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Comparison of Endotracheal Intracuff Pressure Between Two Cuff Sealing Methods

NCT ID: NCT03385044

Last Updated: 2018-12-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-12

Study Completion Date

2018-10-29

Brief Summary

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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

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Conditions

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Endotracheal Tube

Keywords

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Endotracheal tube Intracuff pressure Minimal occlusive volume technique Spirometer Endotracheal sealing

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Two methods of cuff sealing will be applied in a random sequence to each patient.
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors
The randomization table of a treatment sequence will be managed by the third person who will not involve in this study.

Study Groups

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Cuff sealing by MOVT

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

Group Type ACTIVE_COMPARATOR

MOVT

Intervention Type PROCEDURE

ETT cuff will be inflated till the disappearance of audible air leak on auscultation, while abdominal carbon dioxide (CO2) inflation is maintained with peak inspiratory pressure of 25 cm H2O during volume controlled ventilation. The patient will be in the Trendelenburg position.

Cuff sealing by VE/VI ratio

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.

Group Type ACTIVE_COMPARATOR

VE/VI ratio of Spirometer

Intervention Type PROCEDURE

ETT cuff will be inflated till the VE/VI ratio meets the initial VE/VI ratio, while abdominal CO2 inflation is maintained with peak inspiratory pressure of 25 cm H2O during volume controlled ventilation. The patient will be in the Trendelenburg position.

Interventions

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MOVT

ETT cuff will be inflated till the disappearance of audible air leak on auscultation, while abdominal carbon dioxide (CO2) inflation is maintained with peak inspiratory pressure of 25 cm H2O during volume controlled ventilation. The patient will be in the Trendelenburg position.

Intervention Type PROCEDURE

VE/VI ratio of Spirometer

ETT cuff will be inflated till the VE/VI ratio meets the initial VE/VI ratio, while abdominal CO2 inflation is maintained with peak inspiratory pressure of 25 cm H2O during volume controlled ventilation. The patient will be in the Trendelenburg position.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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DongGuk University

OTHER

Sponsor Role lead

Responsible Party

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Junyong In, MD, PhD

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Junyong In, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

DongGuk University

Locations

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Dept. of anesthesiology and pain medicine, Dongguk University Ilsan Hospital

Goyang, Gyeonggido, South Korea

Site Status

Countries

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South Korea

Other Identifiers

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J_In_2017-01

Identifier Type: -

Identifier Source: org_study_id