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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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

Other trials in Germany

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.

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 groups in NCT05635500
Study groupRoleWhat they receive
Middle InsertionExperimentalVideolaryngoscope is inserted from the middle for endotracheal intubation.
Receives: Procedure: Different Approach to endotracheal intubation.
Right InsertionNo interventionVideolaryngoscope 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.

  1. Comack-Lehane Classification

    Laryngeal vision is determined by Cormack/Lehane classification (C/L)

    Measured: immediately after the intervention

Secondary outcomes (5)
  1. Time to intubate

    Defined as time between endotracheal tube passing the lips till blocking of the cuff.

    Measured: immediately after the intervention

  2. First pass success

    Defined as no further attempts has been taken.

    Measured: immediately after the intervention

  3. 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

  4. 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

  5. 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.

  1. First posted2 Dec 2022
  2. Study start1 Aug 2021
  3. Primary completion25 May 2023
  4. Study completion26 May 2023

Resources

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)
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

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.

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