Comparison of Endotracheal Intracuff Pressure Between Two Cuff Sealing Methods

Not Applicable

Completed

• Conditions: Endotracheal Tube
• Interventions: Procedure: MOVT; Procedure: VE/VI ratio of Spirometer

• Registration Number: NCT03385044
• Lead Sponsor: DongGuk University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-12-20
• Study First Submitted QC: 2017-12-26
• Study First Posted: 2017-12-28
• Study Start: 2018-03-12
• Primary Completion: 2018-10-29
• Study Completion: 2018-10-29
• Status Verified: 2018-12
• Last Update Submitted: 2018-12-12
• Last Update Posted: 2018-12-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 35

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Cuff sealing by MOVT	MOVT	MOVT (minimal occlusive volume technique). The cuff sealing will be confirmed with MOVT, then the intracuff pressure will be measured.
Cuff sealing by VE/VI ratio	VE/VI ratio of Spirometer	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.

Primary Outcome Measures

Name	Time	Method
Intracuff Pressure	From the start of cuff inflation to the airway sealing, an average of 2 minutes	The intracuff pressure of endotracheal tube when cuff sealing is achieved.

Secondary Outcome Measures

Name	Time	Method
Intracuff air volume	From the start of cuff inflation to the airway sealing, an average of 2 minutes	The intracuff air volume of endotracheal tube when cuff sealing is achieved.

Trial Locations

Locations (1)

Dept. of anesthesiology and pain medicine, Dongguk University Ilsan Hospital; 🇰🇷 Goyang, Gyeonggido, Korea, Republic of