- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06653166
Retrospective Data Analysis With the Aim to Determine the Success Rate of Endotracheal Intubation in the First Attempt in the Zug Rescue Service With Various Airway Devices Already in Everyday Use (AWARE)
March 29, 2025 updated by: Rettungsdienst Zug
Retrospektive Analyse Von Patientendaten bezüglich Die notfallmässige Atemwegssicherungen Durch Den Rettungsdienst Zug (Airway Management Analysis in the Rescue Environment of the Emergency Service Zug) - Retrospective Analysis of Patient Data Regarding the Emergency Airway Management by the Rescue Service Zug
Airway management is a critical procedure in emergency medicine, especially endotracheal intubation, which can be life-saving.
Various techniques, such as video laryngoscopes and conventional laryngoscopes, are used, with success depending on first-pass success.
The aim of this retrospective data analysis is to determine the success rate of endotracheal intubation in the first attempt in the Zug Rescue Service between 01/20 and 01/25 with various airway management devices already used in everyday life.
The individual complications should secondary with regard to frequency and category as well as possible risk factors.
risk factors.
The aim is to examine the data on airway management of patients who had to be intubated due to a critical illness (e.g.
impaired oxygenation or ventilation, reduced vigilance, cardiovascular arrest, etc.).
The data is continuously collected and evaluated by the RDZ as part of quality assurance.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Detailed Description
Securing the airway is a critical aspect of pre-hospital emergency medicine and a complex, often life-saving measure.
Endotracheal intubation in particular is a key intervention to ensure adequate oxygenation and ventilation in critically ill or injured patients and to secure the airway.
Despite the development of alternative airway devices, the endotracheal tube remains the gold standard in prehospital emergency care due to its reliability and ability to safely protect the airway from aspiration.
The ability to perform rapid and successful endotracheal intubation is critical for healthcare professionals, as failure to secure the airway significantly increases mortality and morbidity.
Failure to intubate the trachea on the first attempt (lack of first-pass success) occurs in up to 20% of tracheal intubations in the emergency department or intensive care unit and up to 40% of prehospital intubations and is associated with an increased risk of severe hypoxemia, aspiration, cardiac arrest and death.
Given the often challenging conditions in the prehospital environment - such as limited space, suboptimal lighting and time pressure - mastering this technique becomes even more important.
The airway should therefore be secured under the best possible conditions and with the aid of appropriate airway adjuncts.
Despite advances, the optimal choice of laryngoscope and supportive devices remains a controversial topic in clinical practice with recommendations for the primary use of a video laryngoscope with a Macintosh-like blade in emergency medicine.
Commonly used approaches to airway management include: the hyperangulated video laryngoscope, the video laryngoscope with Macintosh blade, the conventional laryngoscope, each in combination with a stylet or bougie.
Each of these methods offers specific advantages and disadvantages that may be relevant in different clinical scenarios.
In previous studies under everyday conditions and in simulations, video laryngoscopy showed mixed results compared to conventional laryngoscopy in terms of first-pass success (especially in experienced users) with a trend towards increased success rates for the first intubation attempt with video laryngoscopy and a better view of the glottis.
The hyperangulated video laryngoscope promises an improved view of the glottis, especially in difficult airways, while the video laryngoscope with Macintosh blade bridges the gap between conventional and video-assisted laryngoscopy.
The conventional laryngoscope is still widely used.
The respective laryngoscopes are often supplemented by the use of a guide rod or a bougie (tube introducer) to facilitate intubation.
Some of the comparative studies conducted to date have shown a trend towards better first-pass success using a bougie, but were also inconclusive.
Despite numerous studies on individual aspects of these aids, a comparison of the methods in combination in real prehospital situations is still lacking.
In addition, the data regarding first-pass success in endotracheal intubation is unclear when comparing medical and non-medical personnel - some studies showed no differences, while others showed a higher success rate for emergency medical personnel.
Our retrospective study aims to close these gaps in knowledge by systematically examining the success rates, number of attempts to successful intubation, complication rates and ease of use of each method.
The purpose of this data analysis is to develop evidence-based recommendations for the choice of the optimal airway adjunct and thus improve patient safety and the efficiency of prehospital airway management standards, thereby reducing mortality.
