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Trial registered on ANZCTR


Registration number
ACTRN12613000672752
Ethics application status
Approved
Date submitted
5/06/2013
Date registered
20/06/2013
Date last updated
20/06/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
A Novel Technique for the Assessment of Vocal Cords in the Early Postoperative Period after Thyroid Surgery: Bonfils Intubation Fiberscope
Scientific title
A study on the comparison of the Macintosh laryngoscope and Bonfils Intubation Fiberscope for the evaluation of the vocal cords in the early postoperative period
Secondary ID [1] 282628 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
goiter 289321 0
Condition category
Condition code
Metabolic and Endocrine 289662 289662 0 0
Thyroid disease
Anaesthesiology 289663 289663 0 0
Other anaesthesiology

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
1.Bonfils intubation fiberoscope (karl Storz Co., Tutlingen, Germany) was introduced into clinical practice during the 1980s. It is a rigid, reusable, straight fiberoptic device (40cm in length and 5 mm in diameter), which has a 40 degree curved tip. It includes flexible eyepiece mounted on the handle. Recent studies found that this device was convenient for tracheal intubation in patients with normal airways or in those with predicted airway difficulties. The Macintosh series laryngoscopes are the predominant model of the curved blade types. During laryngoscopy, the tip or “beak” of the blade is compressed into the angle formed by the base of the tongue and the epiglottis (vallecula), indirectly raising the epiglottis. Macintosh laryngoscope is a device that we use routinely in all intubation procedures.
2. This procedure was performed after 3 minutes of thyroid
surgery
3. The duration of the procedure for both devices was 1 minute.
4.The devices were administered to the patients only for one time.
Intervention code [1] 287294 0
Early detection / Screening
Comparator / control treatment
1. The Macintosh series laryngoscopes are the predominant model of the curved blade types. During laryngoscopy, the tip or “beak” of the blade is compressed into the angle formed by the base of the tongue and the epiglottis (vallecula), indirectly raising the epiglottis. Macintosh laryngoscope is a device that we use routinely in all intubation procedures.
2.The devices were used in participants after 3 minutes of thyroid surgery.
3. The duration of the procedure was 1 minute for both of the devices.
4.The devices were administered to the patients only for one time.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 289738 0
1]:The comparison of the evaluating of the vocal cords in the early postoperative period with The Bonfils intubation fiberscope (BIF) and the Macintosh laryngoscope was done with Cormach-Lehane score. The aim of this study is to compare the vocal cord imaging success of macintosh laryngoscope and BIF.
Timepoint [1] 289738 0
[1]: Assessed 3 minutes after the thyroid surgery.
Primary outcome [2] 289832 0
2]:Hemodynamics (blood pressure and heart rate were recorded by noninvasive techniques)
Timepoint [2] 289832 0
[2]: Assessed 3 minutes after the thyroid surgery.
Primary outcome [3] 289833 0
[3]: Comfort of the patient using with patient reactivity score
Timepoint [3] 289833 0
[3]: Assessed 3 minutes after the thyroid surgery.
Secondary outcome [1] 303152 0
[1]:Adverse events of the laryngoscopy procedure (the percentage of the adverse events were recorded. heart rate level below 50 per minute was recorded as bradycardia. The percentage of retching, damage to teeth and lips were also recorded).
Timepoint [1] 303152 0
[1]: Assessed 3 minutes after the thyroid surgery.
Secondary outcome [2] 303342 0
[2]: Adverse events of the thyroid surgery (Cormach-Lehane score was used for evaluation of adverse events of tyhroid surgery)
Timepoint [2] 303342 0
(2): Assessed 3 minutes after the thyroid surgery.

