NCT03689127

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 double-lumen endotracheal intubation.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
106

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2018

Geographic Reach
1 country

1 active site

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

September 27, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 28, 2018

Completed
1 month 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

September 28, 2018

Status Verified

September 1, 2018

Enrollment Period

1 year

First QC Date

September 27, 2018

Last Update Submit

September 27, 2018

Conditions

Keywords

intubationpharyngitis

Outcome Measures

Primary Outcomes (1)

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

    At 24 hours

Secondary Outcomes (6)

  • Number of participants with postoperative sore throat

    At 1, 6, and 24 hours

  • Postoperative sore throat scores

    At 1, 6, and 24 hours

  • Number of participants with postoperative hoarseness

    At 1, 6, and 24 hours

  • Number of participants with postoperative shivering

    At 1, 6, and 24 hours

  • Wound pain scores

    At 1, 6, and 24 hours

  • +1 more secondary outcomes

Study Arms (2)

Control

ACTIVE COMPARATOR

Heated breathing circuit will be turned off.

Device: Heated breathing circuit off

Heat

EXPERIMENTAL

Heated breathing circuit will be turned on.

Device: Heated breathing circuit on

Interventions

Heated breathing circuit will be turned on.

Heat

Heated breathing circuit will be turned off.

Control

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ASA I-III
  • Patients scheduled for double-lumen 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

Study Sites (1)

Hyun-Chang Kim

Daegu, Non-US/Canada, 137-040, South Korea

Location

MeSH Terms

Conditions

Pharyngitis

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsPharyngeal DiseasesStomatognathic DiseasesRespiratory Tract DiseasesOtorhinolaryngologic Diseases

Central Study Contacts

Study Design

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

Study Record Dates

First Submitted

September 27, 2018

First Posted

September 28, 2018

Study Start

November 1, 2018

Primary Completion

November 1, 2019

Study Completion

November 1, 2019

Last Updated

September 28, 2018

Record last verified: 2018-09

Locations