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Completed

NCT Number: NCT06149338

The Rate of Successful Intubation and the Required Time for Intubation, Using Vie Scope and Macintosh Laryngoscope Will be Compared, in Order to Evaluate the Efficacy of Vie Scope in Comparison With Macintosh in Expected Easy Airways.

The rate of successful intubation and the required time for intubation, using Vie Scope and Macintosh Laryngoscope will be compared, in order to evaluate the efficacy of Vie Scope in comparison with Macintosh in expected easy airways. Hence, a prospective randomized controlled single-blind superiority clinical trial will be conducted.

Inclusion criteria: patients of both sexes, positive or negative rapid test for COVID-19 or possible contamination, age ≥18 years old, BMI: 18.5 - 30 kg/m2, visualization of the glottis grade 1 or 2, according to Cormack-Lehane Classification.

Exclusion criteria: age under 18 years old, BMI under 18.5 kg/m2 and BMI over 30 kg/m2, visualization of the glottis grade 3 - 4, according to Cormack-Lehane Classification.

The laryngoscopy and intubation of the patients will be attempted by the same person-resident of Anesthesiology, under the supervision of experienced Anesthesiologist consultants.

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Key information

Conditions

Laryngoscopy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Saint Andrew's General Hospital of Patras

Pátrai, 263 32, Greece

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Patients of both sexes
  • Positive or negative rapid test for COVID-19 or possible contamination
  • Age ≥18 years old
  • BMI: 18.5 - 30 kg/m2
  • Visualization of the glottis grade 1 or 2, according to Cormack-Lehane Classification.

Exclusion criteria

  • Age under 18 years old
  • BMI under 18.5 kg/m2 and BMI over 30 kg/m2
  • Visualization of the glottis grade 3 - 4, according to Cormack-Lehane Classification.

Treatment and study plan

Macintosh laryngoscope

Device

Macintosh laryngoscope has been the gold standard for endotracheal intubation since the middle of 20th century. During laryngoscopy and direct vision of the vocal cords, an endotracheal tube is passed into the trachea, establishing the airway.

Vie Scope

Device

Vie Scope is a laryngoscope, whose function is relied on Seldinger technique. Firstly, bougie is passed through the translucent barrel of Vie Scope under direct vision between the vocal cords and into the trachea. Then, Vie Scope is removed and an endotracheal tube is passed over the bougie, which will be finally removed. The inflation of the endotracheal tube's cuff is followed by ventilation and confirmation of the tube placement.

Primary outcomes

  1. Rate of Successful Intubation With One Attempt

    Time frame: Evaluation immediately after the first attempt of intubation

    This outcome depends on whether the intubation of each patient will be successful or not, after the first attempt of intubation

  2. Mean Intubation Time

    Time frame: Assessment of the required mean time interval for intubation, immediately after the insertion of laryngoscope's blade into the patient's mouth

    Mean time interval required for intubation, which is determined from the time of the insertion of the laryngoscope into the patient's mouth until the time of the inflation of the tube's cuff on each patient

Secondary outcomes

  1. Rate of Successful Intubation

    Time frame: Evaluation immediately after the intubation attempts

    This outcome depends on whether the intubation of each patient will be successful or not

  2. Visualization of the Glottis, According to Cormack Lehane Classification

    Time frame: This outcome will be evaluated during laryngoscopy and intubation of each patient

    Ability to visualize the glottis, according to Cormack Lehane classification. The specific classification is divided into four grades (1-4). The higher the grade, the higher the likelihood of difficult intubation.

Sponsors and collaborators

Lead sponsor

St. Andrew's General Hospital, Patras, Greece

Other

Registry information

Official study title

Vie Scope Versus Macintosh Laryngoscope in Expected Easy Airways: A Randomized Controlled Trial

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Nov 29, 2023
Registry last updated
Feb 7, 2025

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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