ClinicalTrials.gg
CompletedNCT04184778Updated Jun 10, 2021

Does Tracheal Tube Size Affect Patient's Experience of Postoperative Sore Throat and Hoarseness

An interventional study of Smaller tube size in Sore Throat and Hoarseness, sponsored by Regionshospital Nordjylland. Completed at 2 sites in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-06-10.

Primary conditionHoarsenessRegistry: PharyngitisReclassifiedWhy we changed it
Registry
Pharyngitis — the first condition term the registry derived for this study.
ClinicalTrials.gg
Hoarseness
Why
  1. The registry often attaches Pharyngitis to studies about something else, and this study's title and listed conditions do not name it.
  2. The study's listed conditions name Hoarseness.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Regionshospital Nordjylland · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
261
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the detailed description

A randomised controlled study studying how tube size affect patient's experience of postoperative sore throat and hoarseness.

The patients are randomised on the basis of gender. Men are randomized to tube size 8.0 (usual) or 7.0. Women are randomized to tube size 7.0 (usual) or 6.0.

02

Conditions studied

  • Sore Throat
  • Hoarseness

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Keywords

  • postoperative
  • Tube size
  • Patient experience
03

In context

Hoarseness Reclassified

52 studies on the registry are indexed under Hoarseness; 9 are open to participants now.

This study's enrollment of 261 is above the median of 108 across 44 interventional studies indexed under Hoarseness.

Browse Hoarseness studies →

Lead sponsor

Regionshospital Nordjylland is the lead sponsor of 18 studies on the registry; 5 are open to participants now.

Compared within Hoarseness, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Pharyngitis. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Known dementia
  • SARI score >4
  • > 35
  • Acute intubation
  • attempt intubation > 2
  • known with previously difficult intubation
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
261 participants (actual)

Study arms

  • Experimental
    Woman tube size 6.0

    Smaller tube than normal

    Device: Smaller tube size

  • No intervention
    Woman tube size 7.0

    Usual tube size

  • Experimental
    Man tube size 7.0

    Smaller tube than normal

    Device: Smaller tube size

  • No intervention
    Man tube size 8.0

    Usual tube size

Interventions

  • DeviceSmaller tube size

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

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 7 days

  2. 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.

    Time frame: 7 days

07

Study locations

2 sites
  • North Denmark Regional Hospital
    Hjørring, 9800, Denmark
  • Aalborg University Hospital
    Thisted, 7700, Denmark
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 10, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04184778
Lead sponsor
Regionshospital Nordjylland
Responsible party
Dorte Melgaard Kristiansen (Associate professor, Regionshospital Nordjylland) — Principal investigator
First posted
Dec 4, 2019
Start date
Feb 1, 2019
Primary completion
Dec 31, 2020
Completion
Dec 31, 2020
Last update
Jun 10, 2021

Study contacts

Dorte M Kristensen, PhD
principal investigator · Regionshospital Nordjylland

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2021. You cannot join it, but the record below documents what was studied.

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