Effect of Cuff Pressure During Operation on Postoperative Sore Throat

January 29, 2020 updated by: Jiwon Lee, Keimyung University Dongsan Medical Center

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Anticipated)

138

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: cuff pressure with 20cmH2O
continuous monitoring and maintaining cuff pressure with 20 cmH2O during surgery
Device: cuff pressure
maintaining cuff pressure according the groups
Other: cuff pressure with 30cmH2O
continuous monitoring and maintaining cuff pressure with 30 cmH2O during surgery
Device: cuff pressure
maintaining cuff pressure according the groups

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
postoperative sore throat
Time Frame: At postoperative 24 hours
Number of participants with postoperative sore throat for postoperative 24 hours
At postoperative 24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
postoperative hoarseness
Time Frame: At postoperative 24 hours
Number of participants with postoperative hoarseness for postoperative 24 hours
At postoperative 24 hours
nausea
Time Frame: At postoperative 24 hours
Number of participants with postoperative nausea for postoperative 24 hours
At postoperative 24 hours
Requirements of analgesics
Time Frame: At postoperative 24 hours
Number of participants with analgesics use for postoperative 24 hours
At postoperative 24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Keimyung University Dongsan Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

January 1, 2020

Primary Completion (Anticipated)

August 1, 2020

Study Completion (Anticipated)

August 1, 2020

Study Registration Dates

First Submitted

January 23, 2020

First Submitted That Met QC Criteria

January 28, 2020

First Posted (Actual)

January 30, 2020

Study Record Updates

Last Update Posted (Actual)

January 31, 2020

Last Update Submitted That Met QC Criteria

January 29, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018-09-030

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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