VideolaryngoscopyAwakeNCT05802316
Awake Tracheal Intubation in Critical Care Patients
An observational study of Videolaryngoscopy and Intensive Care Unit Syndrome, run by Johannes Gutenberg University Mainz at 1 site in Germany.
Trial summary
Tracheal intubation in critical care is a high-risk procedure requiring significant expertise and airway strategy modifications, such as awake intubation with video laryngoscope or flexible endoscope intubation. Furthermore, delayed sequence intubation can be used by experts in certain high-risk subgroups. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Videolaryngoscopy, Intensive Care Unit Syndrome
- What is being tested?
- tracheal intubation using videolaryngoscope with a hyperangulated blade or standard intubation videolaryngoscopy (VL) and direct laryngoscopy (DL)
- Type of treatment
- Medical device
- How many people
- 140 participants
- Where
- 1 siteGermany
- Study dates
- 3 Jan 2020to 3 Nov 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: critical care patients requiring tracheal intubation
Who may be able to join
- Data for all critical care patients requiring tracheal intubation during the study period
Who cannot join
- included incomplete data reports
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Anesthesiology,Prof. C. Werner, Universitätsmedizin of the JG University
Mainz, Rhineland-Palatinate, D55131
About this study
Official title: Awake Tracheal Intubation is Associated With Fewer Adverse Events in Critical Care Patients Than Standard Tracheal Intubation
Tracheal intubation in critical care is a high-risk procedure requiring significant expertise and airway strategy modifications, such as awake intubation with video laryngoscope or flexible endoscope intubation. Furthermore, delayed sequence intubation can be used by experts in certain high-risk subgroups. The investigators hypothesise that awake tracheal intubation is associated with a lower incidence of severe adverse events than standard tracheal intubation in critical care patients.
Read the detailed description
Intubation records from 2020 to 2022 were acquired to examine all tracheal intubations of critical care patients at a tertiary hospital. Each awake tracheal intubation (awake) case - all of which were performed using a videolaryngoscope with a hyperangulated blade - was propensity matched with two controls (1:2 ratio; standard intubation videolaryngoscopy (VL) and direct laryngoscopy (DL) undergoing general anaesthesia), with similar comorbidities and intubations performed after the induction of anaesthesia (asleep).
- Conditions
- Videolaryngoscopy, Intensive Care Unit Syndrome
- Being tested
- tracheal intubation using videolaryngoscope with a hyperangulated blade or standard intubation videolaryngoscopy (VL) and direct laryngoscopy (DL)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tracheal intubation using videolaryngoscope with a hyperangulated blade or standard intubation videolaryngoscopy (VL) and direct laryngoscopy (DL)Device
In the awake group tracheal intubation performed by an videolaryngoscope with a hyperangulated blade. In the asleep group the standard intubation were performed by videolaryngoscopy (VL) and direct laryngoscopy (DL)
| Study group | Role | What they receive |
|---|---|---|
| awake | awake tracheal intubation Receives: Device: tracheal intubation using videolaryngoscope with a hyperangulated blade or standard intubation videolaryngoscopy (VL) and direct laryngoscopy (DL) | |
| asleep | standard intubation videolaryngoscopy (VL) and direct laryngoscopy (DL) Receives: Device: tracheal intubation using videolaryngoscope with a hyperangulated blade or standard intubation videolaryngoscopy (VL) and direct laryngoscopy (DL) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hypotension
defined as a mean arterial pressure < 55 mmHg
Measured: during intubation procedure (within 30 Minutes)
cardiac arrest
defined as a peri-interventional cardiac arrest
Measured: during intubation procedure (within 30 Minutes)
desaturation
defined as SpO2 < 80% after sufficient preoxygenation
Measured: during intubation procedure (within 30 Minutes)
Secondary outcomes (4)
Cormack and Lehane classification (Class I-IV)
glottis visualisation
Measured: during intubation procedure (< 120 seconds)
FPS
First Pass Intubation success
Measured: during intubation procedure (< 120 seconds)
Airway Injury
dental injury
Measured: during intubation procedure (< 120 seconds)
other adverse events
soft tissue injury
Measured: during intubation procedure (< 120 seconds)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2023
- Study start3 Jan 2020
- Primary completion30 Apr 2022
- Study completion3 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VideolaryngoscopyStudies 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
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johannes Gutenberg University Mainz
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marc Kriege, MD, Johannes Gutenberg University Mainz
- Investigators
- Marc Kriege, Principal investigator, University Medical Centre Mainz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05802316
- Sponsor's protocol ID
- JohannesGUK
- Acronym
- Awake
- Status last verified
- Apr 2023
- First submitted
- 22 Mar 2023
- Last updated
- 6 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Awake Tracheal Intubation is Associated With Fewer Adverse Events in Critical Care Patients Than Standard Tracheal Intubation
- ClinicalTrials.gov ID
- NCT05802316
- Acronym / sponsor ID
- Awake / JohannesGUK
- Conditions
- Videolaryngoscopy, Intensive Care Unit Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Johannes Gutenberg University MainzUniversity, hospital or other
- Study start
- 3 Jan 2020 (actual)
- Primary completion
- 30 Apr 2022 (actual)
- Study completion
- 3 Nov 2022 (actual)
- First posted
- 6 Apr 2023 (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.
