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Effect of Cuff Pressure During Operation on Postoperative Sore Throat

Primary Purpose

Arthroplasty, Replacement, Hip

Status

Unknown status

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

cuff pressure

About this trial

This is an interventional supportive care trial for Arthroplasty, Replacement, Hip

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Arm Label

cuff pressure with 20cmH2O

cuff pressure with 30cmH2O

Arm Description

continuous monitoring and maintaining cuff pressure with 20 cmH2O during surgery

continuous monitoring and maintaining cuff pressure with 30 cmH2O during surgery

Outcomes

Primary Outcome Measures

postoperative sore throat

Number of participants with postoperative sore throat for postoperative 24 hours

Secondary Outcome Measures

postoperative hoarseness

Number of participants with postoperative hoarseness for postoperative 24 hours

nausea

Number of participants with postoperative nausea for postoperative 24 hours

Requirements of analgesics

Number of participants with analgesics use for postoperative 24 hours

Full Information

NCT ID

NCT04247360

First Posted

January 23, 2020

Last Updated

January 29, 2020

Sponsor

Keimyung University Dongsan Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT04247360

Brief Title

Effect of Cuff Pressure During Operation on Postoperative Sore Throat

Official Title

Effect of Cuff Pressure During Operation on Postoperative Sore Throat

Study Type

Interventional

2. Study Status

Record Verification Date

January 2020

Overall Recruitment Status

Unknown status

Study Start Date

January 2020 (Anticipated)

Primary Completion Date

August 2020 (Anticipated)

Study Completion Date

August 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Keimyung University Dongsan Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Arthroplasty, Replacement, Hip

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

138 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

cuff pressure with 20cmH2O

Arm Type

Other

Arm Description

continuous monitoring and maintaining cuff pressure with 20 cmH2O during surgery

Arm Title

cuff pressure with 30cmH2O

Arm Type

Other

Arm Description

continuous monitoring and maintaining cuff pressure with 30 cmH2O during surgery

Intervention Type

Device

Intervention Name(s)

cuff pressure

Intervention Description

maintaining cuff pressure according the groups

Primary Outcome Measure Information:

Title

postoperative sore throat

Description

Number of participants with postoperative sore throat for postoperative 24 hours

Time Frame

At postoperative 24 hours

Secondary Outcome Measure Information:

Title

postoperative hoarseness

Description

Number of participants with postoperative hoarseness for postoperative 24 hours

Time Frame

At postoperative 24 hours

Title

nausea

Description

Number of participants with postoperative nausea for postoperative 24 hours

Time Frame

At postoperative 24 hours

Title

Requirements of analgesics

Description

Number of participants with analgesics use for postoperative 24 hours

Time Frame

At postoperative 24 hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

12. IPD Sharing Statement

Plan to Share IPD

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Effect of Cuff Pressure During Operation on Postoperative Sore Throat

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