Comparison of Endotracheal Intracuff Pressure Between Two Cuff Sealing Methods

DongGuk University

Status: Completed

Conditions: Endotracheal Tube

Treatments: Procedure: MOVT; Procedure: VE/VI ratio of Spirometer

Study type: Interventional

Funder types: Other

Identifiers

NCT03385044

J_In_2017-01

Details and patient eligibility

About

The endotracheal intracuff pressure is to be maintained at a low level to prevent trachea and nerve damages, and yet be high enough to secure air sealing. The objective of the study is to compare minimal occlusive volume technique (MOVT) and expired volume/inspired volume ratio (VE/VI ratio) from a spirometer method of endotracheal tube (ETT) cuff inflation with respect to the cuff pressure required to seal the airway during a laparoscopic surgery under general anesthesia. A study design is a randomized crossover trial in 35 patients. The primary outcome is the intracuff pressure of an endotracheal tube. The study consists of two cuff sealing methods separated by a period of 10 minutes.

Enrollment: 35 patients

Sex: Female

Ages: 20 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• American Society of Anesthesiologists physical status I, II
• Body mass index < 30 kg/m2
• Elective laparoscopic gynecologic surgery under general anesthesia in the Trendelenburg position

Exclusion criteria

• History of airway-related or pulmonary diseases/abnormalities
• When difficult intubation is anticipated
• History of general anesthesia within the past 3 months
• Pregnancy
• History of smoking

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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35 participants in 2 patient groups

Cuff sealing by MOVT

Active Comparator group

Description:

MOVT (minimal occlusive volume technique). The cuff sealing will be confirmed with MOVT, then the intracuff pressure will be measured.

Treatment:

Procedure: MOVT

Cuff sealing by VE/VI ratio

Active Comparator group

Description:

VE/VI ratio of Spirometer. The cuff sealing will be confirmed with VE/VI ratio of a spirometer, then the intracuff pressure will be measured.

Treatment:

Procedure: VE/VI ratio of Spirometer