Tracheal intubation in critical care is a high-risk procedure requiring significant expertise and airway strategy modifications, such as awake intubation with video laryngoscope or flexible endoscope intubation. Furthermore, delayed sequence intubation can be used by experts in certain high-risk subgroups. The investigators hypothesise that awake tracheal intubation is associated with a lower incidence of severe adverse events than standard tracheal intubation in critical care patients.
Detailed description
Intubation records from 2020 to 2022 were acquired to examine all tracheal intubations of critical care patients at a tertiary hospital. Each awake tracheal intubation (awake) case - all of which were performed using a videolaryngoscope with a hyperangulated blade - was propensity matched with two controls (1:2 ratio; standard intubation videolaryngoscopy (VL) and direct laryngoscopy (DL) undergoing general anaesthesia), with similar comorbidities and intubations performed after the induction of anaesthesia (asleep).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| awake | – | Device: tracheal intubation using videolaryngoscope with a hyperangulated blade or standard intubation videolaryngoscopy (VL) and direct laryngoscopy (DL)awake tracheal intubation |
| asleep | – | Device: tracheal intubation using videolaryngoscope with a hyperangulated blade or standard intubation videolaryngoscopy (VL) and direct laryngoscopy (DL)standard intubation videolaryngoscopy (VL) and direct laryngoscopy (DL) |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- critical care patients requiring tracheal intubation
Key inclusion criteria (1 listed)
- Data for all critical care patients requiring tracheal intubation during the study period
Key exclusion criteria (1 listed)
- included incomplete data reports
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 |
|---|---|---|
| tracheal intubation using videolaryngoscope with a hyperangulated blade or standard intubation videolaryngoscopy (VL) and direct laryngoscopy (DL)In the awake group tracheal intubation performed by an videolaryngoscope with a hyperangulated blade. In the asleep group the standard intubation were performed by videolaryngoscopy (VL) and direct laryngoscopy (DL) | Device | asleep, awake |
Primary outcome
Hypotension
Time frame: during intubation procedure (within 30 Minutes)
defined as a mean arterial pressure < 55 mmHg
cardiac arrest
Time frame: during intubation procedure (within 30 Minutes)
defined as a peri-interventional cardiac arrest
desaturation
Time frame: during intubation procedure (within 30 Minutes)
defined as SpO2 < 80% after sufficient preoxygenation
4 secondary outcomes
Cormack and Lehane classification (Class I-IV)
Time frame: during intubation procedure (< 120 seconds)
FPS
Time frame: during intubation procedure (< 120 seconds)
Airway Injury
Time frame: during intubation procedure (< 120 seconds)
other adverse events
Time frame: during intubation procedure (< 120 seconds)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2023.
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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.
Marc Kriege principal investigator
University Medical Centre Mainz
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 Videolaryngoscopy and Intensive Care Unit Syndrome, run by Johannes Gutenberg University Mainz at 1 site in Germany.
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 1 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: finished, as of the sponsor's last update on 6 Apr 2023. 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 Germany. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Hypotension (time frame: during intubation procedure (within 30 Minutes)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Apr 2023.