ED Airway Management in the Netherlands.

NCT06558630 | Recruiting DMC

• 1 other identifier: DEAR
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief 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. The objective of this study is to describe airway management in the Netherlands.

Conditions

Endotracheal Intubation

Keywords

Emergency department; Airway management

Outcome Measures

Primary Outcomes (1)

• 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

  Within 10 minutes after start of procedure. The data has to reported within 24 hours of endotracheal intubation.

Secondary Outcomes (2)

• First pass success

  Peri-intubation. The data has to reported within 24 hours of endotracheal intubation.

• Indications for intubation

  Peri-intubation. The data has to reported within 24 hours of endotracheal intubation.

Study Arms (1)

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.

Procedure: Endotracheal intubation

Interventions

Endotracheal intubation PROCEDURE

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.

Patient in need of airway management.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patiënts who require endotracheal intubation will be included. Population will therefore be limited to those needing airway management.

You may qualify if:

• All patients who undergo airway management in the ED.

You may not qualify if:

• ED patients that undergo airway management outside of the ED (e.g. operation room), will be excluded

Sponsors & Collaborators

• Frisius Medisch Centrum: lead

Study Sites (1)

Leeuwarden Medical Centre

Leeuwarden, 8934AD, Netherlands

RECRUITING

MeSH Terms

Conditions

Emergencies

Interventions

Intubation, Intratracheal

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Airway Management; Therapeutics; Intubation; Investigative Techniques

Central Study Contacts

P Veldhuis, MD

CONTACT

+3158 286 6666; peter.veldhuis@mcl.nl

J de Haan, MD

CONTACT

+3158 286 6666; jael.de.haan@mcl.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2024
• First Posted: August 19, 2024
• Study Start: January 1, 2024
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: August 23, 2024

Record last verified: 2024-08

Locations

NL (1)