The prehospital and clinical data already collected as part of the internal quality management of the emergency medical services offers the opportunity to determine the incidence of the important first-pass success with various airway devices and to record previously reported complications and incidents by evaluating the internal quality management system that has already been in operation for many years.
Study Type
Observational
Enrollment (Estimated)
200
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Zug, Switzerland, 6300
- Rettungsdienst Zug
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
The aim is to examine the data on airway management in the Zug Rescue Service who had to be intubated due to a critical illness (e.g.
oxygenation or ventilation disorder, reduced vigilance, cardiovascular arrest, etc.).
The data is continuously collected and evaluated by the RDZ as part of quality assurance.
Description
Inclusion Criteria:
- All adult patients who have had their airway secured by endotracheal intubation by RDZ staff
Exclusion Criteria:
- Existence of a documented refusal.
- Age < 18 years.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
videolaryngocopy with bougie (S Guide)
|
bougie (S Guide)
videolaryngoscopy hyperangulated or Macintosh
|
|
conventional laryngoscopy with bougie (S Guide)
|
bougie (S Guide)
|
|
videolaryngoscopy with introducer
|
videolaryngoscopy hyperangulated or Macintosh
|
|
conventional laryngoscopy with introducer
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Success rate (first pass success) with Video laryngoscope with Macintosh blade "C-MAC" used in the Zug rescue service
Time Frame: January 2020 to January 2025
|
January 2020 to January 2025
|
|
Success rate (first pass success) with the hyperangulated video laryngoscope "D-BLADE" in the Zug rescue service
Time Frame: January 2020 to January 2025
|
January 2020 to January 2025
|
|
Success rate (first pass success) with Conventional laryngoscope in the Zug rescue service
Time Frame: January 2020 to January 2025
|
January 2020 to January 2025
|
|
Success rate (first pass success) with Surgical airway protection in the Zug rescue service
Time Frame: January 2020 to January 2025
|
January 2020 to January 2025
|
|
Success rate (first pass success) with the Bougie/tube introducer in the Zug rescue service
Time Frame: January 2020 to January 2025
|
January 2020 to January 2025
|
|
Success rate (first pass success) with the Stylet/guide rod in the Zug rescue service
Time Frame: January 2020 to January 2025
|
January 2020 to January 2025
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Incidence of airways retrospectively assessed as definitively difficult
Time Frame: January 2020 to January 2025
|
proportion of "definitive difficult airway" to "anticipated difficult airway" and "unanticipated difficult airway"
|
January 2020 to January 2025
|
|
Incidence of mechanical damage
Time Frame: January 2020 to January 2025
|
January 2020 to January 2025
|
|
|
Portion of Medical/non-medical occupational patients
Time Frame: January 2020 to January 2025
|
January 2020 to January 2025
|
|
|
Incidence of drop in saturation SpO2 <90%
Time Frame: January 2020 to January 2025
|
January 2020 to January 2025
|
|
|
Correlation of succes rate and years of clinical experience of the intubator
Time Frame: January 2020 to January 2025
|
January 2020 to January 2025
|
|
|
Proportion of day or night shift on intubations with first pass effect
Time Frame: January 2020 to January 2025
|
January 2020 to January 2025
|
|
|
Patient demographics (median age, proportion of gender)
Time Frame: January 2020 to January 2025
|
January 2020 to January 2025
|
|
|
Reason for initiating resuscitation/DAI
Time Frame: January 2020 to January 2025
|
January 2020 to January 2025
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Benedikt Florian Scherr, MD, Rettungsdienst Zug
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 1, 2024
Primary Completion (Estimated)
May 1, 2025
Study Completion (Estimated)
July 1, 2025
Study Registration Dates
First Submitted
October 18, 2024
First Submitted That Met QC Criteria
October 19, 2024
First Posted (Actual)
October 22, 2024
Study Record Updates
Last Update Posted (Actual)
April 3, 2025
Last Update Submitted That Met QC Criteria
March 29, 2025
Last Verified
October 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AWARE
- 2024-02051 (Other Identifier: Ethics Committee Northwestern and Central Switzerland EKNZ)
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
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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