Effect of Cuff Pressure During Operation on Postoperative Sore Throat

Arthroplasty, Replacement, Hip Clinical Trial

Official title:

Effect of Cuff Pressure During Operation on Postoperative Sore Throat

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04247360
• Other study ID #: 2018-09-030
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 2020
• Est. completion date: August 2020

Study information

• Verified date: January 2020
• Source: Keimyung University Dongsan Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 138
• Est. completion date: August 2020
• Est. primary completion date: August 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthroplasty, Replacement, Hip
• Pharyngitis

Intervention

Device:
• cuff pressure
maintaining cuff pressure according the groups

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Keimyung University Dongsan Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	postoperative sore throat	Number of participants with postoperative sore throat for postoperative 24 hours	At postoperative 24 hours
Secondary	postoperative hoarseness	Number of participants with postoperative hoarseness for postoperative 24 hours	At postoperative 24 hours
Secondary	nausea	Number of participants with postoperative nausea for postoperative 24 hours	At postoperative 24 hours
Secondary	Requirements of analgesics	Number of participants with analgesics use for postoperative 24 hours	At postoperative 24 hours