Retrospective Study of Airway Management in Dutch ED's

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.

Study Overview

• Status: Recruiting
• Conditions: Endotracheal Intubation
• Intervention / Treatment: Procedure: Endotracheal 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 Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

• Study Contact: Name: Peter Veldhuis, MD; Phone Number: +3158 286 6666; Email: peter.veldhuis@mcl.nl

Study Locations

• Netherlands
  • Leeuwarden, Netherlands, 8934AD
    • Recruiting
    • Leeuwarden Medical Centre
    • Contact: Peter Veldhuis, MD; Phone Number: +3158 286 6666; Email: peter.veldhuis@mcl.nl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

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)

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Procedure: Endotracheal intubation; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	At the time of intervention and consequent 1 hour

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intubator characteristics	Specialty and function/seniority of the intubator	At the time of intervention and consequent 1 hour
Indication for intubation	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	At the time of intervention and consequent 1 hour
Sedation agent used	Ketamine, etomidate, propofol, midazolam	At the time of intervention and consequent 1 hour
Paralytic agent used	Rocuronium / Succinylcholine	At the time of intervention and consequent 1 hour
Sedative agent after intubation	Propofol Fentanyl Midazolam Morphine Ketamine Other Not indicated	At the time of intervention and consequent 1 hour
Method of intubation	Direct laryngoscopy Video (hyperangulated or direct) Fiberoptic Surgical airway	At the time of intervention and consequent 1 hour
Patient characteristics	Demographics of the patient who underwent endotracheal intubation. Such as age (years), gender (male/female), weight/obesity (BMI)	At the time of intervention and consequent 1 hour

Collaborators and Investigators

• Sponsor: Medical Centre Leeuwarden
• Collaborators: Catharina Ziekenhuis Eindhoven; Rijnstate Hospital; VieCuri Medical Centre; Zuyderland Medical Centre

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2019
• Primary Completion (Actual): December 31, 2023
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: March 20, 2024
• First Submitted That Met QC Criteria: April 15, 2024
• First Posted (Actual): April 18, 2024

Study Record Updates

• Last Update Posted (Actual): July 3, 2024
• Last Update Submitted That Met QC Criteria: July 1, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: EDSAM2024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No