Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCRB00587

2 Trial Registration Date

2018-02-28

i Registration Status

Prospective

3 Secondary IDs

EC ref:17033

4 Source(s) of Funding

Departmental resources

5 Primary Sponsor

Departmental resources

6 Secondary Sponsor

N/A

Function

Not Applicable

Please specify

7 Responsible Contact Person (public contact person for patients interested in participating)

i Name

Dr Carmen Lam

ii Address

OT5, Main Block, Tuen Mun Hospital, Tsing Ching Koon Road, Tuen Mun, NT, HK

iii Phone

90804633

iv Email

carmenlam1013@gmail.com

v Affiliation

Anaesthesia and Intensive Care

vi Country

Hong Kong

8 Research Contact Person (person to contact for scientific inquiries)

i Name

Carmen Lam

ii Address

OT5, Main Block, Tuen Mun Hospital, Tsing Ching Koon Road, Tuen Mun, NT, HK

iii Phone

90804633

iv Email

carmenlam1013@gmail.com

v Affiliation

Anaesthesia and Intensve Care

vi Country

Hong Kong

9 Official Scientific Title of the Study

A pilot trial comparing the first-pass intubation success of the Airtraqlaryngoscope versus the Macintosh direct laryngoscope in patients requiringgeneral anaesthesia for elective operation.

10 Public Title

A pilot trial comparing the first-pass intubation success of the Airtraqlaryngoscope versus the Macintosh direct laryngoscope in patients requiringgeneral anaesthesia for elective operation.

i Public Title in Chinese 研究名稱

比較在全身麻醉期間使用Airtraq視頻喉鏡相對於Macintosh直視喉鏡作為氣管插管的一次性成功率的初步對照研究”

11 Short Title (Optional)

Airtraq vs Mac Trial

12 Countries of Recruitment

Hong Kong

13 Research Ethic Review

i Has the study received appropriate ethics approval?

Yes

ii When is the approval date?

2017-06-30

iii Full Name of IRB/IEC

New Territories West Cluster Research Ethics Committee

Please specify

iv IRB/IEC approval reference number

NTWC/CREC/17033

14 Medical Condition Being Studied

Intubation condition

15 Intervention

i Types of intervention

Device

Please specify

ii Description/ name of Intervention/article

Study on the first attempt successful rate in intubation using Airtraq laryngoscope

iii Dosage form of the intervention

No of intubation attempts

iv Dosage of the intervention

NA

v Duration of the intervention

NA

vi Frequency of the intervention

NA

16 Comparative Treatments

i Description/ name of comparative treatments

Study on the first attempt successful rate in intubation using Machitosh laryngoscope

ii Dosage form of the comparative treatments

No of intubation attempts

iii Dosage of the comparative treatments

NA

iv Duration of the comparative treatments

NA

v Frequency of the comparative treatments

NA

17 Key Inclusion and Exclusion Criteria

i Inclusion Criteria

Adult >=18 years old

Receiving general Anaesthesia requiring intubation

ii Exclusion Criteria

Known or predicted difficult bad-mask ventilation

Patient scheduled for awake or asleep fibreoptic intibation

Patient requiring rapid sequence intubation

Language or cognitive barrier that precludes patient from an adequate informed consent

Patient’s or snesthetist’s refusal

iii Age Minimum

18

iv Age Maximum

999

v Gender

Both Male and Female

18 Study Type

Interventional

19 Study Design

i Randomization

Randomized

Please specify

Computer randomization

ii Nature of control

Dose comparison

iii Degree of masking

Open label

If Single-blind, who will be masked?

iv Group Assignment

Parallel

v Study Phase

Other

Please specify

Pilot

vi Study Objectives (Optional)

Therefore, this pilot study aims to examine the feasibility of a large multicentre effectiveness trial by assessing recruitment targets, testing the data completeness, and local incidence of first-pass intubation success.

20 Anticipated trial start date

2018-03-06

21 Target Sample Size

360

22 Recruitment Status

Not Yet Recruiting

23 Primary Outcome

i The Name of the outcome

Study feadilibility

ii The metric or method of measurement used

Feasibility Endpoints: 1. 90% successful recruitment rate 2. 95% data completeness 3. 95% adherence to group assignation

iii The timepoint(s) of primary interest

24 Secondary Outcome

i The Name of the outcome

local incidence of first-pass success rate

ii The metric or method of measurement used

No of first-pass success/ total no of subjects recruited

iii The timepoint(s) of primary interest

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2021-02-05

27 Primary Registry and Trial Identifying Number

ChiCTR1800015046

28 Date of Registration in Primary Registry

2018-02-28

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Trial History Detail on 2019-03-22