Intubation; Difficult or FailedMidwayNCT05635500
Clinical Comparison Between Midline and Right-sided Insertion of the Videolaryngoscope for Endotracheal Intubation
A study testing Different Approach to endotracheal intubation. in people with Intubation; Difficult or Failed, run by Charite University, Berlin, Germany at 2 sites in Germany.
Trial summary
The videolaryngoscope is an established tool for securing the airway, even in difficult situations. It remains unclear which insertion technique is the safest and fastest in the difficult airway. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intubation; Difficult or Failed
- What is being tested?
- Different Approach to endotracheal intubation.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 184 participants
- Where
- 2 sitesGermany
- Study dates
- 1 Aug 2021to 26 May 2023
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Elective surgery under general anesthesia with indication for airway protection via endotracheal intubation
- age ≥ 18 years
- indication for primary videolaryngoscopic Intubation (VLS) and/or at least one of the following criteria:
- Mallampati ≥ 3
- Thyromental distance <6.5cm
- Sternalomental distance <12.5 cm
- Conversion from conventional laryngoscopy to VLS in history
- Cervical spine immobilization/lack of ability to recline.
Who cannot join
- Pregnant patients
- Participation in another prospective clinical intervention study within the last 30 days and during participation in this study
- Necessary Rapid Sequence Induction
- Indications of impossible mask ventilation and/or videolaryngoscopy (mouth opening < 3.5 cm, ...)
- Existence of tracheal cannula prior to operation
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
Campus Benjamin Franklin, Charité - Universitätsmedizin Berlin
Berlin, 12203
Department of Anesthesia and operative intensive Care, Campus Benjamin Franklin, Charité - University Hospital Berlin
Steglitz, State of Berlin, 12203
About this study
Official title: Clinical Comparison Between Midline and Right-sided Insertion of the Videolaryngoscope for Intubation - a Randomized, Controlled, Prospective Clinical Trial
The videolaryngoscope is an established tool for securing the airway, even in difficult situations. It remains unclear which insertion technique is the safest and fastest in the difficult airway.
Read the detailed description
Videolaryngoscopy is one of the standard methods of airway management in the Department of Anesthesiology with Surgical Intensive Care, is anchored in the applicable Standard Operating Procedures (SOP) and is used in everyday clinical practice.
In order to establish the above-mentioned generality, the patients are divided into 2 groups. In the preoperative visit, the patients are divided into easy and difficult airway, and a randomization regarding the induction technique is done paper-based after induction of anesthesia.
Patients* identified in the preoperative visit with a risk for difficult intubation or difficult laryngoscopy (Mallampati ≥ 3, thyromental distance below 6.5cm, sternomental distance below 12.5cm, conversion from conventional laryngoscopy to VLS in the history, cervical spine immobilization, lack of possibility for reclination) are randomized into one of the two groups:
Group DR (difficult right) corresponds here to the right-sided insertion technique in the difficult airway.
Group DM (difficult middle) corresponds to the middle access route in the difficult airway.
Perioperatively, standard monitoring is performed according to the hospital's SOP, consisting of a 3-point ECG recording, non-invasive blood pressure measurement, pulse oximetry, respiratory gas monitoring and the recording of a processed EEG for hyponosis depth measurement. To ensure and document optimal muscle relaxation, we perform relaxometry.
In accordance with the hospital's internal SOP, anesthesia induction is performed after sufficient preoxygenation with opiates, hypnotics and muscle relaxants. All drugs are administered in accordance with the operation-specific, internal hospital standards.
In addition to the basic measures, the standardized, extended measures for the management of a difficult airway are all fulfilled in the DR and DM groups and documented by means of a checklist. These include optimized positioning and adequate depth of anesthesia, as well as the provision and use of various aids such as a guide rod or frovacatheter.
Prior to videolaryngoscopy, a mouth guard is inserted unless contraindicated for airway protection.
This is followed by videolaryngoscopy with insertion of the videolaryngoscope according to the assigned group, and then insertion of the endotracheal tube.
The visualization of the laryngeal plane using the Cormack/Lehane score, Video Classification of Intubation (VCI) score and the different process times of airway protection are documented in addition to the vital signs and train-of-four (TOF).
In addition to the video laryngoscope to optimize visualization, standardized advanced techniques for laryngoscopy as well as for intubation are used and documented if necessary.
