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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 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]

None

Universal Trial Number (UTN)

U1111-1226-0591

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Difficult intubation

Difficult airway

Condition category

Condition code

Anaesthesiology

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]

Treatment: Devices

Comparator / control treatment

Macintosh laryngoscope + Bonfils intubation fiberscope is the comparator intervention devices.

Control group

Active

Outcomes

Primary outcome [1]

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]

The time needed to verify the successful intubation process with capnography (i.e.:data-linkage to medical records)

Secondary outcome [1]

'Laryngoscopy time' : time needed to intubate,

Timepoint [1]

The time needed to intubate will accounted with stopwatch till end tidal carbon dioxide seen on the anaesthesia machine.

Secondary outcome [2]

Pressure applied to the tooth.
Observable injury to the tooth will be listed.

Timepoint [2]

The time to checking the tooth injury by observation after verifying the successful intubation.

Secondary outcome [3]

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]

The time after verifying the successful intubation.

Secondary outcome [4]

Laryngoscopic view using the percentage of glottic opening (POGO) score,

Timepoint [4]

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?

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

Accrual to date

Final

Recruitment outside Australia

Country [1]

Turkey

State/province [1]

Konya

Funding & Sponsors

Funding source category [1]

University

Name [1]

Selcuk University

Address [1]

Selcuk University Alaaddin Keykubat Campus, Istanbul Street, Yazir District, Scientific Research Office, Selcuklu, Konya, 42100.

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Selcuk University Medical Faculty Ethics Committee

Ethics committee address [1]

Selcuk University Alaaddin Keykubat Campus, Istanbul Street, Yazir District, Medical Faculty Ethics Committee, Selcuklu, Konya, 42100.

Ethics committee country [1]

Turkey

Date submitted for ethics approval [1]

10/11/2015

Approval date [1]

17/12/2015

Ethics approval number [1]

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

Prof Ozkan Onal

Address

Selcuk University Alaaddin Keykubat Campus, Istanbul Street, Yazir District, Medical Faculty Department of Anesthesiology and Reanimation, Selcuklu, Konya, 42100.

Country

Turkey

Phone

+905059052252

Fax

drozkanonal@selcuk.edu.tr

Contact person for public queries

Name

Ozkan Onal

Address

Selcuk University Alaaddin Keykubat Campus, Istanbul Street, Yazir District, Medical Faculty Department of Anesthesiology and Reanimation, Selcuklu, Konya, 42100.

Country

Turkey

Phone

+905059052252

Fax

drozkanonal@selcuk.edu.tr

Contact person for scientific queries

Name

Ozkan Onal

Address

Selcuk University Alaaddin Keykubat Campus, Istanbul Street, Yazir District, Medical Faculty Department of Anesthesiology and Reanimation, Selcuklu, Konya, 42100.

Country

Turkey

Phone

+905059052252

Fax

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.	Type	Citation	Link	Email	Other Details	Attachment
906	Ethical 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

Source	Title	Year of Publication	DOI
Embase	A comparative randomized trial of intubation success in difficult intubation cases: The use of a Frova intubation catheter versus a Bonfils intubation fiberoscope.	2019	https://dx.doi.org/10.5114/wiitm.2019.83610

N.B. These documents automatically identified may not have been verified by the study sponsor.

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