NCT04011111

Brief Summary

Changes in voice performance in the postoperative period due to trauma suffered during endotracheal intubation or edema occurring in the postoperative period are often observed. The present study aimed to evaluate the effect of different types of intubation tube applications on voice performance in the early postoperative period using objective and subjective voice analysis methods.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
88

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

January 20, 2019

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 22, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2019

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 2, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 8, 2019

Completed
Last Updated

July 8, 2019

Status Verified

July 1, 2019

Enrollment Period

1 month

First QC Date

July 2, 2019

Last Update Submit

July 3, 2019

Conditions

Keywords

voiceintubationsubjectiveobjective

Outcome Measures

Primary Outcomes (4)

  • F0 (Fundemental frequency)

    Acustic voice analysis parameter

    Preoperative period

  • Jitter%

    Acustic voice analysis parameter

    Preoperative period

  • Shimmer%

    Acustic voice analysis parameter

    Preoperative period

  • Voice Handicap Index-30

    Subjective voice analysis parameter

    Preoperative period

Secondary Outcomes (4)

  • F0 (Fundemental frequency)

    Postoperative first 48 hours period

  • Jitter%

    Postoperative first 48 hours period

  • Shimmer%

    Postoperative first 48 hours period

  • Voice Handicap Index-30

    Postoperative first 48 hours period

Interventions

After the ıntubation tube application, done voice analysis early postoperative period

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Male and female adults

You may qualify if:

  • Aged 18-80 years
  • Conforming to the ASA I-II class according to the classification of the American Society of -Anesthesiologists (ASA)
  • who were scheduled to undergo surgery that will not last more than 120 minutes

You may not qualify if:

  • Patients with a lung disease
  • Having obesity (BMI \>35 kg.m-2)
  • Pregnant patients
  • Gastroesophageal reflux
  • Suspected of having difficult airway (mouth opening \<2.5 cm, Mallampati score \>2, sternomental distance \<12.5 cm, thyromental distance \<6 cm, neck circumference \>40 cm)
  • A high risk of aspiration pneumonia
  • Using inhaled steroids

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hitit University Faculty of Medicine

Çorum, 19100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Dysphonia

Condition Hierarchy (Ancestors)

Voice DisordersLaryngeal DiseasesRespiratory Tract DiseasesOtorhinolaryngologic DiseasesNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc. Prof.

Study Record Dates

First Submitted

July 2, 2019

First Posted

July 8, 2019

Study Start

January 20, 2019

Primary Completion

February 22, 2019

Study Completion

March 31, 2019

Last Updated

July 8, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

Locations