In addition, the anatomic, pathologic, and other typical conditions that caused the current difficult intubation are documented.
The laryngoscopy including intubation is recorded via the VLS in the form of a video. This allows an assessment of the visual scores by an independent observer*. Blinding cannot take place due to the different insertion techniques. The video recording only shows the inside of the mouth and larynx.
Side effects/complications are recorded on the 1st postoperative day by means of a short visit and standardized questionnaire according to localization (sore throat, hoarseness, mucosal lesions, dysphagia, dental damage) and differentiated according to the extent to which these complaints can be attributed to the surgical intervention and/or airway protection.
- Conditions
- Intubation; Difficult or Failed
- Being tested
- Different Approach to endotracheal intubation.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Different Approach to endotracheal intubation.Procedure or surgery
Different insertion way.
| Study group | Role | What they receive |
|---|---|---|
| Middle Insertion | Experimental | Videolaryngoscope is inserted from the middle for endotracheal intubation. Receives: Procedure: Different Approach to endotracheal intubation. |
| Right Insertion | No intervention | Videolaryngoscope is inserted from the right for endotracheal intubation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comack-Lehane Classification
Laryngeal vision is determined by Cormack/Lehane classification (C/L)
Measured: immediately after the intervention
Secondary outcomes (5)
Time to intubate
Defined as time between endotracheal tube passing the lips till blocking of the cuff.
Measured: immediately after the intervention
First pass success
Defined as no further attempts has been taken.
Measured: immediately after the intervention
Time to laryngeal view
Defined as time from the insertion of the laryngoscope till position of the best overview of the larynx.
Measured: immediately after the intervention
Complications during induction
Defined as hemodynamic changes (bradycardia < 60 bpm, tachycardia >100 bpm, hypotension < 65 mmHG MAD, hypertension > 100 mmHG MAD), Oxygendesaturation <92 % SpO2, the need for further equipment (e.g. flexible bronchoscope), bleedings or a surgical airway
Measured: 15 minutes
Complication on first postoperative day
Definde as the occurence of swelling, bleedings, damage on teeth, throat hoarseness
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2022
- Study start1 Aug 2021
- Primary completion25 May 2023
- Study completion26 May 2023
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 Intubation; Difficult or FailedStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Computer generates randomisation in two groups middle insertion (n=92) and right insertion (n=92)
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 184 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sascha Treskatsch, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05635500
- Sponsor's protocol ID
- EA2/121/21
- Acronym
- Midway
- Status last verified
- Feb 2024
- First submitted
- 22 Jul 2021
- Last updated
- 13 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jiang L, Qiu S, Zhang P, Yao W, Chang Y, Dai Z. The midline approach for endotracheal intubation using GlideScope video laryngoscopy could provide better glottis exposure in adults: a randomized controlled trial. BMC Anesthesiol. 2019 Nov 5;19(1):200. doi: 10.1186/s12871-019-0876-6.
PubMed 31690285
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Comparison Between Midline and Right-sided Insertion of the Videolaryngoscope for Intubation - a Randomized, Controlled, Prospective Clinical Trial
- ClinicalTrials.gov ID
- NCT05635500
- Acronym / sponsor ID
- Midway / EA2/121/21
- Conditions
- Intubation; Difficult or Failed
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 184 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- 25 May 2023 (actual)
- Study completion
- 26 May 2023 (actual)
- First posted
- 2 Dec 2022 (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.
The videolaryngoscope is an established tool for securing the airway, even in difficult situations. It remains unclear which insertion technique is the safest and fastest in the difficult airway.
Detailed description
Videolaryngoscopy is one of the standard methods of airway management in the Department of Anesthesiology with Surgical Intensive Care, is anchored in the applicable Standard Operating Procedures (SOP) and is used in everyday clinical practice.
In order to establish the above-mentioned generality, the patients are divided into 2 groups. In the preoperative visit, the patients are divided into easy and difficult airway, and a randomization regarding the induction technique is done paper-based after induction of anesthesia.
Patients* identified in the preoperative visit with a risk for difficult intubation or difficult laryngoscopy (Mallampati ≥ 3, thyromental distance below 6.5cm, sternomental distance below 12.5cm, conversion from conventional laryngoscopy to VLS in the history, cervical spine immobilization, lack of possibility for reclination) are randomized into one of the two groups:
Group DR (difficult right) corresponds here to the right-sided insertion technique in the difficult airway.
