Retrospective Study of Airway Management in Dutch ED's

• ClinicalTrials.gov Identifier: NCT06374030
• Recruitment Status: Active, not recruiting
• First Posted: April 18, 2024
• Last Update Posted: April 18, 2024
• Sponsor: Medical Centre Leeuwarden
• Collaborators: VieCuri Medical Centre; Catharina Ziekenhuis Eindhoven; Rijnstate Hospital; Zuyderland Medical Centre
• Information provided by (Responsible Party): Peter Veldhuis, Medical Centre Leeuwarden

Tracking Information

• First Submitted Date: March 20, 2024
• First Posted Date: April 18, 2024
• Last Update Posted Date: April 18, 2024
• Actual Study Start Date: January 1, 2019
• Actual Primary Completion Date: December 31, 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 15, 2024)

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

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided

Current Other Pre-specified Outcome Measures (submitted: April 15, 2024)

• Intubator characteristics [ Time Frame: At the time of intervention and consequent 1 hour ]
  Specialty and function/seniority of the intubator
• 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
• Sedation agent used [ Time Frame: At the time of intervention and consequent 1 hour ]
  Ketamine, etomidate, propofol, midazolam
• Paralytic agent used [ Time Frame: At the time of intervention and consequent 1 hour ]
  Rocuronium / Succinylcholine
• Sedative agent after intubation [ Time Frame: At the time of intervention and consequent 1 hour ]
  Propofol Fentanyl Midazolam Morphine Ketamine Other Not indicated
• Method of intubation [ Time Frame: At the time of intervention and consequent 1 hour ]
  Direct laryngoscopy Video (hyperangulated or direct) Fiberoptic Surgical airway
• 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)

• Original Other Pre-specified Outcome Measures: Same as current

Descriptive Information

• Brief Title: Retrospective Study of Airway Management in Dutch ED's
• Official Title: A Retrospective Study on the Practice and Safety of Airway Management in Dutch Emergency Departments
• 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.

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
• Study Design: Observational Model: Cohort; Time Perspective: Retrospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• 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)
• Condition: Endotracheal Intubation

Intervention

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

Study Groups/Cohorts

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.

Intervention: Procedure: Endotracheal intubation

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Active, not recruiting
• Estimated Enrollment (submitted: April 15, 2024): 1000
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 31, 2024
• Actual Primary Completion Date: December 31, 2023 (Final data collection date for primary outcome measure)

Eligibility Criteria

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: Child, Adult, Older Adult
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Netherlands

Administrative Information

• NCT Number: NCT06374030
• Other Study ID Numbers: EDSAM2024
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Peter Veldhuis, Medical Centre Leeuwarden
• Original Responsible Party: Same as current
• Current Study Sponsor: Medical Centre Leeuwarden
• Original Study Sponsor: Same as current

Collaborators

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

• Investigators: Not Provided
• PRS Account: Medical Centre Leeuwarden
• Verification Date: April 2024