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Respiratory InsufficiencyAWARENCT06653166

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

An observational study of Respiratory Insufficiency and Intubation, run by Rettungsdienst Zug at 1 site in Switzerland.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
bougie (S Guide) and videolaryngoscopy
Type of treatment
Medical device
How many people
200 participants
Where
1 siteSwitzerland
Study dates
1 Dec 2024to 1 Jul 2025
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • All adult patients who have had their airway secured by endotracheal intubation by RDZ staff

Who cannot join

  • Existence of a documented refusal.
  • Age < 18 years.

Trial locations and contacts

1 site in 1 country.

Switzerland1 site
  • Rettungsdienst Zug

    Zug, 6300

Other trials in Switzerland

About this study

Official title: 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.

Read the 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.

Being tested
bougie (S Guide), videolaryngoscopy
Medical subject headings
Respiratory Insufficiency

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • bougie (S Guide)Device

    bougie (S Guide)

  • videolaryngoscopyDevice

    videolaryngoscopy hyperangulated or Macintosh

Study groups in NCT06653166
Study groupRoleWhat they receive
videolaryngocopy with bougie (S Guide)Not described
Receives: Device: bougie (S Guide); Device: videolaryngoscopy
conventional laryngoscopy with bougie (S Guide)Not described
Receives: Device: bougie (S Guide)
videolaryngoscopy with introducerNot described
Receives: Device: videolaryngoscopy
conventional laryngoscopy with introducerNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Success rate (first pass success) with Video laryngoscope with Macintosh blade "C-MAC" used in the Zug rescue service

    Measured: January 2020 to January 2025

  2. Success rate (first pass success) with the hyperangulated video laryngoscope "D-BLADE" in the Zug rescue service

    Measured: January 2020 to January 2025

  3. Success rate (first pass success) with Conventional laryngoscope in the Zug rescue service

    Measured: January 2020 to January 2025

  4. Success rate (first pass success) with Surgical airway protection in the Zug rescue service

    Measured: January 2020 to January 2025

  5. Success rate (first pass success) with the Bougie/tube introducer in the Zug rescue service

    Measured: January 2020 to January 2025

  6. Success rate (first pass success) with the Stylet/guide rod in the Zug rescue service

    Measured: January 2020 to January 2025

Secondary outcomes (8)
  1. Incidence of mechanical damage

    Measured: January 2020 to January 2025

  2. Incidence of airways retrospectively assessed as definitively difficult

    proportion of "definitive difficult airway" to "anticipated difficult airway" and "unanticipated difficult airway"

    Measured: January 2020 to January 2025

  3. Portion of Medical/non-medical occupational patients

    Measured: January 2020 to January 2025

  4. Incidence of drop in saturation SpO2 <90%

    Measured: January 2020 to January 2025

  5. Correlation of succes rate and years of clinical experience of the intubator

    Measured: January 2020 to January 2025

  6. Proportion of day or night shift on intubations with first pass effect

    Measured: January 2020 to January 2025

  7. Patient demographics (median age, proportion of gender)

    Measured: January 2020 to January 2025

  8. Reason for initiating resuscitation/DAI

    Measured: January 2020 to January 2025

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Oct 2024
  2. Study start1 Dec 2024
  3. Primary completion1 May 2025 (estimated)
  4. Study completion1 Jul 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06653166
Sponsor's protocol ID
AWARE
Other IDs
2024-02051
Acronym
AWARE
Status last verified
Oct 2024
First submitted
18 Oct 2024
Last updated
3 Apr 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Brinkmann F, Cajoeri G, Sahli SD, Buehler PK, Scherr BF. Airway management analysis in the rescue environment of the emergency service Zug: a retrospective real-world evaluation. Scand J Trauma Resusc Emerg Med. 2025 Oct 22;33(1):171. doi: 10.1186/s13049-025-01489-x.

    PubMed 41126289

Questions about this trial

What is this clinical trial studying?

An observational study of Respiratory Insufficiency and Intubation, run by Rettungsdienst Zug at 1 site in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 3 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06653166, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2025.

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