NCT03693417

Brief Summary

This investigation is planned to compare the incidence and severity of postoperative sore throat according to the use of heated breathing circuit in patients undergoing endotracheal intubation for general anesthesia.

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
92

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2018

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 1, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 3, 2018

Completed
29 days until next milestone

Study Start

First participant enrolled

November 1, 2018

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2019

Completed
Last Updated

October 3, 2018

Status Verified

October 1, 2018

Enrollment Period

1 year

First QC Date

October 1, 2018

Last Update Submit

October 1, 2018

Conditions

General Anesthesia

Keywords

pharyngitisintubationheat

Outcome Measures

Primary Outcomes (1)

  • Number of participants with postoperative sore throat for postoperative 24 hour

    At 24 hour

Secondary Outcomes (3)

  • Number of participants with postoperative sore throat

    At 2, 4, and 24 hour

  • Number of participants with postoperative hoarseness

    At 2, 4, and 24 hour

  • Wound pain scores

    At 2, 4, and 24 hour

Study Arms (2)

Control

ACTIVE COMPARATOR
Device: Heated circuit off

Heat

EXPERIMENTAL
Device: Heated circuit on

Interventions

Heated circuit onDEVICE

Heated circuit will be turned on.

Heat
Heated circuit offDEVICE

Heated circuit will be turned off.

Control

Eligibility Criteria

Age19 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ASA I-III
  • Patients scheduled for general anesthesia with endotracheal intubation

You may not qualify if:

  • Difficult airway
  • Mallampatti scores greater than 2
  • Recent sore throat
  • Cervical spine disease
  • Recent upper respiratory infection
  • Recent analgesics
  • History of head and neck surgery
  • Friable teeth
  • Multiple intubation attempts

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pharyngitis

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsPharyngeal DiseasesStomatognathic DiseasesRespiratory Tract DiseasesOtorhinolaryngologic Diseases

Central Study Contacts

Hyun-Chang Kim

CONTACT

+821028862876onidori1979@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

October 1, 2018

First Posted

October 3, 2018

Study Start

November 1, 2018

Primary Completion

November 1, 2019

Study Completion

November 1, 2019

Last Updated

October 3, 2018

Record last verified: 2018-10