Group DM (difficult middle) corresponds to the middle access route in the difficult airway.
Perioperatively, standard monitoring is performed according to the hospital's SOP, consisting of a 3-point ECG recording, non-invasive blood pressure measurement, pulse oximetry, respiratory gas monitoring and the recording of a processed EEG for hyponosis depth measurement. To ensure and document optimal muscle relaxation, we perform relaxometry.
In accordance with the hospital's internal SOP, anesthesia induction is performed after sufficient preoxygenation with opiates, hypnotics and muscle relaxants. All drugs are administered in accordance with the operation-specific, internal hospital standards.
In addition to the basic measures, the standardized, extended measures for the management of a difficult airway are all fulfilled in the DR and DM groups and documented by means of a checklist. These include optimized positioning and adequate depth of anesthesia, as well as the provision and use of various aids such as a guide rod or frovacatheter.
Prior to videolaryngoscopy, a mouth guard is inserted unless contraindicated for airway protection.
This is followed by videolaryngoscopy with insertion of the videolaryngoscope according to the assigned group, and then insertion of the endotracheal tube.
The visualization of the laryngeal plane using the Cormack/Lehane score, Video Classification of Intubation (VCI) score and the different process times of airway protection are documented in addition to the vital signs and train-of-four (TOF).
In addition to the video laryngoscope to optimize visualization, standardized advanced techniques for laryngoscopy as well as for intubation are used and documented if necessary.
In addition, the anatomic, pathologic, and other typical conditions that caused the current difficult intubation are documented.
The laryngoscopy including intubation is recorded via the VLS in the form of a video. This allows an assessment of the visual scores by an independent observer*. Blinding cannot take place due to the different insertion techniques. The video recording only shows the inside of the mouth and larynx.
Side effects/complications are recorded on the 1st postoperative day by means of a short visit and standardized questionnaire according to localization (sore throat, hoarseness, mucosal lesions, dysphagia, dental damage) and differentiated according to the extent to which these complaints can be attributed to the surgical intervention and/or airway protection.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Computer generates randomisation in two groups middle insertion (n=92) and right insertion (n=92)
| Arm | Type | Receives |
|---|---|---|
| Middle Insertion | Experimental | Procedure: Different Approach to endotracheal intubation.Videolaryngoscope is inserted from the middle for endotracheal intubation. |
| Right Insertion | No intervention | –Videolaryngoscope is inserted from the right for endotracheal intubation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Elective surgery under general anesthesia with indication for airway protection via endotracheal intubation
- age ≥ 18 years
- indication for primary videolaryngoscopic Intubation (VLS) and/or at least one of the following criteria:
Key exclusion criteria (5 listed)
- Pregnant patients
- Participation in another prospective clinical intervention study within the last 30 days and during participation in this study
- Necessary Rapid Sequence Induction
- Indications of impossible mask ventilation and/or videolaryngoscopy (mouth opening < 3.5 cm, ...)
- Existence of tracheal cannula prior to operation
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 |
|---|---|---|
| Different Approach to endotracheal intubation.Different insertion way. | Procedure or surgery | Middle Insertion |
Primary outcome
Comack-Lehane Classification
Time frame: immediately after the intervention
Laryngeal vision is determined by Cormack/Lehane classification (C/L)
5 secondary outcomes
Time to intubate
Time frame: immediately after the intervention
First pass success
Time frame: immediately after the intervention
Time to laryngeal view
Time frame: immediately after the intervention
Complications during induction
Time frame: 15 minutes
Complication on first postoperative day
Time frame: 24 hours
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 13 Feb 2024.
- Background: PubMed 31690285Jiang L, Qiu S, Zhang P, Yao W, Chang Y, Dai Z. The midline approach for endotracheal intubation using GlideScope video laryngoscopy could provide better glottis exposure in adults: a randomized controlled trial. BMC Anesthesiol. 2019 Nov 5;19(1):200. doi: 10.1186/s12871-019-0876-6.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Different Approach to endotracheal intubation. in people with Intubation; Difficult or Failed, run by Charite University, Berlin, Germany at 2 sites 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 8 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 13 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Comack-Lehane Classification (time frame: immediately after the intervention). 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 NCT05635500, 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 13 Feb 2024.