Voice AlterationNCT04011111
Intubation Tube Applications on Voice Performance in Early Postoperative Period
An observational study of Voice Alteration and Intubation Complication, run by Hitit University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Voice Alteration, Intubation Complication
- What is being tested?
- Intubation tube and voice analysis
- Type of treatment
- Surgery or procedure
- How many people
- 88 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Jan 2019to 31 Mar 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Adult, Older adult
Study population: Male and female adults
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Hitit University Faculty of Medicine
Çorum, 19100
About this study
Official title: Objective and Subjective Evaluations of the Effect of Different Types of Intubation Tube Applications on Voice Performance in Early Postoperative Period
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.
Read the detailed description
A total of 88 patients who underwent endotracheal intubation either using a cuffed endotracheal (n = 44) or spiral-embedded cuffed endotracheal (n = 44) tube were included in this study. An endotracheal tube of 7.5 mm was used for female patients and that of 8 mm was used for male patients. A preoperative acoustic voice analysis was performed, and fundamental frequency (F0), jitter%, and shimmer% values were recorded. In addition, voice handicap index-30 (VHI-30) questionnaire was completed by the patients for subjective evaluation. The same procedure was repeated in the first 48 hours postoperatively. The preoperative and postoperative data were statistically compared. In addition, the effect of the type of endotracheal intubation tube on acoustic voice analysis parameters and VHI-30 scores was statistically evaluated.
- Conditions
- Voice Alteration, Intubation Complication
- Being tested
- Intubation tube and voice analysis
- Keywords
- voice, intubation, subjective, objective
- Medical subject headings
- Dysphonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intubation tube and voice analysisProcedure or surgery
After the ıntubation tube application, done voice analysis early postoperative period
What is being measured
The primary outcome is the main question the study is designed to answer.
F0 (Fundemental frequency)
Acustic voice analysis parameter
Measured: Preoperative period
Jitter%
Acustic voice analysis parameter
Measured: Preoperative period
Shimmer%
Acustic voice analysis parameter
Measured: Preoperative period
Voice Handicap Index-30
Subjective voice analysis parameter
Measured: Preoperative period
Secondary outcomes (4)
F0 (Fundemental frequency)
Acustic voice analysis parameter
Measured: Postoperative first 48 hours period
Jitter%
Acustic voice analysis parameter
Measured: Postoperative first 48 hours period
Shimmer%
Acustic voice analysis parameter
Measured: Postoperative first 48 hours period
Voice Handicap Index-30
Subjective voice analysis parameter
Measured: Postoperative first 48 hours period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2019
- Study start20 Jan 2019
- Primary completion22 Feb 2019
- Study completion31 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Voice AlterationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hitit University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Doğan Atan, Hitit University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04011111
- Sponsor's protocol ID
- 2019/109
- Status last verified
- Jul 2019
- First submitted
- 2 Jul 2019
- Last updated
- 8 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Objective and Subjective Evaluations of the Effect of Different Types of Intubation Tube Applications on Voice Performance in Early Postoperative Period
- ClinicalTrials.gov ID
- NCT04011111
- Acronym / sponsor ID
- 2019/109
- Conditions
- Voice Alteration, Intubation Complication
- Keywords
- voice, intubation, subjective, objective
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Hitit UniversityUniversity, hospital or other
- Study start
- 20 Jan 2019 (actual)
- Primary completion
- 22 Feb 2019 (actual)
- Study completion
- 31 Mar 2019 (actual)
- First posted
- 8 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
A total of 88 patients who underwent endotracheal intubation either using a cuffed endotracheal (n = 44) or spiral-embedded cuffed endotracheal (n = 44) tube were included in this study. An endotracheal tube of 7.5 mm was used for female patients and that of 8 mm was used for male patients. A preoperative acoustic voice analysis was performed, and fundamental frequency (F0), jitter%, and shimmer% values were recorded. In addition, voice handicap index-30 (VHI-30) questionnaire was completed by the patients for subjective evaluation. The same procedure was repeated in the first 48 hours postoperatively. The preoperative and postoperative data were statistically compared. In addition, the effect of the type of endotracheal intubation tube on acoustic voice analysis parameters and VHI-30 scores was statistically evaluated.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Male and female adults
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intubation tube and voice analysisAfter the ıntubation tube application, done voice analysis early postoperative period | Procedure or surgery | – |
Primary outcome
F0 (Fundemental frequency)
Time frame: Preoperative period
Acustic voice analysis parameter
Jitter%
Time frame: Preoperative period
Acustic voice analysis parameter
Shimmer%
Time frame: Preoperative period
Acustic voice analysis parameter
Voice Handicap Index-30
Time frame: Preoperative period
Subjective voice analysis parameter
4 secondary outcomes
F0 (Fundemental frequency)
Time frame: Postoperative first 48 hours period
Jitter%
Time frame: Postoperative first 48 hours period
Shimmer%
Time frame: Postoperative first 48 hours period
Voice Handicap Index-30
Time frame: Postoperative first 48 hours period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Voice Alteration and Intubation Complication, run by Hitit University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
F0 (Fundemental frequency) (time frame: Preoperative period). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2019.