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Trial registered on ANZCTR


Registration number
ACTRN12619000058178
Ethics application status
Approved
Date submitted
27/12/2018
Date registered
16/01/2019
Date last updated
16/01/2019
Date data sharing statement initially provided
16/01/2019
Date results information initially provided
16/01/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
A comparison of intubation success in difficult intubation cases: The use of a Frova intubation catheter versus a Bonfils intubation fiberoscope
Scientific title
A comparison of intubation success in difficult intubation cases: The use of a Frova intubation catheter versus a Bonfils intubation fiberoscope
Secondary ID [1] 296949 0
None
Universal Trial Number (UTN)
U1111-1226-0591
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Difficult intubation 310905 0
Difficult airway 310906 0
Condition category
Condition code
Anaesthesiology 309571 309571 0 0
Other anaesthesiology

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Bonfils fiberscope (BF) (Karl Storz, Tuttlingen, Germany) is a hard, long, thin device, with a curved end. During intubation, a tracheal tube (TT) is placed in the shaft of the (BF) and inserted into the patient’s mouth. The Frova Intubating Introducer (FC) (Cook U.K. Limited, Letchworth, Hertfordshire, U.K.) was introduced into clinical practice in 1998. The (FC) is a gum flexible bougie and offers improved endotracheal intubation. Its distal tip bends anteriorly at 30°, thereby improving endotracheal biting of the instrument and allowing the instrument to be used with ease and without trauma.
Patients were undergoing elective surgical procedures requiring tracheal intubation, and had been involved in at least one intubation attempt that had been deemed unsuccessful and was performed by an anaesthetist who has at least three years of experience were randomized to tracheal intubation with the Macintosh laryngoscope (size 3 blade in females; size 4 in males) used with the Frova intubation catheter (Group FC) or the Bonfils intubation fiberscope (Group BF). In cases when intubations could not be carried out with the chosen device at the third attempt by an anaesthetist with at least three years of experience, the device was considered to be unsuccessful and intubation was attempted with the second device. When this method also proved unsuccessful, airway management based upon the difficult airway algorithm was maintained. As a third method, the combined use of both devices or intubation with a fibreoptic bronchoscope was preferred.
Intervention code [1] 313218 0
Treatment: Devices
Comparator / control treatment
Macintosh laryngoscope + Bonfils intubation fiberscope is the comparator intervention devices.
Control group
Active

Outcomes
Primary outcome [1] 318527 0
The primary outcome was the rate of successful intubation at the first attempt using the frova intubation catheter and Bonfils intubation fiberscope..
During the intubation attempt whether the chosen device was successful or not will be recorded. The successful intubation process will be verified with capnography when the endotracheal tube place to the lungs.
Timepoint [1] 318527 0
The time needed to verify the successful intubation process with capnography (i.e.:data-linkage to medical records)
Secondary outcome [1] 365251 0
'Laryngoscopy time' : time needed to intubate,
Timepoint [1] 365251 0
The time needed to intubate will accounted with stopwatch till end tidal carbon dioxide seen on the anaesthesia machine.
Secondary outcome [2] 365252 0
Pressure applied to the tooth.
Observable injury to the tooth will be listed.
Timepoint [2] 365252 0
The time to checking the tooth injury by observation after verifying the successful intubation.
Secondary outcome [3] 365253 0
Any complications resulting from intubation.
The smallest arterial oxygen saturation pending or soon afterwards the intubation attempt; the event of little complications (i.e., observable injury to lip or oral mucosa or blood over laryngoscope); or the occurrence of spasm during intubation will be recorded.
Timepoint [3] 365253 0
The time after verifying the successful intubation.
Secondary outcome [4] 365254 0
Laryngoscopic view using the percentage of glottic opening (POGO) score,
Timepoint [4] 365254 0
The time to evaluate by observation after verifying the successful intubation.

