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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04185675
Other study ID # E2019012
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date December 2019
Est. completion date March 2020

Study information

Verified date December 2019
Source Sixth Affiliated Hospital, Sun Yat-sen University
Contact Yanna Pi, Master
Phone 86 18819186153
Email piyanna@126.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 300
Est. completion date March 2020
Est. primary completion date March 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Sixth Affiliated Hospital, Sun Yat-sen University

Outcome

Type Measure Description Time frame Safety issue
Primary 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).
See also
  Status Clinical Trial Phase
Completed NCT04994652 - Video- Or Direct Laryngoscopy for Endotracheal Intubation in Newborns N/A
Completed NCT03841890 - The Clarus Video System and Direct Laryngoscope for Rapid Sequence Induction Intubation With Cricoid Pressure N/A
Completed NCT02033564 - Incidence of Sore Throat With Traditional Intubation Blades or Glidescope Blade N/A