Difficult IntubationNCT03403946
Macintosh and D-Blade® in Simulated Difficult Airway
A study testing Macintosh blade, D-Blade and Intubation in people with Difficult Intubation and Cervical Injury Spine, run by Johann Wolfgang Goethe University Hospital at 1 site in Germany.
Trial summary
In the presented study, our aim was to compare intubation conditions regarding the modified Cormack \& Lehane score (CL) between the D-Blade® in indirect laryngoscopy or Macintosh blade in direct and indirect laryngoscopy with C-MAC PM® in a simulated setting of a difficult airway in human subjects. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Difficult Intubation, Cervical Injury Spine
- What is being tested?
- Macintosh blade, D-Blade and Intubation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteGermany
- Study dates
- 1 Dec 2011to 31 Aug 2012
- Phase
- Interventional
- 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 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients requiring general anesthesia for orthopedic surgery
Who cannot join
- known or expected difficult airway
- undergoing urgent or emergent surgery
- non-fasted
- American Society of Anesthesiology Class (ASA) IV-VI
- no consent for participation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Direct and Indirect Laryngoscopy Using C-MAC PM® With Macintosh Blade and D-Blade® in Simulated Difficult Airway
In the presented study, our aim was to compare intubation conditions regarding the modified Cormack \& Lehane score (CL) between the D-Blade® in indirect laryngoscopy or Macintosh blade in direct and indirect laryngoscopy with C-MAC PM® in a simulated setting of a difficult airway in human subjects.
Read the detailed description
Patients with unexpected difficult airway requiring endotracheal intubation (ETI) remain extremely challenging for emergency physicians and intubation failure with subsequent hypoxic complications still represents the majority of cases in a recent closed claims analysis.
An incidence of major complications in airway management of 1 in 5,500 was estimated in the Fourth National Audit Project in the UK.
Therefore, our aim was to compare intubation conditions regarding the modified Cormack \& Lehane score (CL) between the D-Blade® in indirect laryngoscopy or Macintosh blade in direct and indirect laryngoscopy with C-MAC PM® in a simulated setting of a difficult airway in human subjects.
- Conditions
- Difficult Intubation, Cervical Injury Spine
- Being tested
- Macintosh blade, D-Blade, Intubation
- Keywords
- difficult airway, carvical collar, endotracheal intubation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Macintosh bladeDevice
Laryngoscopy with C-MAC PM in combination with Macintosh blade
D-BladeDevice
Laryngoscopy with C-MAC PM in combination with D-Blade
IntubationDevice
Intubation with C-MAC PM in combination with D-Blade
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | All patients received the same treatment.
1. Laryngscopy with C-MAC PM + Macintosh blade
2. Laryngscopy with C-MAC PM + D-Blade
3. Intubation with C-MAC PM + D-Blade Receives: Device: Macintosh blade; Device: D-Blade; Device: Intubation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Best view of the glottic structures
Best view of the glottic structures according to the modified Cormack and Lehane (CL) scoring system
Measured: 120 seconds after induction of narcosis
Secondary outcomes (2)
Evaluate the process of Intubation using a questionnaire
As a secondary endpoint, all investigators were asked to evaluate the process of ETI with the D-Blade® from grade 1 to grade 4.
Grade 1: Uncomplicated ETI with guide rod Grade 2: Challenging ETI, readjustment or usage of BURP necessary Grade 3: ETI using a stylet Grade 4: ETI failed
Measured: Directly after successful tracheal intubation
Subjective assessment of satisfaction using numeric rating scale
Finally, all investigators were asked for their subjective assessment from 0 = dissatisfied to 100 = fully satisfied when using the D-Blade®.
Measured: Directly after successful tracheal intubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2018
- Study start1 Dec 2011
- Primary completion29 Feb 2012
- Study completion31 Aug 2012
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 Difficult IntubationStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johann Wolfgang Goethe University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. med. Florian Raimann, Johann Wolfgang Goethe University Hospital
- Investigators
- Haitham Mutlak, Dr. med., Study director, Department of Anesthesia, Intensive Care Medicine and Pain Therapy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03403946
- Sponsor's protocol ID
- 126/11
- Status last verified
- Jan 2018
- First submitted
- 6 Jan 2018
- Last updated
- 23 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Raimann FJ, Dietze PE, Cuca CE, Meininger D, Kessler P, Byhahn C, Gill-Schuster D, Zacharowski K, Mutlak H. Prospective Trial to Compare Direct and Indirect Laryngoscopy Using C-MAC PM(R) with Macintosh Blade and D-Blade(R) in a Simulated Difficult Airway. Emerg Med Int. 2019 Apr 1;2019:1067473. doi: 10.1155/2019/1067473. eCollection 2019.
