Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00308

2 Trial Registration Date

2011-11-24

i Registration Status

Prospective

3 Secondary IDs

2011/11/24

4 Source(s) of Funding

Department funded.

5 Primary Sponsor

Department of Anaesthesia and Intensive Care, PWH

6 Secondary Sponsor

N/A

Function

Please specify

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

i Name

Zhu Fang

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 1912(office)

iv Email

zhufang@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

Zhu Fang

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 1912(office)

iv Email

zhufang@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 with Routine Weaning Protocol after valve Surgery

10 Public Title

Prospective Randomized Controlled Trial Comparing Adaptive-support Ventilation with Routine Weaning Protocol after valve Surgery

i Public Title in Chinese 研究名稱

11 Short Title (Optional)

Early extubation by ASV after valvular 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?

2011-10-11

iii Full Name of IRB/IEC

Please specify

iv IRB/IEC approval reference number

14 Medical Condition Being Studied

valvular heart disease

15 Intervention

i Types of intervention

Other

Please specify

Weaning protocols

ii Description/ name of Intervention/article

Weaning protocol driven by adaptive-support ventilation mode

iii Dosage form of the intervention

iv Dosage of the intervention

v Duration of the intervention

During the ICU stay

vi Frequency of the intervention

16 Comparative Treatments

i Description/ name of comparative treatments

routine weaning ，which refers to the doctors in ICU will decide when and how long the ventilation uses, according to their experience and judgments.

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

Hemodynamically stable patients, over 18 years old; receiving mechanical ventilation support in ICU after valve surgery (isolated valve surgery or combined with CABG) will be consecutively included. Written informed consent will be obtained from every patient or their surrogates preoperatively.

ii Exclusion Criteria

Preoperative exclusion criteria will be patients older than 80 years or younger than 18 years (ethical reasons), acute or chronic obstructive pulmonary disease (primary indication for ventilation), major organ failure (liver disease, renal failure), history of seizure or stoke are excluded preoperatively.
Postoperative exclusion criteria will be severe early postoperative hemorrhage (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), seizure requiring treatment

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

2011-12-01

21 Target Sample Size

68

22 Recruitment Status

Complete

23 Primary Outcome

The primary endpoint of the study is duration of intubation. To fully assess the weaning process, the duration or weaning process will be cut into two parts: the duration of mechanical ventilation (from ICU entry to beginning of weaning from ventilator), duration of weaning (from the start of weaning to extubation), and the duration of intubation will be defined as from ICU entry to extubation).

24 Secondary Outcome

Secondary endpoints are (1) ventilatory parameters: duration of postoperative intubation, duration of mechanical ventilation, (2) clinical outcomes: postoperative hospital mortality, complications including major bleeding, sepsis, acute renal failure, myocardial infarction, respiratory failure, wound infection, reintubation rate, the need for ventilation in 48 hours after extubation, LOS in ICU, LOS in hospital, (3) respiratory parameters: levels of pressure support, RR, TV (mL), RR/TV, positive end expiratory pressure levels, FiO2, arterial pH, PaCO2 and PaO2.

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2014-11-11

27 Primary Registry and Trial Identifying Number

ChiCTR-TRC-11001794

28 Date of Registration in Primary Registry

2011-12-12

* Legacy Fields

i Recruitment Information Available?

Yes

ii Link to Recruitment Information

N/A

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Trial History Detail on 2014-11-11