Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05635500 |
| Other study ID # |
EA2/121/21 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
August 1, 2021 |
| Est. completion date |
May 26, 2023 |
Study information
| Verified date |
February 2024 |
| Source |
Charite University, Berlin, Germany |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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.
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.
