024
- Last updated
- 23 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Observational Cohort Study of Airway Management in Emergency Departments in the Netherlands.
- ClinicalTrials.gov ID
- NCT06558630
- Acronym / sponsor ID
- DEAR / DEAR
- Conditions
- Endotracheal Intubation
- Keywords
- Emergency department, Airway management
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Frisius Medisch CentrumUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 19 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.
Airway management is one of the resuscitative procedures patients may undergo in the Emergency Department (ED). While this is a high risk procedure, to date there is no data available on airway management practices, success or safety in EDs in the Netherlands. The objective of this study is to describe airway management in the Netherlands.
Detailed description
Airway management is the planning, preparation and execution of medical interventions to maintain a patients airway and thereby maintaining or supporting the patients respiration. While the term is used for a range of techniques, the technique that is most studied and relevant in the emergency department (ED) is endotracheal intubation. Endotracheal intubation is an important procedure in emergency care with a broad range of indications. Examples are altered mental status due to trauma, intoxication or stroke, respiratory failure due to respiratory diseases such as pneumonia and airway obstruction due to trauma or allergic reactions.
While endotracheal intubation can be a lifesaving intervention, it can also result in complications such as airway trauma, aspiration, hypoxia, hypotension and cardiac arrest . Peri-intubation adverse events have been reported in 12-26% of intubations. For example, Alkhouri et al reported that ED intubations were complicated by desaturation (11.9%), hypotension (7.1%), aspiration (2.7%) and cardiac arrest (1%). These complications are relatively more frequent in the ED than in the operating room, and they also seem to result in more harm. One study reported a 38-fold higher incidence of brain damage or death as result of an airway event in the ED compared to the operating room. These differences are most likely caused by multiple factors, such as anatomical and physiological difficulties of airway management due to the underlying pathology of the ED patient, training of providers and available equipment in the ED.
Valuable information about the practice of airway management in the ED can derived from one of the large national and international ED airway registries. Examples are the National Emergency Airway Registry (NEAR), the Australia and New Zealand Emergency Department Airway Registry (ANZEDAR) and the Japanese Emergency Airway management (JEAN). These registries have described indications, providers, techniques, success and adverse events of airway management in the ED. This data has also provided insights into factors that are related with success of intubation on one hand, and the occurrence of complications on the other. For example, the NEAR registry showed that the use of video laryngoscopy was associated with a higher rate of successful intubations at the first attempt than with direct laryngoscopy in trauma patients and patients with signs of a difficult anatomical airway. In these patients the rate of oesophageal intubation was lower when video laryngoscopy was used. The ANZEDAR registry showed that intubations were more often complicated by hypotension when propofol was given as induction agent and that intubations were less often complicated by hypoxia when apnoeic oxygenation was used. Furthermore, data from these registries also show trends in the practice of airway management. For example, where only the minority of patients in the JEAN registry was intubated using rapid sequence induction (RSI) at the start of the registry, now the majority of patients is intubated using RSI. Video laryngoscopy was increasingly used during the study period in the NEAR and JEAN registries, while in the ANZEDAR registry the use of ketamine as an induction agent has significantly increased throughout the years. All in all, ED registries have provided a valuable contribution to our knowledge of ED airway management.
To date, no data has been published about airway management in EDs in the Netherlands. While the aforementioned ED registries do provide information, it is unknown to what extend those findings can be translated to the Netherlands. First of all, there is variation in the practice of airway management between the registries. For example, when comparing induction agents that are used for intubation, there is great variability between ED airway registries. In the NEAR registry etomidate was used in the great majority of intubations, while in the JEAN registry midazolam was used most often. For intubations in the ANZEDAR registry ketamine, propofol and thiopentone were used in approximately equal proportions. Considering the variations between these registries, it is difficult to make assumptions about which drugs are used in the Netherlands for airway management. Furthermore, certain features of ED care in the Netherlands differ from the countries that participated in the registries. In the NEAR, ANZEDAR and JEAN registries the intubations were mainly performed by emergency physicians. However, according to a national survey only a minority of emergency physicians in the Netherlands perform intubations. It is unclear to what extent findings of these ED registries match the current practices of airway management in EDs in the Netherlands.
The goal of this study is to provide a compressive overview of airway management practice in Dutch EDs and to provide input for quality assessment, quality improvement and future interventional studies.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient in need of airway management. | – | Procedure: Endotracheal intubationAll patients who undergo airway management in de ED. In this study, airway management is defined as the process of planning, preparation and execution of endotracheal intubation. While the term airway management can also be used for techniques such as placing an oropharyngeal tube, patients are only included if endotracheal intubation is attempted. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patiënts who require endotracheal intubation will be included. Population will therefore be limited to those needing airway management.
Key inclusion criteria (1 listed)
- All patients who undergo airway management in the ED.
Key exclusion criteria (1 listed)
- ED patients that undergo airway management outside of the ED (e.g. operation room), will be excluded
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 intubationOver the course of several years as many as possible ED centres in the Netherlands will be included in the collection of all data involving airway management. Airway management is defined as the process of planning, preparation and execution of endotracheal intubation. | Procedure or surgery | Patient in need of airway management. |
Primary outcome
Adverse events during or after endotracheal intubation
Time frame: Within 10 minutes after start of procedure. The data has to reported within 24 hours of endotracheal intubation.
The occurrence of adverse events peri-intubation, the following adverse events are defined: * Desaturation, defined as a decrease of SpO2 of 10% or more * Hypotension, defined as a systolic blood pressure of <90mmHg AND a decrease of 20% or more. In case of suspected raised intracranial pressure hypotension is defined as a systolic blood pressure of <120mmHg AND a decrease of 20% or more. * Hypertension * Bradycardia * Tachycardia * Cardiac arrest * Aspiration * Oesophageal intubation * Mainstem intubation * Dental trauma * Airway bleeding due to intubation attempt * Other adverse event, further specified by provider
2 secondary outcomes
First pass success
Time frame: Peri-intubation. The data has to reported within 24 hours of endotracheal intubation.
Indications for intubation
Time frame: Peri-intubation. The data has to reported within 24 hours of endotracheal intubation.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2024.
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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.
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: looking for participants now, as of the sponsor's last update on 23 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 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact P 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?
Adverse events during or after endotracheal intubation (time frame: Within 10 minutes after start of procedure. The data has to reported within 24 hours of endotracheal intubation.). 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 23 Aug 2024; AzTrials last refreshed its copy on 6 Nov 2026.