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NCT Number: NCT06374030

Retrospective Study of Airway Management in Dutch ED's

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.

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Key information

Conditions

Endotracheal Intubation

Sex eligibility

All sexes

Study type

Observational

Primary location

Leeuwarden Medical Centre

Leeuwarden, 8934AD, Netherlands

Location status: Recruiting

Location contact

Peter Veldhuis, MD

CONTACT

[email protected]

+3158 286 6666

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Endotracheal Intubation

Procedure

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

Primary outcomes

  1. 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

Other outcomes

  1. Intubator characteristics

    Time frame: At the time of intervention and consequent 1 hour

    Specialty and function/seniority of the intubator

  2. Indication for intubation

    Time frame: At the time of intervention and consequent 1 hour

    Indications could be:

    Trauma Burns Drowning Overdose/ingestion Respiratory failure Cardiac arrest (active cardiac arrest) Post-cardiac arrest Stroke Seizure Altered mental status due to other cause (if altered mental status due to stroke, intoxication, seizure or post-cardiac arrest then score as the primary cause) Sepsis Cardiac failure Airway obstruction GI bleed Anaphylaxis Other

  3. Sedation agent used

    Time frame: At the time of intervention and consequent 1 hour

    Ketamine, etomidate, propofol, midazolam

  4. Paralytic agent used

    Time frame: At the time of intervention and consequent 1 hour

    Rocuronium / Succinylcholine

  5. Sedative agent after intubation

    Time frame: At the time of intervention and consequent 1 hour

    Propofol Fentanyl Midazolam Morphine Ketamine Other Not indicated

  6. Method of intubation

    Time frame: At the time of intervention and consequent 1 hour

    Direct laryngoscopy Video (hyperangulated or direct) Fiberoptic Surgical airway

  7. Patient characteristics

    Time frame: At the time of intervention and consequent 1 hour

    Demographics of the patient who underwent endotracheal intubation. Such as age (years), gender (male/female), weight/obesity (BMI)

Study contacts

Contact information is provided by the study sponsor or research team.

Peter Veldhuis, MD

CONTACT

[email protected]

+3158 286 6666

Sponsors and collaborators

Lead sponsor

Frisius Medisch Centrum

Other

Collaborators

  • Catharina Ziekenhuis Eindhoven
  • Rijnstate Hospital
  • VieCuri Medical Centre
  • Zuyderland Medical Centre

Registry information

Official study title

A Retrospective Study on the Practice and Safety of Airway Management in Dutch Emergency Departments

Important dates

Study start
2019
Primary completion
2023
Study completion
2024
First posted
Apr 18, 2024
Registry last updated
Jul 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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