Eligibility
Key inclusion criteria
50 euthyroid patients aged 18-73 years (ASA I-II) undergoing elective thyroid surgery were included in the study
Minimum age
18 Years
Maximum age
73 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with cardiopulmonary diseases, such as hypertension, coronary artery disease, bronchitis, or asthma, and those with obstructive-sleep apnea syndrome or previous vocal cord dysfunction and difficult intubation were excluded

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis
Preliminary estimation was made for sample size calculation. In extubation period percentage of Cormack-Lehane scoring grade I was %10 for Macintosh laryngoscope, while it was %50 for BIF. For an alpha of 0.05 and a power of at least %80, this magnitude of effect could be demonstrated in a study with 15 patients for each group.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
14/05/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment outside Australia
Country [1] 5127 0
Turkey
State/province [1] 5127 0
Hatay

Funding & Sponsors
Funding source category [1] 287406 0
University
Name [1] 287406 0
Mustafa Kemal University
Country [1] 287406 0
Turkey
Primary sponsor type
University
Name
Mustafa Kemal University
Address
Department of Anesthesiology, Faculty of Medicine, Mustafa Kemal University. Serinyol, Antakya, Hatay. 31034.
Country
Turkey
Secondary sponsor category [1] 286148 0
None
Name [1] 286148 0
Address [1] 286148 0
Country [1] 286148 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289419 0
Ethical Committee Gaziantep University
Ethics committee address [1] 289419 0
Gaziantep Universitesi Tip Fakultesi Dekanligi Arka Bina Kat:2 Sehitkamil, Gaziantep.27310.
Ethics committee country [1] 289419 0
Turkey
Date submitted for ethics approval [1] 289419 0
09/05/2012
Approval date [1] 289419 0
14/05/2012
Ethics approval number [1] 289419 0
14.05.2012/211

Summary
Brief summary
Background: The aim of this study was to compare the imaging success of the Macintosh laryngoscope and the Bonfils intubation fiberscope (BIF) when used to assess the vocal cords in the early postoperative period after thyroid surgery. The patients’ comfort and their hemodynamic responses with the respective techniques were also investigated.
Methods: Fifty euthyroid patients aged 18–73 years (ASA I-II) undergoing elective thyroid surgery were included in the study. In all cases, a Macintosh blade with an appropriate size was used for intubation during the induction of anesthesia. After extubation, the vocal cords were imaged with the Macintosh laryngoscope and the BIF. The Mallampati classification, the thyromental distance, the sternomental distance, the maximum opening of the mouth, and the circumference and mobility of the neck were recorded in the preoperative period. In the postoperative period, the patients’ Cormack–Lehane scores, their reactivity scores, and their hemodynamic parameters with both the Macintosh laryngoscope and the BIF were recorded.
Results: The BIF was significantly more successful in imaging the vocal cords after tracheal extubation than the Macintosh laryngoscope (p=0.000). The patients’ reactivity scores were significantly lower with the BIF when compared to the Macintosh laryngoscope (p=0.000). The mean arterial pressure (MAP) was significantly elevated during Macintosh laryngoscopy compared to Bonfils intubation fiberscopy (p=0.000).
Conclusions: In conclusion, the BIF provided better glottal visualization, less patient discomfort, and fewer hemodynamic responses during the assessment of the vocal cords in the early postoperative period after thyroid surgery when compared to the Macintosh laryngoscope.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 40566 0
Dr Kasim Tuzcu
Address 40566 0
Department of Anesthesiology, Faculty of Medicine, Mustafa Kemal University. Serinyol, Antakya, Hatay. 31034.
Country 40566 0
Turkey
Phone 40566 0
+903262291000
Fax 40566 0
Email 40566 0
[email protected]
Contact person for public queries
Name 40567 0
Dr Kasim Tuzcu
Address 40567 0
Department of Anesthesiology, Faculty of Medicine, Mustafa Kemal University. Serinyol, Antakya, Hatay. 31034.
Country 40567 0
Turkey
Phone 40567 0
+903262291000
Fax 40567 0
Email 40567 0
[email protected]
Contact person for scientific queries
Name 40568 0
Dr Kasim Tuzcu
Address 40568 0
Department of Anesthesiology, Faculty of Medicine, Mustafa Kemal University. Serinyol, Antakya, Hatay. 31034.
Country 40568 0
Turkey
Phone 40568 0
+903262291000
Fax 40568 0
Email 40568 0
[email protected]

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