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

NCT ID: NCT04184778

Last Updated: 2021-06-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

261 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-01

Study Completion Date

2020-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Sore Throat Hoarseness

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Woman tube size 6.0

Smaller tube than normal

Group Type EXPERIMENTAL

Smaller tube size

Intervention Type DEVICE

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

Woman tube size 7.0

Usual tube size

Group Type NO_INTERVENTION

No interventions assigned to this group

Man tube size 7.0

Smaller tube than normal

Group Type EXPERIMENTAL

Smaller tube size

Intervention Type DEVICE

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

Man tube size 8.0

Usual tube size

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Smaller tube size

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Regionshospital Nordjylland

OTHER_GOV

Sponsor Role lead

Responsible Party

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Dorte Melgaard Kristiansen

Associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dorte M Kristensen, PhD

Role: PRINCIPAL_INVESTIGATOR

Regionshospital Nordjylland

Locations

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North Denmark Regional Hospital

Hjørring, , Denmark

Site Status

Aalborg University Hospital

Thisted, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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RHN_DMK_06

Identifier Type: -

Identifier Source: org_study_id

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