NCT04184778

Brief Summary

How tube size affect patient's experience of postoperative sore throat and hoarseness

Trial Health

87
On Track

Trial Health Score

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

Enrollment
261

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2019

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

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

February 1, 2019

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 10, 2019

Completed
8 months until next milestone

First Posted

Study publicly available on registry

December 4, 2019

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

June 10, 2021

Status Verified

June 1, 2021

Enrollment Period

1.9 years

First QC Date

April 10, 2019

Last Update Submit

June 7, 2021

Conditions

Sore ThroatHoarseness

Keywords

postoperativeTube sizePatient experience

Outcome Measures

Primary Outcomes (2)

  • Sore throat after intubation

    Survey - experienced postoperative sore throat after intubation. A scale from 1-4 is used; 1 indicated no sore throat and 4 indicated seriously sore throat.

    7 days

  • Hoarseness after intubation

    Survey - experienced postoperative hoarseness after intubation. A scale from 1-4 is used; 1 indicated no hoarseness and 4 indicated seriously hoarseness.

    7 days

Study Arms (4)

Woman tube size 6.0

EXPERIMENTAL

Smaller tube than normal

Device: Smaller tube size

Woman tube size 7.0

NO INTERVENTION

Usual tube size

Man tube size 7.0

EXPERIMENTAL

Smaller tube than normal

Device: Smaller tube size

Man tube size 8.0

NO INTERVENTION

Usual tube size

Interventions

Smaller tube sizeDEVICE

Comparing how tube size affect patient's experience of postoperative sore throat and hoarseness in men and women.

Man tube size 7.0Woman tube size 6.0

Eligibility Criteria

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

You may qualify if:

  • Need for intubation
  • Elective surgery
  • ASA Group I and II
  • Understands and speaks Danish
  • give one's consent

You may not qualify if:

  • Known dementia
  • SARI score \>4
  • BMI \> 35
  • Acute intubation
  • attempt intubation \> 2
  • known with previously difficult intubation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

North Denmark Regional Hospital

Hjørring, 9800, Denmark

Location

Aalborg University Hospital

Thisted, 7700, Denmark

Location

MeSH Terms

Conditions

PharyngitisHoarseness

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsPharyngeal DiseasesStomatognathic DiseasesRespiratory Tract DiseasesOtorhinolaryngologic DiseasesVoice DisordersLaryngeal DiseasesRespiration DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsSigns and Symptoms, Respiratory

Study Officials

  • Dorte M Kristensen, PhD

    Regionshospital Nordjylland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

April 10, 2019

First Posted

December 4, 2019

Study Start

February 1, 2019

Primary Completion

December 31, 2020

Study Completion

December 31, 2020

Last Updated

June 10, 2021

Record last verified: 2021-06

Locations

DK(2)