Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00296

2 Trial Registration Date

2011-08-12

i Registration Status

Prospective

3 Secondary IDs

2011/08/12

4 Source(s) of Funding

Department funded

5 Primary Sponsor

Dept. of Anesthesia and Intensive Care

6 Secondary Sponsor

N/A

Function

Please specify

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

i Name

Pui-Nga Patricia LEUNG

ii Address

R04C06, Dept. of Anesthesia and Intensive Care, 4/F Mainblock and Trauma Centre, Prince of Wales Hospital, the Chinese university of Hong Kong, Shatin, NT, HKSAR

iii Phone

2632 3155(office)

iv Email

leungyaya@cuhk.edu.hk

v Affiliation

Dept. of Anesthesia and Intensive Care, CUHK

vi Country

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

i Name

Pui-Nga Patricia LEUNG

ii Address

R04C06, Dept. of Anesthesia and Intensive Care, 4/F Mainblock and Trauma Centre, Prince of Wales Hospital, the Chinese university of Hong Kong, Shatin, NT, HKSAR

iii Phone

2632 3155(office)

iv Email

leungyaya@cuhk.edu.hk

v Affiliation

Dept. of Anesthesia and Intensive Care, CUHK

vi Country

9 Official Scientific Title of the Study

Prospective Randomized Controlled Trial Comparing Adaptive-support Ventilation ,INTELLiVENT-ASV and physician-led weaning on weaning patients cardiac surgery patients.

10 Public Title

Prospective Randomized Controlled Trial Comparing Adaptive-support Ventilation ,INTELLiVENT-ASV and physician-led weaning after Cardiac Surgery

i Public Title in Chinese 研究名稱

11 Short Title (Optional)

Early extubation after cardiac surgery

12 Countries of Recruitment

Hong Kong SAR, China

13 Research Ethic Review

i Has the study received appropriate ethics approval?

Yes

ii When is the approval date?

2012-07-05

iii Full Name of IRB/IEC

Please specify

iv IRB/IEC approval reference number

14 Medical Condition Being Studied

coronary artery disease

15 Intervention

i Types of intervention

Other

Please specify

Weaning protocols

ii Description/ name of Intervention/article

INTELLiVENT-ASV ventilation mode,
Adaptive-support ventilation mode

iii Dosage form of the intervention

iv Dosage of the intervention

v Duration of the intervention

During intensive care unit stay

vi Frequency of the intervention

16 Comparative Treatments

i Description/ name of comparative treatments

Physician-led weaning

ii Dosage form of the comparative treatments

iii Dosage of the comparative treatments

iv Duration of the comparative treatments

v Frequency of the comparative treatments

17 Key Inclusion and Exclusion Criteria

i Inclusion Criteria

Haemodynamically stable patients aged over 18 years, receiving mechanical ventilation support after elective coronary arterial bypass grafting will be consecutively included. Written informed consent will be obtained from each patient before surgery.

ii Exclusion Criteria

Preoperative exclusion criteria: patients older than 80 years or younger than 18 years, acute or chronic obstructive pulmonary disease (primary indication for ventilation), and concomitant valvular and/or aortic surgeries, major organ failure (liver disease, renal failure), history of seizure or stoke are excluded preoperatively.

Postoperative exclusion criteria: Severe early postoperative haemorrhage (chest tube drainage >500 ml/h), surgical complications needing reoperation, myocardial ischemia (ST-segment depression) lasting more than 30 min, postoperative cardiac failure necessitating high-dose inotropes or intra aortic balloon pump; refractory hypoxemia (ratio of arterial oxygen tension [PaO2] to fraction of inspired oxygen [FIO2] < 150 mmHg)

iii Age Minimum

18

iv Age Maximum

80

v Gender

Both Male and Female

18 Study Type

Interventional

19 Study Design

i Randomization

Randomized

Please specify

ii Nature of control

Active

iii Degree of masking

Single-blind

If Single-blind, who will be masked?

iv Group Assignment

Parallel

v Study Phase

Please specify

vi Study Objectives (Optional)

20 Anticipated trial start date

2012-10-01

21 Target Sample Size

90

22 Recruitment Status

Unknown

23 Primary Outcome

Duration of mechanical ventilation during intensive care unit stay, Frequency of manual setting during intensive care unit stay,
Frequency of alarms during intensive care unit stay

24 Secondary Outcome

Hospital length of stay during hostipal stay; Reintubation rate during intensive care unit stay;
Tidal volume within 10 minutes after weaning; Respiratory ratr within 10 minutes after weaning

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2015-01-14

27 Primary Registry and Trial Identifying Number

ChiCTR-TRC-11001505

28 Date of Registration in Primary Registry

2011-09-09

* Legacy Fields

i Recruitment Information Available?

Yes

ii Link to Recruitment Information

recruiting

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Trial History Detail on 2015-01-14