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Effect of Cuff Pressure During Operation on Postoperative Sore Throat

NCT ID: NCT04247360

Last Updated: 2020-01-31

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

138 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-31

Study Completion Date

2020-08-31

Brief Summary

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When general anesthesia is performed for surgery, tracheal intubation is performed. In order to ventilate after performing tracheal intubation, air is injected into the cuff attached to the tube to fill the gap between the tracheal tube and the patients's inner surface of trachea.

Even though, 20 to 30 cm H2O is known to be the appropriate pressure to prevent air leaks while preventing ischemic damage of tracheal mucosa. So, Researchers want to observe clinical differences in pressure at both ends of the safety zone of the cuff pressure.

Detailed Description

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Patients who are scheduled for elective surgery/ general anesthesia are randomized to two groups.

l : cuff pressure - 20cmH2O ll : cuff pressure - 30cmH2O

After tracheal intubation with routine method, cuff pressure is continuously monitored with manometer. The anesthesia during surgery is maintained with 0.8 MAC of desflurane and continuous remifentanil. Clinical outcomes (sore throat, hoarseness and postoperative pain) are evaluated after 0 minutes, 2 hours, 4 hours, and 24 hours after surgery.

Conditions

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Arthroplasty, Replacement, Hip

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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cuff pressure with 20cmH2O

continuous monitoring and maintaining cuff pressure with 20 cmH2O during surgery

Group Type OTHER

cuff pressure

Intervention Type DEVICE

maintaining cuff pressure according the groups

cuff pressure with 30cmH2O

continuous monitoring and maintaining cuff pressure with 30 cmH2O during surgery

Group Type OTHER

cuff pressure

Intervention Type DEVICE

maintaining cuff pressure according the groups

Interventions

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cuff pressure

maintaining cuff pressure according the groups

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* patients undergoing total hip replacement arthroplasty that require general anesthesia

Exclusion Criteria

* a patient who disagrees with the study
* tracheal stenosis
* operation time \> 3 hours or \< 1 hour 30 minutes
* difficult airway
* drug abuse, alcoholism
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Keimyung University Dongsan Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Jiwon Lee

assistant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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2018-09-030

Identifier Type: -

Identifier Source: org_study_id