Eligibility
Key inclusion criteria
We studied 50 American Society of Anesthesiologists (ASA) physical status I–III patients, aged 18-65. These cases were undergoing elective surgical procedures requiring tracheal intubation and general anaesthesia, and had been involved in at least one intubation attempt that had been deemed unsuccessful and was performed by an anaesthetist who has at least three years of experience.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients who were pregnant, emergency cases, those younger than 18 years, those who had gastroesophageal reflux and delayed gastric emptying, and patients with severe pulmonary disease were excluded.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The allocation sequence was generated by random number tables, and the allocation concealed in sealed envelopes, which were not opened until patient consent had been obtained.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Data and information obtained in the present research were evaluated handling SPSS (Statistical Package for the Social Sciences, version 17.0). To evaluate the datum, additionally detailed statistical techniques (mean and standard deviation), cross tabulations were used. In the comparison of quantitative data, an independent two-sample t-test, the Mann-Whitney U test, and a chi-square test were employed. All detections were assessed at a 95% confidence interval and a p< 0.05 significance level.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/01/2016
Date of last participant enrolment
Anticipated
Actual
1/11/2017
Date of last data collection
Anticipated
Actual
1/11/2017
Sample size
Target
60
Accrual to date
Final
60
Recruitment outside Australia
Country [1] 21147 0
Turkey
State/province [1] 21147 0
Konya

Funding & Sponsors
Funding source category [1] 301517 0
University
Name [1] 301517 0
Selcuk University
Country [1] 301517 0
Turkey
Primary sponsor type
University
Name
Selcuk University
Address
Selcuk University Alaaddin Keykubat Campus, Istanbul Street, Yazir District, Scientific Research Office, Selcuklu, Konya, 42100.
Country
Turkey
Secondary sponsor category [1] 301347 0
None
Name [1] 301347 0
Address [1] 301347 0
Country [1] 301347 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302259 0
Selcuk University Medical Faculty Ethics Committee
Ethics committee address [1] 302259 0
Selcuk University Alaaddin Keykubat Campus, Istanbul Street, Yazir District, Medical Faculty Ethics Committee, Selcuklu, Konya, 42100.
Ethics committee country [1] 302259 0
Turkey
Date submitted for ethics approval [1] 302259 0
10/11/2015
Approval date [1] 302259 0
17/12/2015
Ethics approval number [1] 302259 0
40209705-050.01.04/526

Summary
Brief summary
A difficult airway is one of the main causes of morbidity and mortality in patients who undergo surgical interventions. Therefore, many devices and algorithms have been developed for the management of a difficult airway.
The aim of this study was to compare the success of two devices, a Frova catheter (FC) and Bonfils fiberoscope (BF), in difficult intubation cases.
Methods: Sixty American Society of Anesthesiologists (ASA) class I–III patients aged 18–65 y who were scheduled for elective surgery under general anesthesia and were considered as difficult intubation cases were included in the study. The patients were randomized into two groups, depending on the device used for intubation, with 30 patients in each group.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 89610 0
Prof Ozkan Onal
Address 89610 0
Selcuk University Alaaddin Keykubat Campus, Istanbul Street, Yazir District, Medical Faculty Department of Anesthesiology and Reanimation, Selcuklu, Konya, 42100.
Country 89610 0
Turkey
Phone 89610 0
+905059052252
Fax 89610 0
Email 89610 0
drozkanonal@selcuk.edu.tr
Contact person for public queries
Name 89611 0
Prof Ozkan Onal
Address 89611 0
Selcuk University Alaaddin Keykubat Campus, Istanbul Street, Yazir District, Medical Faculty Department of Anesthesiology and Reanimation, Selcuklu, Konya, 42100.
Country 89611 0
Turkey
Phone 89611 0
+905059052252
Fax 89611 0
Email 89611 0
drozkanonal@selcuk.edu.tr
Contact person for scientific queries
Name 89612 0
Prof Ozkan Onal
Address 89612 0
Selcuk University Alaaddin Keykubat Campus, Istanbul Street, Yazir District, Medical Faculty Department of Anesthesiology and Reanimation, Selcuklu, Konya, 42100.
Country 89612 0
Turkey
Phone 89612 0
+905059052252
Fax 89612 0
Email 89612 0
drozkanonal@selcuk.edu.tr

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Sex distribution of successful intubation methods, Mean age and BMI in successful intubation methods, Success rate of methods, Comparison of difficult intubation methods between successful intubation methods, Comparison of difficult intubation criteria between successful intubation methods.
When will data be available (start and end dates)?
Immediately following publication, no end date.
Available to whom?
Anyone who wishes to access it.
Available for what types of analyses?
Any purpose.
How or where can data be obtained?
Access subject to approvals by Principal Investigator.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
906Ethical approval    376638-(Uploaded-15-01-2019-18-10-56)-Study-related document.pdf


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseA comparative randomized trial of intubation success in difficult intubation cases: The use of a Frova intubation catheter versus a Bonfils intubation fiberoscope.2019https://dx.doi.org/10.5114/wiitm.2019.83610
N.B. These documents automatically identified may not have been verified by the study sponsor.