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

Comparison between a conventional method and the use of an automated cuff pressure controller device in the effective sealing pressure: a randomized controlled study.

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT1032210192
Enrollment
70
Registered
2021-07-09
Start date
2021-07-12
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

elective cases under general anesthesia The cuff pressure of endotracheal tube

Interventions

Airway invasion by cuff pressure

Sponsors

Okuda Yasuhisa
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion 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.

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
proportion of ventilation leaks around the cuff during positive pressure ventilation with an anesthesia machine after tracheal intubation.

Secondary

MeasureTime frame
presence or absence of gas leakage around the cuff.

Contacts

Public ContactKazuhiro Urabe

Dokkyo Medical University Saitama Medical Center

k-urabe@dokkyomed.ac.jp+81-48-965-1111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026