Intubation Tube Applications on Voice Performance in Early Postoperative Period
Objective and Subjective Evaluations of the Effect of Different Types of Intubation Tube Applications on Voice Performance in Early Postoperative Period
1 other identifier
observational
88
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jan 2019
Shorter than P25 for all trials
1 active site
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
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 22, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2019
CompletedFirst Submitted
Initial submission to the registry
July 2, 2019
CompletedFirst Posted
Study publicly available on registry
July 8, 2019
CompletedJuly 8, 2019
July 1, 2019
1 month
July 2, 2019
July 3, 2019
Conditions
Keywords
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
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
- Hitit Universitylead
Study Sites (1)
Hitit University Faculty of Medicine
Çorum, 19100, Turkey (Türkiye)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
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