PubMed 31065384
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Direct and Indirect Laryngoscopy Using C-MAC PM® With Macintosh Blade and D-Blade® in Simulated Difficult Airway
- ClinicalTrials.gov ID
- NCT03403946
- Acronym / sponsor ID
- 126/11
- Conditions
- Difficult Intubation, Cervical Injury Spine
- Keywords
- difficult airway, carvical collar, endotracheal intubation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Johann Wolfgang Goethe University HospitalUniversity, hospital or other
- Study start
- 1 Dec 2011 (actual)
- Primary completion
- 29 Feb 2012 (actual)
- Study completion
- 31 Aug 2012 (actual)
- First posted
- 19 Jan 2018 (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.
In the presented study, our aim was to compare intubation conditions regarding the modified Cormack \& Lehane score (CL) between the D-Blade® in indirect laryngoscopy or Macintosh blade in direct and indirect laryngoscopy with C-MAC PM® in a simulated setting of a difficult airway in human subjects.
Detailed description
Patients with unexpected difficult airway requiring endotracheal intubation (ETI) remain extremely challenging for emergency physicians and intubation failure with subsequent hypoxic complications still represents the majority of cases in a recent closed claims analysis.
An incidence of major complications in airway management of 1 in 5,500 was estimated in the Fourth National Audit Project in the UK.
Therefore, our aim was to compare intubation conditions regarding the modified Cormack \& Lehane score (CL) between the D-Blade® in indirect laryngoscopy or Macintosh blade in direct and indirect laryngoscopy with C-MAC PM® in a simulated setting of a difficult airway in human subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Device: Macintosh blade, Device: D-Blade, Device: IntubationAll patients received the same treatment. 1. Laryngscopy with C-MAC PM + Macintosh blade 2. Laryngscopy with C-MAC PM + D-Blade 3. Intubation with C-MAC PM + D-Blade |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients requiring general anesthesia for orthopedic surgery
Key exclusion criteria (5 listed)
- known or expected difficult airway
- undergoing urgent or emergent surgery
- non-fasted
- American Society of Anesthesiology Class (ASA) IV-VI
- no consent for participation
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 |
|---|---|---|
| Macintosh bladeLaryngoscopy with C-MAC PM in combination with Macintosh blade | Device | Intervention |
| D-BladeLaryngoscopy with C-MAC PM in combination with D-Blade | Device | Intervention |
| IntubationIntubation with C-MAC PM in combination with D-Blade | Device | Intervention |
Primary outcome
Best view of the glottic structures
Time frame: 120 seconds after induction of narcosis
Best view of the glottic structures according to the modified Cormack and Lehane (CL) scoring system
2 secondary outcomes
Evaluate the process of Intubation using a questionnaire
Time frame: Directly after successful tracheal intubation
Subjective assessment of satisfaction using numeric rating scale
Time frame: Directly after successful tracheal intubation
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 23 Jan 2018.
- Derived from this study: PubMed 31065384Raimann FJ, Dietze PE, Cuca CE, Meininger D, Kessler P, Byhahn C, Gill-Schuster D, Zacharowski K, Mutlak H. Prospective Trial to Compare Direct and Indirect Laryngoscopy Using C-MAC PM(R) with Macintosh Blade and D-Blade(R) in a Simulated Difficult Airway. Emerg Med Int. 2019 Apr 1;2019:1067473. doi: 10.1155/2019/1067473. eCollection 2019.
- 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.
Haitham Mutlak, Dr. med. study director
Department of Anesthesia, Intensive Care Medicine and Pain Therapy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Macintosh blade, D-Blade and Intubation in people with Difficult Intubation and Cervical Injury Spine, run by Johann Wolfgang Goethe University Hospital 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 5 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 23 Jan 2018. 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?
Best view of the glottic structures (time frame: 120 seconds after induction of narcosis). 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 NCT03403946, 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 23 Jan 2018.