NCT04247360

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
138

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2020

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2020

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

January 23, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 30, 2020

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2020

Completed
Last Updated

January 31, 2020

Status Verified

January 1, 2020

Enrollment Period

7 months

First QC Date

January 23, 2020

Last Update Submit

January 29, 2020

Conditions

Arthroplasty, Replacement, Hip

Outcome Measures

Primary Outcomes (1)

  • postoperative sore throat

    Number of participants with postoperative sore throat for postoperative 24 hours

    At postoperative 24 hours

Secondary Outcomes (3)

  • postoperative hoarseness

    At postoperative 24 hours

  • nausea

    At postoperative 24 hours

  • Requirements of analgesics

    At postoperative 24 hours

Study Arms (2)

cuff pressure with 20cmH2O

OTHER

continuous monitoring and maintaining cuff pressure with 20 cmH2O during surgery

Device: cuff pressure

cuff pressure with 30cmH2O

OTHER

continuous monitoring and maintaining cuff pressure with 30 cmH2O during surgery

Device: cuff pressure

Interventions

cuff pressureDEVICE

maintaining cuff pressure according the groups

cuff pressure with 20cmH2Ocuff pressure with 30cmH2O

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients undergoing total hip replacement arthroplasty that require general anesthesia

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant professor

Study Record Dates

First Submitted

January 23, 2020

First Posted

January 30, 2020

Study Start

January 1, 2020

Primary Completion

August 1, 2020

Study Completion

August 1, 2020

Last Updated

January 31, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share