Is the McGRATH MAC video laryngoscope useful for intubation of infants by anesthesiology trainees?: a randomized controlled trial

JRCT ID: jRCT1012210051

Registered date:19/11/2021

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Patient undergoing general anesthesia
• Date of first enrollment: 22/11/2021
• Target sample size: 120
• Study type: Interventional
• Intervention(s): Assign the laryngoscope to be used during intubation to a video laryngoscope group that uses a video laryngoscope (McGRATH MAC AO3 video laryngoscope) that provides images of the epiglottis on a screen attached to the device, or a direct-view laryngoscope (Welch-Allen laryngoscope) that directly checks the epiglottis. The assigned laryngoscopes are used at the time of initial intubation and at the time of second intubation.

Outcome(s)

• Primary Outcome: Differences in first-time intubation success rates between direct-view laryngoscopes and video laryngoscopes

Secondary Outcome

1Time required for intubation
2Number of intubations
3Glottal visibility time
4Intubation tube insertion time
5Apnea time
6Glottal visibility score (Cormack classification, POGO score)
7Intubation difficulty score
8Changes in vital signs before and after intubation
9Incidence of disease, etc.

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: < 1age old
• Gender: Both

Include criteria

Patients who will undergo routine non-cardiac surgery with a scheduled duration of 30 minutes or more under general anesthesia at the implementing medical institution participating in this study and who meet the following conditions
(1) Males and females who are less than 1 year of age at the time of obtaining consent
(2) Those who have obtained written consent for participation in this study after receiving sufficient explanation and understanding from a surrogate (a person who is considered to be able to represent the will and interests of the research subject).

Exclude criteria

(1) Patients who will not be intubated orally by an anesthesiologist (cases in which nasal intubation, mask ventilation, and airway maintenance with supraglottic devices are planned)
(2) Patients who are expected to have difficulty in intubation based on physical examination during preoperative consultation (e.g., deformity of the face or airway)
(3) Patients whose weight was less than 3 kg at the time of consent.
(4) Patients with a history of difficult intubation during general anesthesia in the past (more than 3 intubations not for the purpose of tracheal tube replacement, or more than Grade III of the Cormack Classification*1)
(5) If the subject is intubated for the second time or more, the subject is scheduled to be intubated by the same anesthesiologist who performed the intubation in the past.
(6) Cases in which the anesthesiologist cannot be in charge of intubation due to staffing limitations.
(7) Other patients who are judged by the principal investigator to be inappropriate as research subjects.
1 Cormack classification: Grade I: vocal cords can be observed, II: vocal cords can be partially observed, III: vocal cords cannot be observed, but epiglottis can be observed, IV: epiglottis cannot be observed

Related Information

• Primary Sponsor: Fujita Noriaki