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.
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
- Conditions the study is for
- Respiratory Insufficiency, Intubation, Airway Management
- 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.
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.
- Conditions
- Respiratory Insufficiency, Intubation, Airway Management, Prehospital Airway Management in Patients With Cardiac Arrest, Prehospital Emergency Medical Services, Videolaryngoscopy
- 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 group | Role | What 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 introducer | Not described Receives: Device: videolaryngoscopy | |
| conventional laryngoscopy with introducer | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Success rate (first pass success) with the hyperangulated video laryngoscope "D-BLADE" in the Zug rescue service
Measured: January 2020 to January 2025
Success rate (first pass success) with Conventional laryngoscope in the Zug rescue service
Measured: January 2020 to January 2025
Success rate (first pass success) with Surgical airway protection in the Zug rescue service
Measured: January 2020 to January 2025
Success rate (first pass success) with the Bougie/tube introducer in the Zug rescue service
Measured: January 2020 to January 2025
Success rate (first pass success) with the Stylet/guide rod in the Zug rescue service
Measured: January 2020 to January 2025
Secondary outcomes (8)
Incidence of mechanical damage
Measured: January 2020 to January 2025
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
Portion of Medical/non-medical occupational patients
Measured: January 2020 to January 2025
Incidence of drop in saturation SpO2 <90%
Measured: January 2020 to January 2025
Correlation of succes rate and years of clinical experience of the intubator
Measured: January 2020 to January 2025
Proportion of day or night shift on intubations with first pass effect
Measured: January 2020 to January 2025
Patient demographics (median age, proportion of gender)
Measured: January 2020 to January 2025
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.
- First posted22 Oct 2024
- Study start1 Dec 2024
- Primary completion1 May 2025 (estimated)
- Study completion1 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Respiratory InsufficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Rettungsdienst Zug
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Benedikt Florian Scherr, MD, Principal investigator, Rettungsdienst Zug
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
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06653166
- Acronym / sponsor ID
- AWARE / AWARE
- Conditions
- Respiratory Insufficiency, Intubation, Airway Management, Prehospital Airway Management in Patients With Cardiac Arrest, Prehospital Emergency Medical Services, Videolaryngoscopy
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Rettungsdienst ZugOther government
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 1 May 2025 (estimated)
- Study completion
- 1 Jul 2025 (estimated)
- First posted
- 22 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| videolaryngocopy with bougie (S Guide) | – | Device: bougie (S Guide), Device: videolaryngoscopy |
| conventional laryngoscopy with bougie (S Guide) | – | Device: bougie (S Guide) |
| videolaryngoscopy with introducer | – | Device: videolaryngoscopy |
| conventional laryngoscopy with introducer | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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.
Key inclusion criteria (1 listed)
- All adult patients who have had their airway secured by endotracheal intubation by RDZ staff
Key exclusion criteria (2 listed)
- Existence of a documented refusal.
- Age < 18 years.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| bougie (S Guide)bougie (S Guide) | Device | conventional laryngoscopy with bougie (S Guide), videolaryngocopy with bougie (S Guide) |
| videolaryngoscopyvideolaryngoscopy hyperangulated or Macintosh | Device | videolaryngocopy with bougie (S Guide), videolaryngoscopy with introducer |
Primary outcome
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
Success rate (first pass success) with the hyperangulated video laryngoscope "D-BLADE" in the Zug rescue service
Time frame: 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
Success rate (first pass success) with Surgical airway protection in the Zug rescue service
Time frame: 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
Success rate (first pass success) with the Stylet/guide rod in the Zug rescue service
Time frame: January 2020 to January 2025
8 secondary outcomes
Incidence of mechanical damage
Time frame: January 2020 to January 2025
Incidence of airways retrospectively assessed as definitively difficult
Time frame: January 2020 to January 2025
Portion of Medical/non-medical occupational patients
Time frame: January 2020 to January 2025
Incidence of drop in saturation SpO2 <90%
Time frame: January 2020 to January 2025
Correlation of succes rate and years of clinical experience of the intubator
Time frame: January 2020 to January 2025
Proportion of day or night shift on intubations with first pass effect
Time frame: January 2020 to January 2025
Patient demographics (median age, proportion of gender)
Time frame: January 2020 to January 2025
Reason for initiating resuscitation/DAI
Time frame: January 2020 to January 2025
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2025.
- Derived from this study: PubMed 41126289Brinkmann 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Benedikt Florian Scherr, MD principal investigator
Rettungsdienst Zug
1 site in 1 country: see every site and its status.
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.