Conventional vs. Video-Assisted Laryngoscopy for Perioperative Endotracheal Intubation (COVALENT)

March 31, 2025 updated by: Wuerzburg University Hospital
COVALENT is a randomized, controlled, multi-center study that aims to evaluate the clinical routine practice of endotracheal intubation in an operative setting comparing video-assisted laryngoscopy to direct laryngoscopy.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Data on the routine use of video-assisted laryngoscopy in peri-operative intubations are rather inconsistent and ambiguous, in part due to small study populations and non-uniform outcome measures in past trials. Failed or prolonged intubation procedures are a reason for relevant morbidity and mortality. This study aims to determine whether video-assisted laryngoscopy (irrespective of the shape of the blade) is non-inferior to the standard method of direct laryngoscopy with respect to the first-pass success rate. Furthermore, validated tools from the field of human factors will be applied to examine within-team communication and task load during this critical medical procedure.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
2855

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Benedikt Schmid, MD, PhD
  • Phone Number: +49 931 201 30309
  • Email: schmid_b@ukw.de

Study Contact Backup

  • Name: Peter Kranke, MD, PhD
  • Phone Number: +49 931 201-30050
  • Email: kranke_p@ukw.de

Study Locations

  • Germany
      • Würzburg, Germany
        • University Hospital Wuerzburg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Adult, legally competent patients
  • Scheduled for elective, non-cardiac surgical procedure
  • Need for endotracheal intubation as determined during the premedication visit
  • Informed consent
  • Care providers performing the intubation have at least one year of training in anesthesiology and experience in the use of VAL

Exclusion Criteria:

  • Lack of ability to give consent
  • Previous participation in this study
  • Pregnancy
  • Need for fiberoptic intubation
  • Patients scheduled for bariatric surgery
  • Any circumstance that will lead the anesthesiologist(s) in charge to believe that random assignment of a laryngoscopy instrument may compromise patient safety during induction of anesthesia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: CDL
Conventional direct laryngoscopy using a Macintosh blade
Procedure: Conventional direct laryngoscopy (CDL)
This procedure is considered the gold standard for endotracheal intubation and is routinely used in the peri-operative setting as well as in intensive care and emergency medicine.
Other Names:
  • conventional direct laryngoscopy
  • conventional laryngoscopy
Experimental: M-VAL
Video assisted laryngoscopy with a Macintosh-shaped blade
Procedure: Video assisted laryngoscopy with Macintosh-shaped blade (M-VAL)
This device is implemented in most german hospitals and used when conventional direct laryngoscopy is not sufficient. By positioning the camera at the tip of the blade, the achievable field of view onto the glottic plane is improved.
Other Names:
  • video assisted laryngoscopy with Macintosh-shaped blade
Experimental: H-VAL
Video assisted laryngoscopy with a hyper-angulated blade
Procedure: Video assisted laryngoscopy with hyper-angulated blade (H-VAL)
The hyper-angulated blades are often used as a backup instrument when a view of the glottic plane cannot be achieved with the Macintosh blade due to anatomic abnormalities, even with a video-assisted laryngoscope.
Other Names:
  • video assisted laryngoscopy with hyper-angulated blade

