Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001788268
Ethics application status
Approved
Date submitted
16/10/2018
Date registered
1/11/2018
Date last updated
1/11/2018
Date data sharing statement initially provided
1/11/2018
Date results information initially provided
1/11/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Randomized Controlled Trial Comparing the Frova Intubation Catheter with the McGrath Videolaryngoscope in Intubating Adult Patients with Difficult Airways
Scientific title
Randomized clinical trial compared Frova intubation catheter and McGrath videolaryngoscope according to the ratio of successful intubation at the primary attempt in difficult intubation adult patients
Secondary ID [1] 296350 0
'None'
Universal Trial Number (UTN)
U1111-1222-4272
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
difficult intubation 310073 0
airway management 310074 0
Condition category
Condition code
Anaesthesiology 308825 308825 0 0
Other anaesthesiology
Emergency medicine 308826 308826 0 0
Other emergency care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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 F) or the McGrath VL (Group V). 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] 312682 0
Treatment: Devices
Comparator / control treatment
Macintosh laryngoscope + McGrath Videolaryngoscope is the comparator intervention devices.
Control group
Active

Outcomes
Primary outcome [1] 307801 0
The primary outcome was the rate of successful intubation at the first attempt using the frova intubation catheter and Mc Grath videolaryngoscope.
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] 307801 0
The time needed to verify the successful intubation process with capnography (i.e.:data-linkage to medical records)
Secondary outcome [1] 352960 0
'Laryngoscopy time' : time needed to intubate,
Timepoint [1] 352960 0
The time needed to intubate will accounted with stopwatch till end tidal karbondioxide seen on the anaesthesia machine.
Secondary outcome [2] 353170 0
Pressure applied to the tooth.
Observable injury to the tooth will be listed.
Timepoint [2] 353170 0
The time to checking the tooth injury by observation after verifying the successful intubation.
Secondary outcome [3] 353171 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 extubation will be recorded.
Timepoint [3] 353171 0
The time after verifying the successful intubation.
Secondary outcome [4] 353172 0
Laryngoscopic view using the percentage of glottic opening (POGO) score,
Timepoint [4] 353172 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
Treatment
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
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
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
30/01/2015
Date of last participant enrolment
Anticipated
Actual
30/08/2017
Date of last data collection
Anticipated
Actual
30/08/2017
Sample size
Target
50
Accrual to date
Final
49
Recruitment outside Australia
Country [1] 20937 0
Turkey
State/province [1] 20937 0
Selcuklu

Funding & Sponsors
Funding source category [1] 300954 0
University
Name [1] 300954 0
Selcuk University
Country [1] 300954 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] 300590 0
None
Name [1] 300590 0
Address [1] 300590 0
Country [1] 300590 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301720 0
Selcuk University Medical Faculty Ethics Committee
Ethics committee address [1] 301720 0
Selcuk University Alaaddin Keykubat Campus, Istanbul Street, Yazir District, Medical Faculty Ethics Committee, Selcuklu, Konya, 42100.
Ethics committee country [1] 301720 0
Turkey
Date submitted for ethics approval [1] 301720 0
25/12/2014
Approval date [1] 301720 0
06/01/2015
Ethics approval number [1] 301720 0
-050.01.04/

Summary
Brief summary
Difficult airway is one of the main causes of morbidity and mortality in patients who will undergo surgical intervention. Therefore, many devices and algorithms have been developed for the management of difficult airway.
This prospective randomized clinical trial compared two methods of difficult intubation, one using the Frova intubation catheter and the other using a non-channelled McGrath videolaryngoscope.49 patients who have ASA score I-III and who will undergo optional operation under general anesthesia and whom airway management process was difficult cases were involved in the research.
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 3173 3173 0 0
/AnzctrAttachments/376205-convert-jpg-to-pdf.net_2018-10-16_14-41-03.pdf (Ethics approval)
Attachments [2] 3174 3174 0 0
/AnzctrAttachments/376205-ay.pdf (Supplementary information)

Contacts
Principal investigator
Name 87878 0
Prof Ozkan Onal
Address 87878 0
Selcuk University Alaaddin Keykubat Campus, Istanbul Street, Yazir District, Medical Faculty Department of Anesthesiology and Reanimation, Selcuklu, Konya, 42100.
Country 87878 0
Turkey
Phone 87878 0
+905059052252
Fax 87878 0
Email 87878 0
drozkanonal@selcuk.edu.tr
Contact person for public queries
Name 87879 0
Prof Ozkan Onal
Address 87879 0
Selcuk University Alaaddin Keykubat Campus, Istanbul Street, Yazir District, Medical Faculty Department of Anesthesiology and Reanimation, Selcuklu, Konya, 42100.
Country 87879 0
Turkey
Phone 87879 0
+905059052252
Fax 87879 0
Email 87879 0
drozkanonal@selcuk.edu.tr
Contact person for scientific queries
Name 87880 0
Prof Ozkan Onal
Address 87880 0
Selcuk University Alaaddin Keykubat Campus, Istanbul Street, Yazir District, Medical Faculty Department of Anesthesiology and Reanimation, Selcuklu, Konya, 42100.
Country 87880 0
Turkey
Phone 87880 0
+905059052252
Fax 87880 0
Email 87880 0
drozkanonal@selcuk.edu.tr

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
No/undecided IPD sharing reason/comment
We have collected the patients datas and if we have time to input the patients datas' we will input them.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
62Ethical approval    376205-(Uploaded-31-10-2018-20-23-38)-Study-related document.jpg



Results publications and other study-related documents

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

Documents added automatically
No additional documents have been identified.