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

NCT04185675 | Unknown

• 1 other identifier: E2019012
• Study Type: interventional
• Target: 300
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Laryngoscopes

Keywords

Visual laryngoscope; Direct laryngoscope; Tracheal intubation time

Outcome Measures

Primary Outcomes (1)

• 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).

Study Arms (3)

Macintosh laryngoscope

ACTIVE COMPARATOR

Device: The laryngoscope used for tracheal intubation under general anesthesia for patients with expected non-difficult airway conditions.

nonadjustable videolaryngoscope

EXPERIMENTAL

Device: The laryngoscope used for tracheal intubation under general anesthesia for patients with expected non-difficult airway conditions.

adjustable videolaryngoscope

EXPERIMENTAL

Device: The laryngoscope used for tracheal intubation under general anesthesia for patients with expected non-difficult airway conditions.

Interventions

The laryngoscope used for tracheal intubation under general anesthesia for patients with expected non-difficult airway conditions. DEVICE

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.

Macintosh laryngoscope; adjustable videolaryngoscope; nonadjustable videolaryngoscope

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Sixth Affiliated Hospital, Sun Yat-sen University: lead

Study Officials

• Sanqing Jin, Doctor

  Sixth Affiliated Hospital, Sun Yat-sen University

  STUDY CHAIR

Central Study Contacts

Yanna Pi, Master

CONTACT

86 18819186153; piyanna@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 30, 2019
• First Posted: December 4, 2019
• Study Start: December 1, 2019
• Primary Completion: March 1, 2020
• Study Completion: March 1, 2020
• Last Updated: December 11, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Not decided yet. We plan to share the above information from the article has been published to six months after publication.
• Access Criteria: Access Criteria has not been decided.