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Successful intubation
Time Frame: During the period of intubation (as soon as the laryngoscope blade passes the teeth row of the patient until the first capnographic end-expiratory carbon dioxide [CO2] detection is possible)
The primary endpoint is the successful intubation at first attempt as a dichotomous (successful/unsuccessful) event. The first attempt begins with the laryngoscope spatula passing the patient's row of teeth. The attempt is considered unsuccessful if a complete retraction of the laryngoscope or the endotracheal tube from the oropharynx is necessary for any reason (need for bag ventilation, change of device, change of patient position, change in the curvature of the stylet, etc.). Maneuvers that can be performed during laryngoscopy, such as BURP (backward, upward, rightward pressure) or reclining the head, which end with successful intubation, count towards the first attempt.
During the period of intubation (as soon as the laryngoscope blade passes the teeth row of the patient until the first capnographic end-expiratory carbon dioxide [CO2] detection is possible)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Parameters regarding the duration of the intervention
Time Frame: During the period of intubation (as soon as the laryngoscope blade passes the teeth row of the patient until the first capnographic end-expiratory CO2 detection is possible)
Time to intubation and time to glottis view (as announced by the anesthesist)
During the period of intubation (as soon as the laryngoscope blade passes the teeth row of the patient until the first capnographic end-expiratory CO2 detection is possible)
Cormack & Lehane grade
Time Frame: During the period of intubation (as soon as the laryngoscope blade passes the teeth row of the patient until the first capnographic end-expiratory CO2 detection is possible)
Grade 1 (full view of glottis), Grade 2a (partial view of glottis), Grade 2b (view only of posterior extremity of glottis or arytenoid cartilages), Grade 3 (view of epiglottis, none of the glottis), Grade 4 (neither view of glottis nor epiglottis)
During the period of intubation (as soon as the laryngoscope blade passes the teeth row of the patient until the first capnographic end-expiratory CO2 detection is possible)
Intubation success
Time Frame: During the period of intubation (as soon as the laryngoscope blade passes the teeth row of the patient for the first time until the first capnographic end-expiratory CO2 detection is possible)
Total number of attempts. Number of attempts using the randomized device. Success rate of intubation attempts regarding the respective device.
During the period of intubation (as soon as the laryngoscope blade passes the teeth row of the patient for the first time until the first capnographic end-expiratory CO2 detection is possible)
Influence of the device on human factors during the intervention
Time Frame: During the period of intubation and maintenance of anesthesia
Mayo High Performance Teamwork Scale, NASA-TLX (National Aeronautics and Space Administration's Task Load Index)
During the period of intubation and maintenance of anesthesia
Complications: occurrence of one or more of the following
Time Frame: During the period of intubation (as soon as the laryngoscope blade passes the teeth row of the patient for the first time until the first capnographic end-expiratory CO2 detection is possible)
Drop of SpO2 (oxygen saturation) below 90%. Regurgitation as announced by the anesthetist. Need for bronchoscopy due to suspected aspiration. Dental injury or dental clicks upon contact with the blade. Soft tissue injuries as detected by blood on the blade. Visible swelling. Bleeding or other injury of the lips. Need for resuscitation (administration of adrenalin, chest compressions, defibrillation or any combination thereof). Death. Occurence of any adverse event (AE) or serious adverse event (SAE).
During the period of intubation (as soon as the laryngoscope blade passes the teeth row of the patient for the first time until the first capnographic end-expiratory CO2 detection is possible)
Need for auxiliary devices or switch of laryngoscopy device
Time Frame: During the period of intubation (as soon as the laryngoscope blade passes the teeth row of the patient for the first time until the first capnographic end-expiratory CO2 detection is possible)
Manœuvres to optimize intubation conditions after the first attempt at intubation has started. Switch to alternate laryngoscopy device. Switch of the anesthetists. Switch of airway device
During the period of intubation (as soon as the laryngoscope blade passes the teeth row of the patient for the first time until the first capnographic end-expiratory CO2 detection is possible)
Relevant vital parameters during the intervention
Time Frame: During the period of intubation (as soon as the laryngoscope blade passes the teeth row of the patient for the first time until the first capnographic end-expiratory CO2 detection is possible)
Baseline SpO2 and lowest SpO2
During the period of intubation (as soon as the laryngoscope blade passes the teeth row of the patient for the first time until the first capnographic end-expiratory CO2 detection is possible)
Post-operative sore throat, coughing or hoarseness
Time Frame: End of surgery until two hours after the end of surgery
Post-operative sore throat, coughing or hoarseness, according to the "Scoring System for Sore Throat, Cough, and Hoarseness" by Park et al. This outcome will not be assessed in patients who continue to be invasively ventilated > 2 hours after surgery.
End of surgery until two hours after the end of surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Wuerzburg University Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University Hospital, Bonn
University Hospital, Aachen

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Benedikt Schmid, MD, PhD, Department of Anaesthesiology, Medical Faculty Würzburg

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 28, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 17, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 18, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 7, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 7, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 8, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 3, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 31, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • COVALENT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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