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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR-TRC-11001794

Enrollment

Unknown

Registered

2011-12-12

Start date

2011-12-01

Completion date

Unknown

Last updated

2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

valvular heart disease

Interventions

Two groups:Weaning protocol driven by adaptive-support ventilation mode during the ICU stay versus routine weaning

Eligibility

Sex/Gender

Male

Age

18 Years to 80 Years

Inclusion criteria

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.

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
Duration of intubation, include the duration of mechanical ventilation (from ICU entry to beginning of weaning from ventilator), duration of weaning (from the start of weaning to extubation);	—

Secondary

Measure	Time frame
(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.;	—

Measure

Time frame

(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.;

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Countries

China

Contacts

Public ContactZhu Fang

alicewywong@cuhk.edu.hk+852 26321912

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026