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.

Laryngoscopy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06149338
• Other study ID #: 141/09.07.2023
• Status: Recruiting
• Phase: N/A
• Start date: July 26, 2023
• Est. completion date: May 2024

Study information

• Verified date: January 2024
• Source: St. Andrew's General Hospital, Patras, Greece
• Contact: Vasileios Boviatsis, Medical Doctor
• Phone: +306982925945
• Email: billboviatsis[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: May 2024
• Est. primary completion date: May 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Laryngoscopy

Intervention

Device:
• Macintosh laryngoscope
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
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.

Locations

Country	Name	City	State
Greece	Saint Andrew's General Hospital of Patras	Patra

Sponsors (1)

Lead Sponsor	Collaborator
St. Andrew's General Hospital, Patras, Greece

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of successful intubation with one attempt	This outcome depends on whether the intubation of each patient will be successful or not, after the first attempt of intubation	Evaluation immediately after the first attempt of intubation
Primary	Mean intubation time	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	Assessment of the required mean time interval for intubation, immediately after the insertion of laryngoscope's blade into the patient's mouth
Secondary	Rate of successful intubation	This outcome depends on whether the intubation of each patient will be successful or not	Evaluation immediately after the intubation attempts
Secondary	Visualization of the glottis, according to Cormack Lehane classification	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.	This outcome will be evaluated during laryngoscopy and intubation of each patient