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OpenTrials
Completed

NCT Number: NCT05044416

VieScope in Patients With an Expected Difficult Airway

Patients requiring endotracheal intubation for elective surgery with an expected difficult airway are randomized to be intubated either by a) VieScope or b) videolaryngoscopy.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universitätsklinikum Hamburg-Eppendorf

Hamburg, Free and Hanseatic City of Hamburg, 20246, Germany

About this study

Tracheal intubation is required for different surgical procedures for mechanical ventilation and to prevent aspiration of secretions. In patients with an expected difficult airway, tracheal intubation is often performed by videolaryngoscopy (VL). However, this technique has limitations and may fail due to insufficient visualization of the larynx. A new device has been introduced that consists of an illuminated straight plastic tube for laryngoscopy (VSC, Vie Scope, Adroit Surgical, Oklahoma City, OK, USA) that enables for indirect intubation over a stylet.

So far, the VSC has shown promising results in manikin studies for intubation in normal and difficult airways. We aim to test the VSC in patients compared to videolaryngoscopy in a prospective randomized non-inferiority trial.

Patients will be assessed for eligibility in the Anesthesiology Pre-assessment Clinic of the University Medical Center Hamburg-Eppendorf prior to elective surgery. All patients receive a structured preoperative airway assessment.

Patients are randomized 1:1 to either intervention or control group. Patients randomized to the intervention group will be intubated with the VSC. Patients randomized to the control group are intubated with a MacIntosh type videolaryngoscope (CMAC, Storz, Germany).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients requiring general anesthesia with transoral tracheal intubation for elective surgery
  • Age ≥ 18
  • Preoperative airway assessment reveals an expected difficult airway (rated by the responsible anesthetist in the Pre-assessment Clinic based on the existing in-house algorithm)

Exclusion criteria

  • Pregnant or breastfeeding woman
  • Confirmed indications for awake fiberoptic intubation especially due to enoral, pharyngeal tumors, abscesses or other processes
  • Planned endotracheal intubation without deep anesthesia or neuromuscular blocking agents (e.g. awake videolaryngoscopy)
  • Required transnasal tracheal intubation (e.g. for surgical reasons)
  • Requirement of special endotracheal tubes such as laser or RAE tubes for surgical reasons
  • Patients at risk for pulmonary aspiration who qualify for rapid sequence induction
  • Loose teeth
  • Denial of consent

Treatment and study plan

VieScope

Device

intubation with VieScope laryngoscope

videolaryngoscopy

Device

intubation with videolaryngoscope

Primary outcomes

  1. Percentage of Glottis Opening (POGO) scale

    Time frame: 15 min

    intubating conditions according to the percentage of glottis opening scale (POGO), range 0-100%, higher values better

Secondary outcomes

  1. first attempt success rate

    Time frame: 15 min

    percentage of successful intubations with one attempt

  2. time to intubation

    Time frame: 15 min

    time until tracheal airway access is established

  3. Cormack-Lehane

    Time frame: 15 min

    intubating conditions according to Cormack-Lehane

  4. overall success rate

    Time frame: 15 min

    percentage of successful intubations with the allocated procedure

  5. time to successful intubation with one attempt

    Time frame: 15 min

    time until tracheal airway access is established in patients that are intubated at first attempt

  6. intubation difficulty

    Time frame: 15 min

    subjective rating on a visual analogue scale (0-100, higher values indicate more difficult intubation) of the difficulty of airway management and questionnaire

  7. number of attempts

    Time frame: 15 min

    total number of attempts until airway established

  8. aspiration

    Time frame: 15 min

    percentage of patients that vomit and aspirate during intubation

  9. esophageal intubation

    Time frame: 15 min

    percentage of accidental esophageal intubation attempts

  10. hypoxia

    Time frame: 15 min

    percentage of patients with a desaturation below a pulsoximetric saturation of 80%

  11. hypotension

    Time frame: 15 min

    percentage of patients with a systolic blood pressure below 70 mmHg

Sponsors and collaborators

Lead sponsor

Universitätsklinikum Hamburg-Eppendorf

Other

Registry information

Official study title

Tracheal Intubation With VieScope Versus Videolaryngoscopy in Patients for Elective Surgery With an Expected Difficult Airway - a Prospective Randomized Trial (VieScOP-II)

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Sep 14, 2021
Registry last updated
Jul 1, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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