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Trial History Detail on 2014-11-11

CUHK_CCT00308

2011-11-24

Prospective

2011/11/24

Department funded.

Department of Anaesthesia and Intensive Care, PWH

N/A

Zhu Fang

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

2632 1912(office)

zhufang@cuhk.edu.hk

Dept. of Anesthesia and Intensive Care, CUHK

Zhu Fang

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

2632 1912(office)

zhufang@cuhk.edu.hk

Dept. of Anesthesia and Intensive Care, CUHK

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

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

Early extubation by ASV after valvular surgery

Hong Kong SAR, China

Yes

2011-10-11

valvular heart disease

Other

Weaning protocols

Weaning protocol driven by adaptive-support ventilation mode

During the ICU stay

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

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.

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

18

80

Both Male and Female

Interventional

Randomized

Active

Single-blind

Parallel

2011-12-01

68

Complete

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).

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.

No

2014-11-11

ChiCTR-TRC-11001794

2011-12-12


Yes

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