Comparison of a conventional method and a new method (use of an automated cuff pressure controller) in the effective sealing cuff pressure.

JRCT ID: jRCT1032210192

Registered date:09/07/2021

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: elective cases under general anesthesia
• Date of first enrollment: 12/07/2021
• Target sample size: 70
• Study type: Interventional
• Intervention(s): Airway invasion by cuff pressure

Outcome(s)

• Primary Outcome: proportion of ventilation leaks around the cuff during positive pressure ventilation with an anesthesia machine after tracheal intubation.
• Secondary Outcome: presence or absence of gas leakage around the cuff.

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1) Patients scheduled to undergo tracheal intubation for general anesthesia surgery
2) Patients with a preoperative ASA Physical Classification System (Class I or II).
Class I: No organic, physiological, biochemical, or psychological abnormalities. The disease to be operated on is localized and does not cause systemic (systematic) damage. The disease to be operated on is localized and does not cause systemic (systematic) damage.
Class II Mild to moderate systematic disorder. The causes are
The cause of the disorder is a disease that has been the subject of surgical treatment, or a condition other than the above, or a physiological cause. Physiological causes.
3) Patients who can give written consent to participate in this study and who are 20 years of age or older at the time of consent.

Exclude criteria

1) Patients undergoing emergency surgery
2) Patients who need to be repositioned
3) Patients who are expected to have difficulty in intubation

Related Information

• Primary Sponsor: Okuda Yasuhisa