Effect of Cuff Pressure During Operation on Postoperative Sore Throat

Keimyung University

Status: Unknown

Conditions: Arthroplasty, Replacement, Hip

Treatments: Device: cuff pressure

Study type: Interventional

Funder types: Other

Identifiers

NCT04247360

2018-09-030

Details and patient eligibility

About

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.

Full 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.

Enrollment: 138 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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138 participants in 2 patient groups

cuff pressure with 20cmH2O

Other group

Description:

continuous monitoring and maintaining cuff pressure with 20 cmH2O during surgery

Treatment:

Device: cuff pressure

cuff pressure with 30cmH2O

Other group

Description:

continuous monitoring and maintaining cuff pressure with 30 cmH2O during surgery

Treatment:

Device: cuff pressure