Comparison of Two Types of Videolaryngoscope and Direct Laryngoscope in Expected Non-difficult Airway Patients

Macintosh direct laryngoscope has been mostly widely used for anesthesiologists in operation rooms or emergency situations all over the world. With rapidly development of technical devices, nowadays videolaryngoscope has become more and more popular in hospitals, for it could improve first intubation success rate and it is easier for beginners to learn. And there are many different types of videolaryngoscope for different purpose, like with or without a channel, different curvature, and so go. In this study, our aim is to study whether the videolaryngoscope which can be adjustable or not costs less intubation time and causes fewer injury in expected non-difficult airway patients by experienced anesthesiologists, compared with the classic Macintosh direct laryngoscope.

Study Overview

• Status: Unknown
• Conditions: Laryngoscopes
• Intervention / Treatment: Device: The laryngoscope used for tracheal intubation under general anesthesia for patients with expected non-difficult airway conditions.

• Study Type: Interventional
• Enrollment (Anticipated): 300
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yanna Pi, Master; Phone Number: 86 18819186153; Email: piyanna@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• age between18 and 65 years
• ASA(American Society of anesthesiologists) I-II
• BMI 18-30 kg/m2
• scheduled to receive elective surgery under general anesthesia with expected non-difficult airway in operation rooms.

Exclusion Criteria:

• expected difficult airway
• allergy to anesthesia induction drugs
• scheduled to receive surgeries affecting vocalisation
• with high reflux aspiration risk
• with acute and chronic cardiac or respiratory failure
• with glucocorticoids medication history
• with mental disorder or transferred to SICU(Surgical Intensive Care Unit) or ICU after surgery who can not cooperate well with others
• refused or have participated in other clinical trials that may have effects on the outcomes of this study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Macintosh laryngoscope	Device: The laryngoscope used for tracheal intubation under general anesthesia for patients with expected non-difficult airway conditions.; All the patients will receive the same anesthesia induction, and are randomized to three groups to receive different types of laryngoscope for intubation. These are the direct Macintosh laryngoscope, adjustable videolaryngoscope and nonadjustable videolaryngoscope.
EXPERIMENTAL: nonadjustable videolaryngoscope	Device: The laryngoscope used for tracheal intubation under general anesthesia for patients with expected non-difficult airway conditions.; All the patients will receive the same anesthesia induction, and are randomized to three groups to receive different types of laryngoscope for intubation. These are the direct Macintosh laryngoscope, adjustable videolaryngoscope and nonadjustable videolaryngoscope.
EXPERIMENTAL: adjustable videolaryngoscope	Device: The laryngoscope used for tracheal intubation under general anesthesia for patients with expected non-difficult airway conditions.; All the patients will receive the same anesthesia induction, and are randomized to three groups to receive different types of laryngoscope for intubation. These are the direct Macintosh laryngoscope, adjustable videolaryngoscope and nonadjustable videolaryngoscope.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tracheal intubation time	total time to successful orotracheal intubation	time from the removal of the patient's face mask for preoxygenation to confirmation of good tube position based on continuous positive end-tidal carbon dioxide reading (at least three breaths without a significant visual decrease in capnography).

Collaborators and Investigators

• Sponsor: Sixth Affiliated Hospital, Sun Yat-sen University
• Investigators: Study Chair: Sanqing Jin, Doctor, Sixth Affiliated Hospital, Sun Yat-sen University

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): December 1, 2019
• Primary Completion (ANTICIPATED): March 1, 2020
• Study Completion (ANTICIPATED): March 1, 2020

Study Registration Dates

• First Submitted: November 30, 2019
• First Submitted That Met QC Criteria: December 3, 2019
• First Posted (ACTUAL): December 4, 2019

Study Record Updates

• Last Update Posted (ACTUAL): December 11, 2019
• Last Update Submitted That Met QC Criteria: December 8, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Keywords: Direct laryngoscope; Visual laryngoscope; Tracheal intubation time
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics
• Other Study ID Numbers: E2019012

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Time Frame: Not decided yet. We plan to share the above information from the article has been published to six months after publication.
• IPD Sharing Access Criteria: Access Criteria has not been decided.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No