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Completed

NCT Number: NCT04184778

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

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

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Key information

Conditions

Sore Throat Hoarseness Infections Laryngeal Diseases Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Pharyngeal Diseases Pharyngitis Respiration Disorders Respiratory Tract Diseases Respiratory Tract Infections Signs and Symptoms Signs and Symptoms, Respiratory Stomatognathic Diseases Voice Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

North Denmark Regional Hospital, Hjørring, Denmark

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Smaller tube size

Device

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

Primary outcomes

  1. Sore throat after intubation

    Time frame: 7 days

    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.

  2. Hoarseness after intubation

    Time frame: 7 days

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

Sponsors and collaborators

Lead sponsor

Regionshospital Nordjylland

Other Gov

Registry information

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Dec 4, 2019
Registry last updated
Jun 10, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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