NCT06374030

Brief 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.

Trial Health

57
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2019

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 20, 2024

Completed
29 days until next milestone

First Posted

Study publicly available on registry

April 18, 2024

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

July 3, 2024

Status Verified

July 1, 2024

Enrollment Period

5 years

First QC Date

March 20, 2024

Last Update Submit

July 1, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

  • Intubator characteristics

    At the time of intervention and consequent 1 hour

  • Indication for intubation

    At the time of intervention and consequent 1 hour

  • Sedation agent used

    At the time of intervention and consequent 1 hour

  • +4 more other outcomes

Study Arms (1)

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

Interventions

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

patients who underwent the intervention of endotracheal intubation

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability 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)

You may qualify if:

  • All patients who underwent endotracheal intubation between 01-01-2019 and 31-12-2023 in the participating ED's

You may not qualify if:

  • Patients for which no information about the intubation can be found in the electronic patient chart will be excluded from the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Leeuwarden Medical Centre

Leeuwarden, 8934AD, Netherlands

RECRUITING

MeSH Terms

Interventions

Intubation, Intratracheal

Intervention Hierarchy (Ancestors)

Airway ManagementTherapeuticsIntubationInvestigative Techniques

Central Study Contacts

Peter Veldhuis, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 20, 2024

First Posted

April 18, 2024

Study Start

January 1, 2019

Primary Completion

December 31, 2023

Study Completion

December 31, 2024

Last Updated

July 3, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations